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Citing Sources: What are citations and why should I use them?

What is a citation.

Citations are a way of giving credit when certain material in your work came from another source. It also gives your readers the information necessary to find that source again-- it provides an important roadmap to your research process. Whenever you use sources such as books, journals or websites in your research, you must give credit to the original author by citing the source. 

Why do researchers cite?

Scholarship is a conversation  and scholars use citations not only to  give credit  to original creators and thinkers, but also to  add strength and authority  to their own work.  By citing their sources, scholars are  placing their work in a specific context  to show where they “fit” within the larger conversation.  Citations are also a great way to  leave a trail  intended to help others who may want to explore the conversation or use the sources in their own work.

In short, citations

(1) give credit

(2) add strength and authority to your work

(3) place your work in a specific context

(4) leave a trail for other scholars

"Good citations should reveal your sources, not conceal them. They should honeslty reflect the research you conducted." (Lipson 4)

Lipson, Charles. "Why Cite?"  Cite Right: A Quick Guide to Citation Styles--MLA, APA, Chicago, the Sciences, Professions, and More . Chicago: U of Chicago, 2006. Print.

What does a citation look like?

Different subject disciplines call for citation information to be written in very specific order, capitalization, and punctuation. There are therefore many different style formats. Three popular citation formats are MLA Style (for humanities articles) and APA or Chicago (for social sciences articles).

MLA style (print journal article):  

Whisenant, Warren A. "How Women Have Fared as Interscholastic Athletic Administrators Since the Passage of Title IX." Sex Roles Vol. 49.3 (2003): 179-182.

APA style (print journal article):

Whisenant, W. A. (2003) How Women Have Fared as Interscholastic Athletic Administrators Since the Passage of Title IX. Sex Roles , 49 (3), 179-182.

Chicago style (print journal article):

Whisenant, Warren A. "How Women Have Fared as Interscholastic Athletic Administrators Since the Passage of Title IX." Sex Roles 49, no. 3 (2003): 179-182.

No matter which style you use, all citations require the same basic information:

• Author or Creator
• Container (e.g., Journal or magazine, website, edited book)
• Date of creation or publication
• Publisher 

You are most likely to have easy access to all of your citation information when you find it in the first place. Take note of this information up front, and it will be much easier to cite it effectively later.

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Benefits of Participating in a Study

In order to justify the use of participants in a research study, the IRB will look at the potential benefit of the study and weigh it against the risk in the study.  The benefit of a study can be to the participant in the study and/or the general community (which is described in the study’s protocol). 

Therapeutic studies , such as behavioral interventions, are conducted with the intent to  study alternative procedures for patient or client care .  For a therapeutic study to be justified the study procedures must offer care that is consistent with other therapeutic options, there are multiple options for treatment none of which are clearly preferred, and the risks are reasonable in relation to the potential benefit to participants.  For example, a psychologist may want to enroll a client in a study that he is conducting to evaluate an alternative approach to anorexia.  The treatment options for anorexia vary and the alternative approach to be studied offers similar potential benefits to other accepted approaches; thus the study can claim to offer therapeutic benefits to a participant.  In a non-clinical setting, an educator may want to enroll students in a study to evaluate the benefit of a new teaching approach to learning the alphabet. The accepted methods for teaching the alphabet vary and the new approach offers similar potential benefits to other accepted approaches; thus the study can claim to offer benefits to a participant.  There are two downsides to therapeutic studies.  If the participant does not benefit from the new approach, sometimes it can cause a reversal in their situation or have a negative impact on their progress.  In the anorexia example, the patient may not recover or could regress in their disease; in the education example, the student may not learn the alphabet or struggle with the learning process.  The researcher should provide options for the participant to receive the normal standard of care if such a result is possible.  The second downside is that often these studies use placebo controls in order to test the validity of the study’s claim.  In those cases, the participant does not receive care or is led to believe they are receiving care but in fact receives no care.  The Board generally requires that you notify participants in the consent form that there will be a control group who will not receive the treatment.  Often the Board will ask that if a participant participates in a control group, the participant will have the option to receive the experimental care if the benefit of the care proves to be valid.  Participants may need to be debriefed after the study to learn that they were part of the control group.  In some cases, lack of treatment may be unethical (for example, failing to treat the anorexic person or failing to teach a child the alphabet) and the Board will require that the control group receive at least the normal standard of care. 

Non-therapeutic studies  seek to  answer a scientific question without providing any treatment or direct benefit to a participant . In order for a non-therapeutic study to be approved, the risks in the study must be minimized according to sound scientific design and the risks are reasonable in relation to the knowledge gained by the study. Although the participant may not directly benefit from the study, the study may provide valuable information for a community or the general population.  As the level of risk increases in a study, so does the standard of scrutiny that the Board must apply.  For example, a study conducted by an inexperienced researcher with a mediocre design will not receive the same level of scrutiny if it is a minimal risk study versus a study with greater than minimal risk.  The Board does not comment on scientific merit unless the lack of scientific merit is a risk to participants.  This is more often a concern with student researchers; please see the  Guide for Student Researchers and Faculty Advisors  for more information.         

Please note that the Board does not consider payment to be a benefit.  Payments are used to encourage participation and should not be advertised as a benefit to participating in the study.   Please see  Payment  for more information.

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Citing sources: Overview

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Manage your references

Use these tools to help you organize and cite your references:

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If you have questions after consulting this guide about how to cite, please contact your advisor/professor or the writing and communication center .

Why citing is important

It's important to cite sources you used in your research for several reasons:

• To show your reader you've done proper research by listing sources you used to get your information
• To be a responsible scholar by giving credit to other researchers and acknowledging their ideas
• To avoid plagiarism by quoting words and ideas used by other authors
• To allow your reader to track down the sources you used by citing them accurately in your paper by way of footnotes, a bibliography or reference list

About citations

Citing a source means that you show, within the body of your text, that you took words, ideas, figures, images, etc. from another place.

Citations are a short way to uniquely identify a published work (e.g. book, article, chapter, web site).  They are found in bibliographies and reference lists and are also collected in article and book databases.

Citations consist of standard elements, and contain all the information necessary to identify and track down publications, including:

• author name(s)
• titles of books, articles, and journals
• date of publication
• page numbers
• volume and issue numbers (for articles)

Citations may look different, depending on what is being cited and which style was used to create them. Choose an appropriate style guide for your needs.  Here is an example of an article citation using four different citation styles.  Notice the common elements as mentioned above:

Author - R. Langer

Article Title - New Methods of Drug Delivery

Source Title - Science

Volume and issue - Vol 249, issue 4976

Publication Date - 1990

Page numbers - 1527-1533

American Chemical Society (ACS) style:

Langer, R. New Methods of Drug Delivery. Science 1990 , 249 , 1527-1533.

IEEE Style:

R. Langer, " New Methods of Drug Delivery," Science , vol. 249 , pp. 1527-1533 , SEP 28, 1990 .

American Psychological Association   (APA) style:

Langer, R. (1990) . New methods of drug delivery. Science , 249 (4976), 1527-1533.

Modern Language Association (MLA) style:

Langer, R. " New Methods of Drug Delivery." Science 249.4976 (1990) : 1527-33.

What to cite

You must cite:

• Facts, figures, ideas, or other information that is not common knowledge

Publications that must be cited include:  books, book chapters, articles, web pages, theses, etc.

Another person's exact words should be quoted and cited to show proper credit 

When in doubt, be safe and cite your source!

Avoiding plagiarism

Plagiarism occurs when you borrow another's words (or ideas) and do not acknowledge that you have done so. In this culture, we consider our words and ideas intellectual property; like a car or any other possession, we believe our words belong to us and cannot be used without our permission.

Plagiarism is a very serious offense. If it is found that you have plagiarized -- deliberately or inadvertently -- you may face serious consequences. In some instances, plagiarism has meant that students have had to leave the institutions where they were studying.

The best way to avoid plagiarism is to cite your sources - both within the body of your paper and in a bibliography of sources you used at the end of your paper.

Some useful links about plagiarism:

• MIT Academic Integrity Overview on citing sources and avoiding plagiarism at MIT.
• Avoiding Plagiarism From the MIT Writing and Communication Center.
• Plagiarism: What It is and How to Recognize and Avoid It From Indiana University's Writing Tutorial Services.
• Plagiarism- Overview A resource from Purdue University.
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• Last Updated: Jan 16, 2024 7:02 AM
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Home » Significance of the Study – Examples and Writing Guide

Significance of the Study – Examples and Writing Guide

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Significance of the Study

Definition:

Significance of the study in research refers to the potential importance, relevance, or impact of the research findings. It outlines how the research contributes to the existing body of knowledge, what gaps it fills, or what new understanding it brings to a particular field of study.

In general, the significance of a study can be assessed based on several factors, including:

• Originality : The extent to which the study advances existing knowledge or introduces new ideas and perspectives.
• Practical relevance: The potential implications of the study for real-world situations, such as improving policy or practice.
• Theoretical contribution: The extent to which the study provides new insights or perspectives on theoretical concepts or frameworks.
• Methodological rigor : The extent to which the study employs appropriate and robust methods and techniques to generate reliable and valid data.
• Social or cultural impact : The potential impact of the study on society, culture, or public perception of a particular issue.

Types of Significance of the Study

The significance of the Study can be divided into the following types:

Theoretical Significance

Theoretical significance refers to the contribution that a study makes to the existing body of theories in a specific field. This could be by confirming, refuting, or adding nuance to a currently accepted theory, or by proposing an entirely new theory.

Practical Significance

Practical significance refers to the direct applicability and usefulness of the research findings in real-world contexts. Studies with practical significance often address real-life problems and offer potential solutions or strategies. For example, a study in the field of public health might identify a new intervention that significantly reduces the spread of a certain disease.

Significance for Future Research

This pertains to the potential of a study to inspire further research. A study might open up new areas of investigation, provide new research methodologies, or propose new hypotheses that need to be tested.

How to Write Significance of the Study

Here’s a guide to writing an effective “Significance of the Study” section in research paper, thesis, or dissertation:

• Background : Begin by giving some context about your study. This could include a brief introduction to your subject area, the current state of research in the field, and the specific problem or question your study addresses.
• Identify the Gap : Demonstrate that there’s a gap in the existing literature or knowledge that needs to be filled, which is where your study comes in. The gap could be a lack of research on a particular topic, differing results in existing studies, or a new problem that has arisen and hasn’t yet been studied.
• State the Purpose of Your Study : Clearly state the main objective of your research. You may want to state the purpose as a solution to the problem or gap you’ve previously identified.
• Contributes to the existing body of knowledge.
• Addresses a significant research gap.
• Offers a new or better solution to a problem.
• Impacts policy or practice.
• Leads to improvements in a particular field or sector.
• Identify Beneficiaries : Identify who will benefit from your study. This could include other researchers, practitioners in your field, policy-makers, communities, businesses, or others. Explain how your findings could be used and by whom.
• Future Implications : Discuss the implications of your study for future research. This could involve questions that are left open, new questions that have been raised, or potential future methodologies suggested by your study.

Significance of the Study in Research Paper

The Significance of the Study in a research paper refers to the importance or relevance of the research topic being investigated. It answers the question “Why is this research important?” and highlights the potential contributions and impacts of the study.

The significance of the study can be presented in the introduction or background section of a research paper. It typically includes the following components:

• Importance of the research problem: This describes why the research problem is worth investigating and how it relates to existing knowledge and theories.
• Potential benefits and implications: This explains the potential contributions and impacts of the research on theory, practice, policy, or society.
• Originality and novelty: This highlights how the research adds new insights, approaches, or methods to the existing body of knowledge.
• Scope and limitations: This outlines the boundaries and constraints of the research and clarifies what the study will and will not address.

Suppose a researcher is conducting a study on the “Effects of social media use on the mental health of adolescents”.

The significance of the study may be:

“The present study is significant because it addresses a pressing public health issue of the negative impact of social media use on adolescent mental health. Given the widespread use of social media among this age group, understanding the effects of social media on mental health is critical for developing effective prevention and intervention strategies. This study will contribute to the existing literature by examining the moderating factors that may affect the relationship between social media use and mental health outcomes. It will also shed light on the potential benefits and risks of social media use for adolescents and inform the development of evidence-based guidelines for promoting healthy social media use among this population. The limitations of this study include the use of self-reported measures and the cross-sectional design, which precludes causal inference.”

Significance of the Study In Thesis

The significance of the study in a thesis refers to the importance or relevance of the research topic and the potential impact of the study on the field of study or society as a whole. It explains why the research is worth doing and what contribution it will make to existing knowledge.

For example, the significance of a thesis on “Artificial Intelligence in Healthcare” could be:

• With the increasing availability of healthcare data and the development of advanced machine learning algorithms, AI has the potential to revolutionize the healthcare industry by improving diagnosis, treatment, and patient outcomes. Therefore, this thesis can contribute to the understanding of how AI can be applied in healthcare and how it can benefit patients and healthcare providers.
• AI in healthcare also raises ethical and social issues, such as privacy concerns, bias in algorithms, and the impact on healthcare jobs. By exploring these issues in the thesis, it can provide insights into the potential risks and benefits of AI in healthcare and inform policy decisions.
• Finally, the thesis can also advance the field of computer science by developing new AI algorithms or techniques that can be applied to healthcare data, which can have broader applications in other industries or fields of research.

Significance of the Study in Research Proposal

The significance of a study in a research proposal refers to the importance or relevance of the research question, problem, or objective that the study aims to address. It explains why the research is valuable, relevant, and important to the academic or scientific community, policymakers, or society at large. A strong statement of significance can help to persuade the reviewers or funders of the research proposal that the study is worth funding and conducting.

Here is an example of a significance statement in a research proposal:

Title : The Effects of Gamification on Learning Programming: A Comparative Study

Significance Statement:

This proposed study aims to investigate the effects of gamification on learning programming. With the increasing demand for computer science professionals, programming has become a fundamental skill in the computer field. However, learning programming can be challenging, and students may struggle with motivation and engagement. Gamification has emerged as a promising approach to improve students’ engagement and motivation in learning, but its effects on programming education are not yet fully understood. This study is significant because it can provide valuable insights into the potential benefits of gamification in programming education and inform the development of effective teaching strategies to enhance students’ learning outcomes and interest in programming.

Examples of Significance of the Study

Here are some examples of the significance of a study that indicates how you can write this into your research paper according to your research topic:

Research on an Improved Water Filtration System : This study has the potential to impact millions of people living in water-scarce regions or those with limited access to clean water. A more efficient and affordable water filtration system can reduce water-borne diseases and improve the overall health of communities, enabling them to lead healthier, more productive lives.

Study on the Impact of Remote Work on Employee Productivity : Given the shift towards remote work due to recent events such as the COVID-19 pandemic, this study is of considerable significance. Findings could help organizations better structure their remote work policies and offer insights on how to maximize employee productivity, wellbeing, and job satisfaction.

Investigation into the Use of Solar Power in Developing Countries : With the world increasingly moving towards renewable energy, this study could provide important data on the feasibility and benefits of implementing solar power solutions in developing countries. This could potentially stimulate economic growth, reduce reliance on non-renewable resources, and contribute to global efforts to combat climate change.

Research on New Learning Strategies in Special Education : This study has the potential to greatly impact the field of special education. By understanding the effectiveness of new learning strategies, educators can improve their curriculum to provide better support for students with learning disabilities, fostering their academic growth and social development.

Examination of Mental Health Support in the Workplace : This study could highlight the impact of mental health initiatives on employee wellbeing and productivity. It could influence organizational policies across industries, promoting the implementation of mental health programs in the workplace, ultimately leading to healthier work environments.

Evaluation of a New Cancer Treatment Method : The significance of this study could be lifesaving. The research could lead to the development of more effective cancer treatments, increasing the survival rate and quality of life for patients worldwide.

When to Write Significance of the Study

The Significance of the Study section is an integral part of a research proposal or a thesis. This section is typically written after the introduction and the literature review. In the research process, the structure typically follows this order:

• Title – The name of your research.
• Abstract – A brief summary of the entire research.
• Introduction – A presentation of the problem your research aims to solve.
• Literature Review – A review of existing research on the topic to establish what is already known and where gaps exist.
• Significance of the Study – An explanation of why the research matters and its potential impact.

In the Significance of the Study section, you will discuss why your study is important, who it benefits, and how it adds to existing knowledge or practice in your field. This section is your opportunity to convince readers, and potentially funders or supervisors, that your research is valuable and worth undertaking.

Advantages of Significance of the Study

The Significance of the Study section in a research paper has multiple advantages:

• Establishes Relevance: This section helps to articulate the importance of your research to your field of study, as well as the wider society, by explicitly stating its relevance. This makes it easier for other researchers, funders, and policymakers to understand why your work is necessary and worth supporting.
• Guides the Research: Writing the significance can help you refine your research questions and objectives. This happens as you critically think about why your research is important and how it contributes to your field.
• Attracts Funding: If you are seeking funding or support for your research, having a well-written significance of the study section can be key. It helps to convince potential funders of the value of your work.
• Opens up Further Research: By stating the significance of the study, you’re also indicating what further research could be carried out in the future, based on your work. This helps to pave the way for future studies and demonstrates that your research is a valuable addition to the field.
• Provides Practical Applications: The significance of the study section often outlines how the research can be applied in real-world situations. This can be particularly important in applied sciences, where the practical implications of research are crucial.
• Enhances Understanding: This section can help readers understand how your study fits into the broader context of your field, adding value to the existing literature and contributing new knowledge or insights.

Limitations of Significance of the Study

The Significance of the Study section plays an essential role in any research. However, it is not without potential limitations. Here are some that you should be aware of:

• Subjectivity: The importance and implications of a study can be subjective and may vary from person to person. What one researcher considers significant might be seen as less critical by others. The assessment of significance often depends on personal judgement, biases, and perspectives.
• Predictability of Impact: While you can outline the potential implications of your research in the Significance of the Study section, the actual impact can be unpredictable. Research doesn’t always yield the expected results or have the predicted impact on the field or society.
• Difficulty in Measuring: The significance of a study is often qualitative and can be challenging to measure or quantify. You can explain how you think your research will contribute to your field or society, but measuring these outcomes can be complex.
• Possibility of Overstatement: Researchers may feel pressured to amplify the potential significance of their study to attract funding or interest. This can lead to overstating the potential benefits or implications, which can harm the credibility of the study if these results are not achieved.
• Overshadowing of Limitations: Sometimes, the significance of the study may overshadow the limitations of the research. It is important to balance the potential significance with a thorough discussion of the study’s limitations.
• Dependence on Successful Implementation: The significance of the study relies on the successful implementation of the research. If the research process has flaws or unexpected issues arise, the anticipated significance might not be realized.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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A citation is a formal reference to a published or unpublished source that you consulted and obtained information from while writing your research paper. It refers to a source of information that supports a factual statement, proposition, argument, or assertion or any quoted text obtained from a book, article, web site, or any other type of material . In-text citations are embedded within the body of your paper and use a shorthand notation style that refers to a complete description of the item at the end of the paper. Materials cited at the end of a paper may be listed under the heading References, Sources, Works Cited, or Bibliography. Rules on how to properly cite a source depends on the writing style manual your professor wants you to use for the class [e.g., APA, MLA, Chicago, Turabian, etc.]. Note that some disciplines have their own citation rules [e.g., law].

Citations: Overview. OASIS Writing Center, Walden University; Research and Citation. The Writing Lab and The OWL. Purdue University; Citing Sources. University Writing Center, Texas A&M University.

Reasons for Citing Your Sources

Reasons for Citing Sources in Your Research Paper

English scientist, Sir Isaac Newton, once wrote, "If I have seen further, it is by standing on the shoulders of giants.”* Citations support learning how to "see further" through processes of intellectual discovery, critical thinking, and applying a deliberate method of navigating through the scholarly landscape by tracking how cited works are propagated by scholars over time and the subsequent ways this leads to the devarication of new knowledge.

Listed below are specific reasons why citing sources is an important part of doing good research.

• Shows the reader where to find more information . Citations help readers expand their understanding and knowledge about the issues being investigated. One of the most effective strategies for locating authoritative, relevant sources about a research problem is to review materials cited in studies published by other authors. In this way, the sources you cite help the reader identify where to go to examine the topic in more depth and detail.
• Increases your credibility as an author . Citations to the words, ideas, and arguments of scholars demonstrates that you have conducted a thorough review of the literature and, therefore, you are reporting your research results or proposing recommended courses of action from an informed and critically engaged perspective. Your citations offer evidence that you effectively contemplated, evaluated, and synthesized sources of information in relation to your conceptualization of the research problem.
• Illustrates the non-linear and contested nature of knowledge creation . The sources you cite show the reader how you characterized the dynamics of prior knowledge creation relevant to the research problem and how you managed to effectively identify the contested relationships between problems and solutions proposed among scholars. Citations don't just list materials used in your study, they tell a story about how prior knowledge-making emerged from a constant state of creation, renewal, and transformation.
• Reinforces your arguments . Sources cited in your paper provide the evidence that readers need to determine that you properly addressed the “So What?” question. This refers to whether you considered the relevance and significance of the research problem, its implications applied to creating new knowledge, and its importance for improving practice. In this way, citations draw attention to and support the legitimacy and originality of your own ideas.
• Demonstrates that you "listened" to relevant conversations among scholars before joining in . Your citations tell the reader where you developed an understanding of the debates among scholars. They show how you educated yourself about ongoing conversations taking place within relevant communities of researchers before inserting your own ideas and arguments. In peer-reviewed scholarship, most of these conversations emerge within books, research reports, journal articles, and other cited works.
• Delineates alternative approaches to explaining the research problem . If you disagree with prior research assumptions or you believe that a topic has been understudied or you find that there is a gap in how scholars have understood a problem, your citations serve as the source materials from which to analyze and present an alternative viewpoint or to assert that a different course of action should be pursued. In short, the materials you cite serve as the means by which to argue persuasively against long-standing assumptions propagated in prior studies.
• Helps the reader understand contextual aspects of your research . Cited sources help readers understand the specific circumstances, conditions, and settings of the problem being investigated and, by extension, how your arguments can be fully understood and assessed. Citations place your line of reasoning within a specific contextualized framework based on how others have studied the problem and how you interpreted their findings in support of your overall research objectives.
• Frames the development of concepts and ideas within the literature . No topic in the social and behavioral sciences rests in isolation from research that has taken place in the past. Your citations help the reader understand the growth and transformation of the theoretical assumptions, key concepts, and systematic inquiries that emerged prior to your engagement with the research problem.
• Underscores what sources were most important to you . Your citations represent a set of choices made about what you determined to be the most important sources for understanding the topic. They not only list what you discovered, but why it matters and how the materials you chose to cite fit within the broader context of your research design and arguments. As part of an overall assessment of the study’s validity and reliability , the choices you make also helps the reader determine what research may have been excluded.
• Provides evidence of interdisciplinary thinking . An important principle of good research is to extend your review of the literature beyond the predominant disciplinary space where scholars have examined a topic. Citations provide evidence that you have integrated epistemological arguments, observations, and/or the methodological strategies from other disciplines into your paper, thereby demonstrating that you understand the complex, interconnected nature of contemporary research problems.
• Supports critical thinking and independent learning . Evaluating the authenticity, reliability, validity, and originality of prior research is an act of interpretation and introspective reasoning applied to assessing whether a source of information will contribute to understanding the problem in ways that are persuasive and align with your overall research objectives. Reviewing and citing prior studies represents a deliberate act of critically scrutinizing each source as part of your overall assessment of how scholars have confronted the research problem.
• Honors the achievements of others . As Susan Blum recently noted,** citations not only identify sources used, they acknowledge the achievements of scholars within the larger network of research about the topic. Citing sources is a normative act of professionalism within academe and a way to highlight and recognize the work of scholars who likely do not obtain any tangible benefits or monetary value from their research endeavors.

*Vernon. Jamie L. "On the Shoulder of Giants." American Scientist 105 (July-August 2017): 194.

**Blum, Susan D. "In Defense of the Morality of Citation.” Inside Higher Ed , January 29, 2024.

Aksnes, Dag W., Liv Langfeldt, and Paul Wouters. "Citations, Citation Indicators, and Research Quality: An Overview of Basic Concepts and Theories." Sage Open 9 (January-March 2019): https://doi.org/10.1177/2158244019829575; Blum, Susan Debra. My Word!: Plagiarism and College Culture . Ithaca, NY: Cornell University Press, 2009; Bretag, Tracey., editor. Handbook of Academic Integrity . Singapore: Springer Singapore, 2020; Ballenger, Bruce P. The Curious Researcher: A Guide to Writing Research Papers . 7th edition. Boston, MA: Pearson, 2012; D'Angelo, Barbara J. "Using Source Analysis to Promote Critical Thinking." Research Strategies 18 (Winter 2001): 303-309; Mauer, Barry and John Venecek. “Scholarship as Conversation.” Strategies for Conducting Literary Research, University of Central Florida, 2021; Why Cite? Poorvu Center for Teaching and Learning, Yale University; Citing Information. The Writing Center. University of North Carolina; Harvard Guide to Using Sources. Harvard College Writing Program. Harvard University; Newton, Philip. "Academic Integrity: A Quantitative Study of Confidence and Understanding in Students at the Start of Their Higher Education."  Assessment and Evaluation in Higher Education 41 (2016): 482-497; Referencing More Effectively. Academic Skills Centre. University of Canberra; Using Sources. Yale College Writing Center. Yale University; Vosburgh, Richard M. "Closing the Academic-practitioner Gap: Research Must Answer the “SO WHAT” Question." H uman Resource Management Review 32 (March 2022): 100633; When and Why to Cite Sources. Information Literacy Playlists, SUNY, Albany Libraries.

Structure and Writing Style

Referencing your sources means systematically showing what information or ideas you acquired from another author’s work, and identifying where that information come from . You must cite research in order to do research, but at the same time, you must delineate what are your original thoughts and ideas and what are the thoughts and ideas of others. Citations help achieve this. Procedures used to cite sources vary among different fields of study. If not outlined in your course syllabus or writing assignment, always speak with your professor about what writing style for citing sources should be used for the class because it is important to fully understand the citation style to be used in your paper, and to apply it consistently. If your professor defers and tells you to "choose whatever you want, just be consistent," then choose the citation style you are most familiar with or that is appropriate to your major [e.g., use Chicago style if its a history class; use APA if its an education course; use MLA if it is literature or a general writing course].

GENERAL GUIDELINES

1. Are there any reasons I should avoid referencing other people's work? No. If placed in the proper context, r eferencing other people's research is never an indication that your work is substandard or lacks originality. In fact, the opposite is true. If you write your paper without adequate references to previous studies, you are signaling to the reader that you are not familiar with the literature on the topic, thereby, undermining the validity of your study and your credibility as a researcher. Including references in academic writing is one of the most important ways to demonstrate your knowledge and understanding of how the research problem has been addressed. It is the intellectual packaging around which you present your thoughts and ideas to the reader.

2. What should I do if I find out that my great idea has already been studied by another researcher? It can be frustrating to come up with what you believe is a great topic only to find that it's already been thoroughly studied. However, do not become frustrated by this. You can acknowledge the prior research by writing in the text of your paper [see also Smith, 2002], then citing the complete source in your list of references. Use the discovery of prior studies as an opportunity to demonstrate the significance of the problem being investigated and, if applicable, as a means of delineating your analysis from those of others [e.g., the prior study is ten years old and doesn't take into account new variables]. Strategies for responding to prior research can include: stating how your study updates previous understandings about the topic, offering a new or different perspective, applying a different or innovative method of data gathering, and/or describing a new set of insights, guidelines, recommendations, best practices, or working solutions.

3. What should I do if I want to use an adapted version of someone else's work? You still must cite the original work. For example, maybe you are using a table of statistics from a journal article published in 1996 by author Smith, but you have altered or added new data to it. Reference the revised chart, such as, [adapted from Smith, 1996], then cite the complete source in your list of references. You can also use other terms in order to specify the exact relationship between the original source and the version you have presented, such as, "based on data from Smith [1996]...," or "summarized from Smith [1996]...." Citing the original source helps the reader locate where the information was first presented and under what context it was used as well as to evaluate how effectively you applied it to your own research.

4. What should I do if several authors have published very similar information or ideas? You can indicate that the idea or information can be found in the works of others by stating something similar to the following example: "Though many scholars have applied rational choice theory to understanding economic relations among nations [Smith, 1989; Jones, 1991; Johnson, 1994; Anderson, 2003], little attention has been given to applying the theory to examining the influence of non-governmental organizations in a globalized economy." If you only reference one author or only the most recent study, then your readers may assume that only one author has published on this topic, or more likely, they will conclude that you have not conducted a thorough literature review. Referencing all relevant authors of prior studies gives your readers a clear idea of the breadth of analysis you conducted in preparing to study the research problem. If there has been a significant number of prior studies on the topic, describe the most comprehensive and recent works because they will presumably discuss and reference the older studies. However, note in your review of the literature that there has been significant scholarship devoted to the topic so the reader knows that you are aware of the numerous prior studies.

5. What if I find exactly what I want to say in the writing of another researcher? In the social sciences, the rationale in duplicating prior research is generally governed by the passage of time, changing circumstances or conditions, or the emergence of variables that necessitate a new investigation . If someone else has recently conducted a thorough investigation of precisely the same research problem that you intend to study, then you likely will have to revise your topic, or at the very least, review this literature to identify something new to say about the problem. However, if it is someone else's particularly succinct expression, but it fits perfectly with what you are trying to say, then you can quote from the author directly, referencing the source. Identifying an author who has made the exact same point that you want to make can be an opportunity to add legitimacy to, as well as reinforce the significance of, the research problem you are investigating. The key is to build on that idea in new and innovative ways. If you are not sure how to do this, consult with a librarian .

6. Should I cite a source even if it was published long ago? Any source used in writing your paper should be cited, regardless of when it was written. However, in building a case for understanding prior research about your topic, it is generally true that you should focus on citing more recently published studies because they presumably have built upon the research of older studies. When referencing prior studies, use the research problem as your guide when considering what to cite. If a study from forty years ago investigated the same topic, it probably should be examined and considered in your list of references because the research may have been foundational or groundbreaking at the time, even if its findings are no longer relevant to current conditions or reflect current thinking [one way to determine if a study is foundational or groundbreaking is to examine how often it has been cited in recent studies using the "Cited by" feature of Google Scholar ]. However, if an older study only relates to the research problem tangentially or it has not been cited in recent studies, then it may be more appropriate to list it under further readings .

NOTE:   In any academic writing, you are required to identify which ideas, facts, thoughts, concepts, or declarative statements are yours and which are derived from the research of others. The only exception to this rule is information that is considered to be a commonly known fact [e.g., "George Washington was the first president of the United States"] or a statement that is self-evident [e.g., "Australia is a country in the Global South"]. Appreciate, however, that any "commonly known fact" is culturally constructed and shaped by social and aesthetical biases . If you are in doubt about whether or not a fact is considered to be widely understood knowledge, provide a supporting citation, or, ask your professor for clarification about how the statement should be cited.

Ballenger, Bruce P. The Curious Researcher: A Guide to Writing Research Papers . 7th edition. Boston, MA: Pearson, 2012; Blum, Susan Debra. My Word!: Plagiarism and College Culture . Ithaca, NY: Cornell University Press, 2009; Bretag, Tracey., editor. Handbook of Academic Integrity . Singapore: Springer Singapore, 2020; Carlock, Janine. Developing Information Literacy Skills: A Guide to Finding, Evaluating, and Citing Sources . Ann Arbor, MI: University of Michigan Press, 2020; Harvard Guide to Using Sources. Harvard College Writing Program. Harvard University; How to Cite Other Sources in Your Paper. The Structure, Format, Content, and Style of a Journal-Style Scientific Paper. Department of Biology. Bates College; Lunsford, Andrea A. and Robert Connors; The St. Martin's Handbook . New York: St. Martin's Press, 1989; Mills, Elizabeth Shown. Evidence Explained: Citing History Sources from Artifacts to Cyberspace . 3rd edition. Baltimore, MD: Genealogical Publishing Company, 2015; Research and Citation Resources. The Writing Lab and The OWL. Purdue University; Writing Tutorial Services, Center for Innovative Teaching and Learning. Indiana University; Why Cite? Poorvu Center for Teaching and Learning, Yale Univeraity.

Other Citation Research Guides

The following USC Libraries research guide can help you properly cite sources in your research paper:

• Citation Guide

The following USC Libraries research guide offers basic information on using images and media in research:

Listed below are particularly well-done and comprehensive websites that provide specific examples of how to cite sources under different style guidelines.

• Purdue University Online Writing Lab
• Southern Cross University Harvard Referencing Style
• University of Wisconsin Writing Center

This is a useful guide concerning how to properly cite images in your research paper.

• Colgate Visual Resources Library, Citing Images

This guide provides good information on the act of citation analysis, whereby you count the number of times a published work is cited by other works in order to measure the impact of a publication or author.

Measuring Your Impact: Impact Factor, Citation Analysis, and other Metrics: Citation Analysis [Sandy De Groote, University of Illinois, Chicago]

Automatic Citation Generators

The links below lead to systems where you can type in your information and have a citation compiled for you. Note that these systems are not foolproof so it is important that you verify that the citation is correct and check your spelling, capitalization, etc. However, they can be useful in creating basic types of citations, particularly for online sources.

• BibMe -- APA, MLA, Chicago, and Turabian styles
• DocsCite -- for citing government publications in APA or MLA formats
• EasyBib -- APA, MLA, and Chicago styles
• Son of Citation Machine -- APA, MLA, Chicago, and Turabian styles

NOTE:   Many companies that create the research databases the USC Libraries subscribe to, such as ProQuest , include built-in citation generators that help take the guesswork out of how to properly cite a work. When available, you should always utilize these features because they not only generate a citation to the source [e.g., a journal article], but include information about where you accessed the source [e.g., the database].

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Taking Research Outcomes to Target Beneficiaries: Research Uptake, Meaning and Benefits

• First Online: 10 December 2021

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• Clara Chinwoke Ifeanyi-obi 3  

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Every research is targeted to stimulate change through generating outcomes that proffer solutions to identified problems. Until these outcomes are mainstreamed into policy and practice, the expected research impact is yet to be felt. Researchers are therefore expected to possess the capacity not only to conduct viable research but to also mainstream their research findings into policy. This chapter is aimed at enlightening researchers on the importance of taking their research outcomes to target beneficiaries. It explained the concept of research uptake, highlighted the benefits of conducting research uptake to both the target audience and researchers and further prescribed a guide to researchers on the process of conducting research uptake. Researchers will find in this chapter guide on when to begin planning their research uptake programme, how to choose the right research uptake to implement, setting realistic objectives for their uptake programme, effective stakeholder mapping, developing effective uptake message, identifying effective communication channel and producing materials that clearly communicate uptake message.

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Ifeanyi-obi, C.C. (2022). Taking Research Outcomes to Target Beneficiaries: Research Uptake, Meaning and Benefits. In: Nwaichi, E.O. (eds) Science by Women. Women in Engineering and Science. Springer, Cham. https://doi.org/10.1007/978-3-030-83032-8_3

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• Published: 30 August 2023

Citation beneficiaries of discipline-specific mega-journals: who and how much

• Jing Li 1 ,
• Qiushuang Long 1 ,
• Xiaoli Lu 2 &
• Dengsheng Wu 3 , 4  

Humanities and Social Sciences Communications volume  10 , Article number:  541 ( 2023 ) Cite this article

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The emergence of mega-journals (MJs) has influenced scholarly communication. One concrete manifestation of this impact is that more citations have been generated. Citations are the foundation of many evaluation metrics to assess the scientific impact of journals, disciplines, and regions. We focused on searching for citation beneficiaries and quantifying the relative benefit at the journal, discipline and region levels. More specifically, we examined the distribution and contribution to citation-based metrics of citations generated by the five discipline-specific mega-journals (DSMJs) categorized as Environmental Sciences (ES) on Web of Science (WoS) from Clarivate Analytics in 2021: Sustainability, International Journal of Environmental Research and Public Health, Environmental Science and Pollution Research , Journal of Cleaner Production and Science of the Total Environment . Analysis of the distribution of citing data of the five DSMJs shows a pattern with wide coverage but skewness by region and the WoS category; that is, papers in the five DSMJs contributed 26.66% of their citations in 2021 to Mainland China and 22.48% to the ES. Moreover, 15 journals within the ES had their JIFs boosted by more than 20%, benefitting from the high citing rates of the five DSMJs. More importantly, the analysis provides clear evidence that DSMJs can contribute to JIF scores throughout a discipline through their volume of references. Overall, DSMJs can widely impact scholarly evaluation because they contribute citation benefits and improve the evaluation index performance of different scientific entities at different levels. Considering the important application of citation indicators in the academic evaluation system and the increase in citations, it is important to reconsider the real research impact that citations can reflect.

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Introduction

With the development of open access (OA) publishing and the success of PLOS ONE, a growing number of publishers have created journals termed “mega journals” (MJs) that aim for annual publication volumes of hundreds if not thousands of articles. According to Björk’s research ( 2015 ), to qualify as a mega-journal, a title should have a large volume, broad scope, soundness-only peer review and OA based on article processing charges (APCs). It is widely acknowledged that MJs are closely related to a considerable journal size (Busby 2015 ), which implies that a MJ features “a magnitude larger than an average journal in a particular field” (Zhang 2006 ), although other subjective criteria are under discussion. The emergence of MJs has attracted the attention of the academic community and received many comments on their impact on scholarly communication, which refers to the system through which research and other scholarly writings are created, evaluated for quality, disseminated to the scholarly community, and preserved for future use (Finlay et al. 2015 ). However, it is essential to recognize that publishing and citation practices vary significantly between different academic disciplines. Thus, further investigation is warranted to understand the specific impact of MJs in diverse disciplines on scholarly communication within those fields. Moreover, it is crucial to note that there exists notable diversity in the disciplinary composition of various MJs, leading to faster diffusion in certain scientific fields (Siler et al. 2020 ). This diversity and its implications prompt us to focus our research on a distinct category of MJs termed “discipline-specific mega-journals” (DSMJs). DSMJs are characterized by their substantial publication volume within a particular subject area, setting them apart from the broader scope of previous studies on general MJs.

The assessment of scientific research is an important facet of the entire academic communication system. In the context of research evaluation, citation-based indicators or metrics are applied to measure and compare the scientific performance of various scientific entities. Examples include the use of the journal impact factor (JIF) in the assessment of communication artifacts such as scholarly journals (Borgman and Furner 2002 ), cross-disciplinary citations in the analysis of interdisciplinary influences of a specific subject (Truc 2022 ) and citation performance to illuminate the scientific impact of nations (Smith et al. 2014 ; Li et al. 2023 ). More specifically, despite the controversy about their capacity to indicate research quality, these citation-based metrics are adopted as tools for authors to make decisions about publication outlets and are used by institutions in review, promotion, and tenure processes (Althouse et al. 2009 ; Niles et al. 2020 ; Pontika et al. 2022 ). Taking journal evaluation as an example, a journal that performs well in an evaluation (likely manifested as highly ranked in a field) benefits itself substantially and reputationally. Overall, when a citation is generated, a “benefit” is generated and “gained” by the cited journal, and its discipline and affiliated country/region in terms of a citation-based evaluation. In bibliometrics, the relationship between the generation and acquisition of citation benefits is often expressed as “referring/citing” and “cited”. Nevertheless, a gap in present studies to date is that MJs in a specific discipline exist as a separate and significant source of citations, which we believe is an important aspect of their impact on scientific communication. A great deal of research has focused on the impact of MJs, but a new concern is how the existence of DSMJs, despite being in a specific discipline, impacts assessment in the scholarly communication system. From this perspective, this study aims to answer the following questions:

Who benefits and to what extent from mega-journals with a specific disciplinary scope (DSMJs) at the discipline/region level?

Within a specific discipline, if there are journals with considerable outputs, who (which journal) has benefitted from them and to what extent?

Given field differences in citations (Ioannidis and Thombs 2019 ; Larivière and Sugimoto 2019 ) and the wide usage of established subject categories such as the WoS category in the evaluation of science, we selected a representative field from the WoS category list and screened DSMJs. The DSMJs in this paper meet the first principle of general MJs, i.e., publication outputs ranking at the top position within a discipline. Therefore, in this paper, the DSMJs studied are all relative to the full list of journals in a specific WoS category. This approach allows us to investigate factors related to MJs’ influence on the citation-based evaluation, with a specific focus on the disciplinary context. In terms of benefits, this study treats citations as benefits generated from DSMJs and “gained” by the cited journal, and its discipline and affiliated country/region that epitomizes the return of evaluation indicators. Moreover, at the journal evaluation level, the JIF score is calculated as the quotient of citations to citable items published in the two preceding years during the index year divided by the total number of citable items published in the two preceding years (Fischer and Steiger 2018 ). This citation-based metric, which prevails in scholarly communication, offers a measurable way to identify benefits by quantifying the increase in indicators. Bibliometrics provides the possibility of quantifying the impact of DSMJs on academic evaluation systems, specifically citation benefits to other scientific entities, i.e., journals, disciplines and regions. Therefore, a bibliometric and citation analysis method was used to serve the following two purposes: (1) first, to examine what disciplines and countries/regions achieve increased scores from the high rate of citations generated by DSMJs and to what extent and (2) to ascertain what journals benefit from being cited by DSMJs within the same discipline and to what extent.

The remainder of this paper is organized as follows. In Section 2, we provide materials and methods, i.e., the journal selection, the data collection and the equation designed to quantify how DSMJs contribute to JIFs and Immediacy Index scores. In Section 3, the empirical results are introduced. In Section 4, we discuss our results and offer some directions for further investigation. The final section is the conclusion.

Materials and methods

Dsmj selection.

“Environmental Sciences” (ES), one of the subject fields from the WoS categories that reported 126,235 citable items and ranked second in all 254 categories in Journal Citation Reports™ (JCR) in 2021, was chosen in this paper. The top five journals with the most outputs in ES were selected and examined. Specifically, according to the number of ‘Web of Science Documents’ in 2021 from Clarivate InCites TM , we chose the top five journals, i.e., Sustainability (Sustainability) , International Journal of Environmental Research and Public Health (IJERPH) , Science of the Total Environment (STOTEN), Environmental Science and Pollution Research (ESPR) and Journal of Cleaner Production (JCP). In the preliminary retrieval from JCR, five DSMJs published 43,210 articles in 2021 and 2,547,355 references, with more than 58.95 references per paper (see Table 1 ).

Data collection

To analyze the citing data, we obtained articles published in 2021 and their corresponding references by retrieving the five DSMJs in “Publication Titles” in the Web of Science TM (WoS) core collection, which includes the Science Citation Index Expanded (SCIE), the Social Science Citation Index (SSCI), the Arts & Humanities Citation Index (AHCI) and the Emerging Sources Citation Index (ESCI). We filtered out journal articles published between 2019 and 2021 in references (see Table 2 ) and exported them with author information (affiliated countries/regions), field information corresponding to journal classification, and journal information. At the discipline/region level, the quantification of the degree of benefits from DSMJs was based on the total number of citations that entities gained, while for a single journal, we chose two representative metrics in the JCR, the JIF and Immediacy Index (II), as the calculated basis. The II indicates how quickly articles in a journal are cited and can provide a supplemental perspective for evaluating journals specializing in cutting-edge research. Therefore, we matched the amount to 13,725 cited journals with their total citations, total articles, counts of citable items, and JCR data, including JIFs and II scores (for calculations, see Eqs. ( 1 ) and ( 2 ).

From Clarivate TM , the 2021 JIF is calculated using Eq. ( 1 ), and the 2021 II is calculated using Eq. ( 2 ).

A = Citations in 2021 to items published in 2019 and 2020; B = Number of citable items in 2019 and 2020

C = Citations in 2021 to items published in 2021;

D = Number of citable items in 2021

Quantitation method

Figure 1 illustrates a reference-citation relationship between papers of the five DSMJs and cited journals. Taking a cited journal, the Journal of Hazardous Materials , as an example, we use Eqs. ( 3 ) and ( 4 ) to calculate how much DSMJs benefitted the JIF and the II of this journal in 2021, respectively.

E = Citations in 2021 to citable items published in 2019 (1647) and 2020 (3228) from DSMJs;

F = Total citations in 2021 to citable items published in 2019 (13216) and 2020 (35217)

G = Citations in 2021 to citable items published in 2021 (1967) from DSMJs;

H = Total citations in 2021 to citable items published in 2021 (18782)

We give an example of how citations of the cited journals are contributed by papers of MJs. Limited to the citing data in Fig., the bibliometric analysis is as follows: Journal A wins 3 citations from MJs; Journal B wins 3 citations from MJs; Journal C wins 2 citations from MJs; and Journal D wins 3 citations from MJs. Therefore, MJs contributed 11 citations in 2021 to Journals A, B, C and D during 2019–2021.

Analysis and results

In our research, citations are a proxy for benefits in quantitative scientific evaluation, which are generated by DSMJs and gained by cited publications, and indirect “beneficiaries”. In 2021, the five DSMJs referenced amounted to 658,687 times to articles published in 2019–2021, corresponding to 13,725 journal beneficiaries. In the following analysis, we first identified the discipline beneficiaries that corresponded to research categories provided by the WoS by presenting the distribution of DSMJs’ citation benefits among subject fields and the contribution to the total citation of each field. Then, the distribution of DSMJs’ citation benefits among countries/regions was displayed to trace country/region beneficiaries. Finally, to identify beneficiaries at the journal level within this ES field and to further quantify the degree of benefits, we utilized the contribution indicators pertain to journal assessment.

Discipline beneficiaries

The cited documents can be divided into different research fields based on the WoS category to which their source publications belong. Those categories reflect the different subject content of the articles and correspond to the journal categories in the JCR. Note that 5073 journals were classified as “multiple”, which means multiple categories. We extracted their “most representative” category, where they obtained a better JIF percentile, for analysis at the disciplinary level. Those 658,687 citations to publications in 2019–2021 were distributed across 247 different categories out of the 254 indexed by WoS (see Supplementary Table S4 online). Specifically, in Table 3 , we display the top 20 WoS categories with the number of journals and their citation counts based on aggregation by category. ES, with 172 cited journals and 148,102 citations contributed by DSMJs, is the highest-ranking subject field, followed by Public, Environmental & Occupational Health and Green & Sustainable Science & Technology. In addition to the categories related to the environment, DSMJs cited substantial multidisciplinary literature, accounting for 3.26% of the citation benefits to the “Multidisciplinary Sciences”.

In the second step, we performed the contribution calculation, calculating the percentage of citations from the five DSMJs to the total citations received by each category of journals (PCC). Specifically, journals A, B and C were classified as “Energy & Fuels” and indexed in WoS. If papers published in 2019–2021 from A, B and C were cited 1000 times in total in 2021 and among these, 10 were cited by the five DSMJs, the PCC of “Energy & Fuels” was 1%. This calculation is a proxy indicator of DSMJs’ contribution to the citation benefits that each discipline gained. Because the number of citations has been extensively transformed into other various bibliometric indicators in research performance evaluation, it is often applied at the field level. Similarly, we considered the 2021 citations gained by publications published in 2019–2021. There were 4658 journals missing values in the JIF, the II or citable item fields because of the database or our collection process and resulting missing total citations in 2019–2021, which are required for benefits calculation. Thus, the remaining 600,231 references (91.13% of the 658,687 references) and corresponding 9067 journals were left for analysis at the discipline level. In Table 4 , ES with 802,169 total citations, of which 18.33% benefitted from five DSMJs, lagging behind the 25.55% gained by Environmental Studies.

Region beneficiaries

The corresponding author’s region is often considered the home base or origin of the study or paper (Ho 2012 ), and it plays a crucial role in determining the regional impact of the research. In this study, the addresses of corresponding authors available from the WoS database were used to identify regions with which the corresponding authors were affiliated. Note that 63,628 paper entries (9.6% of the 658,687 references) lacked information in the corresponding author address field and were purged from this subsection. In addition, some corresponding authors listed more than one institutional affiliation in the publication data. Specifically, for every 36,136 citations (6.1% of the total), benefits were shared by multiple regions. At the region level, there were 634,669 citation benefits left to be analyzed. Table 5 displays the number of citation benefits that each region received (total and from the five DSMJs), the percentage and the PCC.

According to the affiliation data of the corresponding authors, 595,059 references pertained to 182 countries/regions, and 634,669 regional citation benefits were generated (see Supplementary Table S5 online ). Table 5 partly describes the regional distribution of the 595,059 corresponding authors and displays the top 20 regional beneficiaries in terms of the comparative number of citations gained from DSMJs. The share of regions in citation benefits generated by DSMJs was skewed to China and the USA, which gained 26.66% and 11.35% of total DSMJ citation benefits in 2021. Note that when performing the quantification of the degree of benefits, we utilized the InCites TM dataset to obtain the number of times cited of publications in 2019–2021 belonging to the regions with which corresponding authors were affiliated as “total citations” (updated through the week of January 31st, 2023). We performed the contribution calculation by calculating the percentage of citations from the five DSMJs to the total number of citations of each region recorded by the WoS (PCC). As shown in the PCC column, the four countries (Spain, Turkey, Poland, Portugal) in the top 20 citation benefits from DSMJs were the only four regions whose PCCs were greater than or equal to the average PCC, 1.25%.

Journal beneficiaries within a specific discipline

In the previous section, we showed the contribution of the five DSMJs to the different subject fields, which was highly beneficial to ES. Next, we quantified the contribution of DSMJs to other journals within the discipline to determine the specified journal beneficiaries. From the data collection of 9067 journals mentioned in the previous section, we selected 243 journals belonging to ES. To determine which journals benefitted the most from citations from the five DSMJs, we calculated the two elaborated metrics mentioned above, the “contribution to JIF” and the “contribution to Immediacy Index” (see Tables 6 and 7 ), to quantify how DSMJs contributed to the cited journals within the same discipline.

In Table 6 , we show the beneficiaries based on the II. Only citations to items published in 2021 were used for the analysis. Sustainability is the journal that was cited most often, receiving 6416 citations to citable items in 2021 from the five DSMJs. According to Eq. ( 4 ), the five DSMJs contributed to increasing the II of Sustainability by 44.46%. This was followed by ESPR, which received 4524 citation benefits from the five DSMJs. The five DSMJs contributed to increasing the II of ESPR by 60.81%.

In Table 7 , we mainly focus on the beneficiaries of JIF. Citations to items published in 2019–2020 were used to analyze the change in 2021 JIFs. From the five DSMJs’ citations, STONEN benefited the most, receiving 140,940 citations from the five DSMJs to its items published in 2019–2020. The five DSMJs contributed to increasing the JIF of STOTEN by 22.62%. This was followed by JCP, which received 99,460. The five DSMJs contributed to increasing the JIF score of JCP by 25.71%. Sustainability ranked third with 69,045 citations contributed by the five DSMJs, for which the JIF score was increased by 31.17%.

Self-citations and intracitations of DSMJs

From the above analysis, we can see that the five DSMJs’ citations widely contributed to different regions and disciplines and markedly increased the JIFs and II scores of journals within the same subject field. Taking a further step, we separately calculated the self-citations and coupling citations of the five DSMJs in 2021, as shown in Table 8 and Fig. 2 . In Sustainability, there were 22,188 self-citations (accounting for 32.14% of the total citations) and 8.33% from the other four. In IJERPH, 17.99% of the total citations benefitted from self-citation and 6.43% from the other four. In STOTEN, there were 22,093 self-citations and 16,205 citations from others (accounting for 11.5% of the total citations) to items published in 2021. In ESPR, 9821 citations were from self-citation (accounting for 23.28% of the total citations) to items published in 2021 and 11.32% were from intracitations. In JCP, there were 15,241 self-citations (accounting for 15.32% of the total citations) and 15,083 citations from the other four DSMJ citations (accounting for 15.16% of the total citations) to items published in 2021.

This figure focuses on the five DSMJs’ citations in 2021 to their own items published in 2019–2021, which include two types of notable citations, i.e., DSMJs’ self-citations and intracitations, represented by each slice of the bar chart.

In 2006, the launch of PLoS ONE by the Public Library of Science introduced the mega-journal as a new type of scientific publication, significantly impacting scholarly communication (Lăzăroiu 2017 ). Specifically, MJs have emerged as vital channels for disseminating academic research, partly owing to their favorable performance in bibliometric evaluations (Solomon 2014 ; Wakeling et al. 2017 ). JCR 2020 metrics reveal that MJs contribute a 26.5% article share and excellent distribution in the JIF quartile (Kim and Park 2022 ). MJs relying on bibliometric measures as proxies for scientific influence and research performance, noticeably impact scholarly assessment processes. However, it is essential to consider that this influence extends beyond the MJ category and affects other areas, including relatively traditional journals and preferred disciplines, with implications that extend beyond merely elevating their positions.

This paper adopts a new perspective to investigate the impact of MJs’ discipline-specific counterparts (DSMJs) on scholarly evaluation, specifically in terms of their citing contribution to citation-based indicators. Based on their shared characteristic of considerable publication volume, we conduct exploratory research with a disciplinary context. Through our analysis of five DSMJs in Environmental Sciences, we demonstrate that the substantial number of articles in DSMJs results in significant citation benefits, benefiting both the journals themselves and their subject fields. Specifically, self-citation in these DSMJs increased citation rates by 15.32–32.14%. Within the same field, 15 journals increased their 2021 JIFs by more than 20% because of citations that benefitted from the DSMJs. It is broadly accepted that because the mean JIF of the journals in each discipline and the range of values that the JIFs take can differ greatly and that JIFs are comparable only within the same discipline, but processes of evaluation sometimes normalize the JIFs for scientific disciplines for comparison (Podlubny 2005 ; Van Leeuwen and Moed 2002 ; Van Leeuwen et al. 2003 ; Sombatsompop and Markpin 2005 ; de Moya-Anegón et al. 2005 ). Hence, in the evaluation of science, as revealed in the scientific classification, a rise in the overall JIF of journals belonging to the same discipline enhances disciplinary visibility. The disciplinary scope of our sampled journals is further validated by the fact that Environmental Science received the largest share of DSMJs’ citations according to our analysis of the subject field distribution. On the other hand, the reference distribution also implied the multidisciplinarity of DSMJs corresponding to Environmental Science since there was a considerable share of Multidisciplinary Sciences. At the disciplinary level, for Environmental Science, 18.33% of citations received in 2021 were contributed by the DSMJs.

The number of citations is a key variable often used for comparing scientific impact among countries. This metric is combined in indicators like citations per publication (Vinkler 2010 ) and the citation impact (the average number of citations a set of documents received) in InCite TM , aiding the identification of countries and institutions with the best performance for funding strategies (Leydesdorff et al. 2019 ). Citations generated by the DSMJs are distributed across regions and hence also generate explicit gains for each region based on regional measures of research impact. Because publication authorship plays an important role as a measure of regional research capacity (Smith et al. 2014 ), we credited a region with a publication if the corresponding authors were affiliated with institutions from that region. Mainland China led with 169,176 citation benefits from DSMJs in 2021. However, a high share of DSMJ citations does not necessarily translate into significant citation benefits. Even though there was some skewness in the regional distribution of citations generated by DSMJs (for example, 26.66 and 11.35% of the references have corresponding authors affiliated with Mainland China and the USA, respectively), these contributions do not stand out due to these countries’ own scientific impact, accounting for 0.92 and 0.5% of total times cited, respectively. Furthermore, 1.59, 1.25, 1.25 and 1.65% of the total citations of Spain, Turkey, Poland and Portugal, four countries with substantial citations, were contributed by DSMJs, while none of the other 16 top regional beneficiaries exceeded the average PCC. The average PCC, 1.25%, also provides a specific grasp of the DSMJs’ citation contribution to all regions as a whole. However, it is important to note that our study has not fully addressed certain crucial issues related to using corresponding authorship as a measure of regional citation beneficiaries. Specifically, this measurement may not fully account for the role of international cooperation within research teams. The regional affiliations of other authors involved in an article, particularly in cases with multiple authors, have not been explicitly considered in our analysis. To gain a comprehensive understanding of regional citation beneficiaries in scholarly evaluation, we recognize the need for future research to explore this aspect and its implications further.

Overall, DSMJs, focused on a specific discipline have generated substantial citation benefits for scholarly evaluation, giving beneficiaries at the above levels increases in citation metrics. However, for the overall scholarly evaluation, the increase in overall citation volume raises concerns about the applicability of the present citation-based measure to compare the impact of papers, researchers, and journals (Fire and Guestrin 2019 ). Our study found that one scientific entity that receives the greatest share of DSMJs’ citation distribution does not gain the most benefit. For entities facing a large number of citations from DSMJs, their overall citation impact plays a role in stability. Another point worth noting is that, the rapid diffusion of MJs has occurred more in some scientific fields than others (Siler et al. 2020 ). Our research on distribution at the discipline level and its contribution to subject fields demonstrates that DSMJs significantly impact their respective disciplines, leading to potential bias in the evaluation system based on the advantages of specific disciplines. Although citations are not necessarily the same as scholarly contributions, they are a useful proxy for them (Björk and Catani 2016 ). Considering the rapid development of mega-journals, their emergence in specific subject areas (Gong et al. 2020 ), and the broad but skewed impact on citation-based evaluation systems, it is worth rethinking the MJ model from the perspective of what is most conducive to the development of science to improve the quality of academic exchanges, make benefits reasonable, and further address some of their critiques. Of course, empirical support from various disciplines is needed to further validate these concerns.

MJs have become an established part of the scholarly communication landscape, offering a nontraditional publishing model that distinguishes them from traditional journals. Our study is dedicated to understanding their impact on scholarly communication by quantifying the influence of DSMJs on scholarly evaluation. We carefully examined the benefits that many scientific entities derive from the citations generated by these journals at the journal, discipline, and region levels. MJs expanded into specific subject areas, and their broad yet skewed impact on citation-based evaluation systems. It becomes essential to focus on enhancing the quality of academic exchanges, ensuring equitable benefits, and addressing some of the critiques associated with this nontraditional publishing approach.

Data availability

All data analyzed are contained in the paper and its supplementary information files.

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Acknowledgements

This research was supported by grants from the National Natural Science Foundation of China (Grant No. 72022021, 72301257), Natural Science Foundation of Guangdong Province of China, 2023A1515010982, Ministry of Education Humanities and Social Science Research projects, 21YJA870004.

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JL contributed to design of the work, wrote and revised the manuscript; QL performed data analysis, wrote and revised the manuscript; XL contributed to data collection and curation; DW contributed to the conception and design of the work, collected data and supervised the development of the research. All authors contributed to manuscript revision and approved the final manuscript.

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Li, J., Long, Q., Lu, X. et al. Citation beneficiaries of discipline-specific mega-journals: who and how much. Humanit Soc Sci Commun 10 , 541 (2023). https://doi.org/10.1057/s41599-023-02050-w

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Scope and Delimitation & Benefits and Beneficiaries of Research

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This module was designed and written with you in mind. It is here to help you master the Scope and Delimitation and Benefits and Beneficiaries of Research. The scope of this module permits it to be used in many different learning situations. The language used recognizes the diverse vocabulary level of students. The lessons are arranged to follow the standard sequence of the course. But the order in which you read them can be changed to correspond with the textbook you are now using. The module is divided into Two (2) lessons, namely: Lesson 1- Scope and Delimitation of research Lesson 2- Benefits and Beneficiaries of research After going through this module, you are expected to: a. define scope and delimitation of research; b. appreciate the scope, limitation and delimitation; and, c. write the benefits and beneficiaries of research.

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Who will benefit from your research and who will block it? How to identify stakeholders

Updated: Feb 21, 2020

Updated 2019 guide now available here .

For the original 2016 guide, continue reading...

________________________________________________

Researchers are increasingly expected by funders to identify and incorporate ‘beneficiaries’ into their work from the outset. Working out who might benefit from your work isn’t always easy though. Even if you do know who will benefit from your research, an equally important but often unasked question is: “who might be disadvantaged or lose out as a result of my research?” Even if you can answer both of these questions, there is another crucial question that every researcher should ask themselves: “who has the power to enable me to do my research and achieve impacts, and who has the power to block my work?”

It is just as important to identify individuals, organisations and groups who my be disadvantaged by the outcomes of your work, or who may block your research, as it is to know who your beneficiaries are, and who can help you. Knowing about potentially problematic stakeholders at the outset can give you the necessary time to adapt your research so that it no longer disadvantages those groups, or work out ways of ameliorating negative impacts before you run into opposition or achieve bitter-sweet impacts for one group at the expense of another.

What is a stakeholder?

A stakeholder is any person, organization or group that is affected by or who can affect a decision, action or issue. Rather than just identifying ‘beneficiaries’, a stakeholder analysis seeks to identify people, organisations or groups who may be either positively or negatively affected by your research. In addition to identifying those affected by your research, stakeholder analysis seeks to also identify those who might affect your ability to complete your research and generate impacts, either positively or negatively. These stakeholders might not directly benefit from or be negatively affected by your work, but they may have the power to enable or block your work from making a difference.

Why analyse your stakeholders?

It may seem self-evident that all the relevant stakeholders should be identified prior to any attempt to engage. However, it is surprising how often this step is omitted in research projects that need to work with stakeholders. In many cases this omission can significantly compromise the success of the research. For example, the project may miss crucial information that could have been provided, had they engaged with the right people.

In cases where very few stakeholders are identified or engaged with, this can lead to a lack of ownership of project goals, which can sometimes turn into opposition from certain stakeholders. In cases where a single important stakeholder has been omitted from the process, that organization or group may challenge the legitimacy of the work, and undermine the credibility of the wider project. Stakeholder analysis helps solve these problems by:

Identifying who has a stake in your work;

Categorising and prioritizing stakeholders you need to invest most time with; and

Identifying (and preparing you for) relationships between stakeholders (whether conflicts or alliances).

A successful stakeholder analysis will help you:

Start talking early to the right people, so that you can identify any major barriers to your work, and identify the people who can help you overcome those barriers. There is evidence that projects that engage with stakeholders early engender a greater sense of ownership amongst stakeholders, who are then more likely to engage throughout the lifetime of the project, and implement the recommendations of the work you have done together.

Know who you need to talk to: don’t just open your address book or talk to the ‘usual suspects’. Find out who might lose out, as well as who will benefit. Find out who is typically marginalized and left out, as well as the people and organisations that everyone knows and trusts. For example, Bec Colvin suggests drawing on methods from the arts to identify stakeholders using tacit knowledge or past experience. Those who are left out are usually the first to question and criticize work that they feel no ownership over.

Know what they’re interested in: you need to have a clear idea of the research issue at stake before you will be able to effectively identify stakeholders. But that doesn’t mean that the research questions and issues you explore together should be set in stone. As you begin to identify stakeholders, you will find out more about the nature of their stake in your research, and you may need to broaden your view of what is included in your work, if everyone is to feel that their interests are included.

Find out who’s got the most influence to help or hinder your work: some people, organisations or groups are more powerful than others. If there are highly influential stakeholders who are opposed to your project, then you need to know who they are, so that you can develop an influencing strategy to win their support. If they support your work, then it is also important to know who these stakeholders are, so you can join forces with them to work more effectively. There will be some influential stakeholders who have relatively little interest in your work. For example, they may have a broad remit that includes many issues that are more important and urgent to them than the specific focus of your research. Influential individuals are often busy and inaccessible, and you may need to spend significant time and energy getting their attention, before you are able to access their help.

Find out who is disempowered and marginalized: stakeholder analysis is often used to prioritise more influential stakeholders for engagement. Although time and resources may be limited, it is important not to use stakeholder analysis as a tool to further marginalize groups that are already disempowered and ignored. Many of these groups may have a significant interest in your research, but very little influence over the issues you are researching, and little capacity to help you achieve the impacts you want.

Identify key relationships so you avoid exacerbating conflicts and can create alliances that empower marginalized groups. It can be incredibly valuable to know in advance about conflicts between individuals, organizations or groups, so that you can avoid inflaming conflict and where possible resolve disputes. Through stakeholder analysis, it can sometimes become possible to create alliances between disempowered groups and those with more power, who share similar interests and goals, thereby empowering previously marginalized groups.

Methods for stakeholder analysis

Doing a proper stakeholder analysis doesn’t have to take a lot of time. We would recommend that you invite a small number of non-academics who know the stakeholder landscape well to help you with this task. But if you are short on time, then even if you just fill out the table below with your research team, you will be able to do far more impactful research than you would have done if you did not take this step.

The following methodology will take you approximately 2 days to complete, including between half a day and a day for an initial workshop, followed by a series of half hour telephone interviews to check your findings with key stakeholders (which is also a great opportunity to get their feedback on the focus of your research and start getting ownership as you adapt your work to stakeholder interests). The following steps are designed to be straight-forward and replicable, but this does not mean that they should be inflexibly applied. Local circumstances may require these steps to be adapted, to ensure that the stakeholder analysis is a tool that brings stakeholders together and facilitates active engagement in research.

1. Identify 2-4 cross-cutting stakeholders: Identify between 2-4 individuals from cross-cutting stakeholder organisations who operate at the scale of your research (if you have multiple study sites, you may need to do this for each site). The key criterion for selection is their breadth of interest in the issues you are researching, so that they are familiar with the widest possible range of organisations that might have a stake in your work. Aim to represent a range of different perspectives on the issue, so that you can facilitate debate about the relative interest and influence of different stakeholders (e.g. someone from a Government department or agency and someone from an NGO, not just people from different Government departments)

2. Invite cross-cutting stakeholders to half-day workshop: only 2-4 stakeholders plus project team should be present, as it is not the aim to represent all stakeholders at this workshop (this isn’t possible as we have yet to systematically identify them). This workshop should take approximately 4 hours (half a day), but if there is time, it is more relaxed to do this over a day:

Clearly establish the focus of the research that you think individuals, organisations or groups might have a stake in: it is important to be as specific as possible about your focus, so you can clearly identify who has a stake and who does not. You might want to consider the geographical or sectoral scope of the project (e.g. are you interested only in stakeholders at a local level, or is this a national issue that may involve national (or international) stakeholders? Which sectors of the economy or population are relevant to the research? A discussion about these sorts of questions at the start of the workshop should clarify any differing perceptions amongst the group, to avoid confusion later (approx. 15 mins);

Choose a well-known stakeholder organization and run through the stakeholder analysis for this organisation as an example. Draw copies of the extendable matrix below on flip chart paper and stick to walls, so that everyone can see what is being done. Explain that interest and influence can be both positive and negative (e.g. a group’s interests might be negatively affected and they may have influence to block as well as facilitate) (approx. 10 mins);

Ask participants to identify organisations, groups or individuals who are particularly interested and/or influential, and list them in the first column of the matrix at the bottom of this page. We've provided you with a blank table and a worked example to illustrate how this might look. Use the questions in the box below as prompts to help you identify as many stakeholders as possible (approx. 15 mins);

As a group work through each of the columns in the matrix, one stakeholder at a time, discussing the nature of their interest and reasons for their influence etc., and capturing the discussion as best as possible in the matrix (getting participants to capture points on post-it notes where necessary to avoid taking too long) (approx. 1-2 hours);

Take a break, and then invite participants to use the remaining time working individually to complete the columns for all the remaining stakeholders, adding rows for less interested and influential stakeholders as they go. Remind people to try and identify groups who might typically be marginalised or disadvantaged, but who still have strong interest in the research (approx. 1 hour);

Ask participants to check the work done by other participants, adding their own comments with post-it notes where they disagree or don’t understand (approx. 15 minutes);

Facilitate a discussion of key points people feel should be discussed as a group about stakeholders where there is particular disagreement or confusion and resolve these where possible (accepting differing views where it is not possible to resolve differences) (approx. 30 minutes);

Identify key individuals to check findings with after the workshop. Identify up to 5 individuals from particularly influential organisations, trying to get as wide a spread of different interests as possible (to do this, it may be necessary to start with a longer list and then identify people who are likely to provide similar views to reduce the length of the list). Finally consider if there are any particularly important stakeholders who have high levels of interest but low influence, who you do not want to marginalize and go through the same process, to arrive at a list of around 7-8 individuals who you can check the findings of the workshop with (approx. 20 mins).

3. Interview key individuals to check that no important stakeholders have been missed. Depending on the sensitivity of the material collected, you may only want to share the list of stakeholder organisations and their interests (not level of interest or anything else). For some of the individuals, it may be possible to check all columns in the matrix, but beware that some organisations may be upset that workshop participants perceive them to have low interest and/or influence. If the list of stakeholders from the workshop is sent in advance, these interviews should take no longer than 30 minutes each, and can be done by telephone.

4. Depending on how much the analysis changes from the workshop, you may want to check the amended version with workshop participants and make final tweaks.

5. Write-up: some columns can easily be converted into graphs, where there is numerical or categorical data involved. Consider carefully whether you want to all qualitative data to be made publically available in a form that is linked to specific named organisations and individuals, especially where this concerns conflicts between organisations. For a publically available version of the report, types of conflict may be summarized and the nature of stakes and types of influence may be summarized for different types of stakeholder, accompanied by graphs of numerical/categorical data e.g. farming organisations are most likely to be interested in certain aspects and have most influence over certain policy areas. The full stakeholder analysis matrix should be retained for use by the project team.

Images from a stakeholder analysis conducted for the UK Government's Department for Environment, Food and Rural Affairs, February 2016

Do your own stakeholder analysis with this template

We've developed an editable template that will guide you through doing your own stakeholder analysis, based on Prof Reed's "extendable matrix" approach - see Reed et al. (2009) and Reed and Curzon (2015) .

Download our stakeholder analysis matrix ( Word | PDF )

To give you a sense of what this can look like, you can view or download a worked example below, based on a hypothetical stakeholder analysis developed for a project funded by the Swedish International Development and Cooperation Agency (Sida), led by the Regional Environment Centre in cooperation with local partner IUCN ROWA. The Water SUM project , for which this was developed, is using this template to train country teams how to conduct a stakeholder analysis in preparation for local water security action planning in collaboration with stakeholders.

Click on the image above to view the full example

Alternatively, take a look at this stakeholder analysis we did for the UK Government's Department for Environment, Food and Rural Affairs to identify stakeholders in honeybee health, which informed the development of their National Pollinator Strategy last year. This project was done over a year, and involved Social Network Analysis and the analysis of many in-depth interviews, but you can get what you need for most research projects over a couple of days, using the methods described above. You can see the sort of thing that is possible with an in-depth stakeholder analysis like this in this presentation .

The template above is based on the template used in Fast Track Impact training. Both templates have columns that rate and then characterise the nature of people’s interest and their influence over the research and its impact. You can adapt the columns in this matrix to fit with your own purpose, bearing in mind that the more columns you add, the longer your workshop will take.

Thanks to WaterSUM project (www.watersum.rec.org) implemented by the Regional Environmental Center (www.rec.org) for funding that led to the production of this blog.

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Oncology drugs granted accelerated approval and regulatory outcome, based on follow-up time.

This figure excludes ongoing accelerated approvals with less than 5 years of follow-up (n = 74). Drug (year of accelerated approval) indicates accelerated approval indication. ALL indicates acute lymphoblastic leukemia; cHL, classical Hodgkin lymphoma; CLL, chronic lymphocytic leukemia; ER, estrogen receptor; FL, follicular lymphoma; MCL, mantle cell lymphoma; MM, multiple myeloma; MZL, marginal zone lymphoma; NSCLC, non–small cell lung cancer; PD-L1, programmed cell death ligand 1; PTCL, peripheral T-cell lymphoma; SCC, squamous cell carcinoma; and SLL, small lymphocytic lymphoma.

a Withdrawn drugs are represented by the lighter bars ending prior to the cutoff date of August 1, 2023.

This figure excludes ongoing accelerated approvals with less than 5 years of follow-up (n = 74). Drug (year of accelerated approval) indicates accelerated approval indication. ALL indicates acute lymphoblastic leukemia; AML, acute myeloid leukemia; BCC, basal cell carcinoma; CML, chronic myeloid leukemia; DLBCL, diffuse large B-cell lymphoma; dMMR, mismatch repair deficient; FL, follicular lymphoma; GEJ, gastroesophageal junction; HCC, hepatocellular carcinoma; MCL, mantle cell lymphoma; MM, multiple myeloma; MSI-H, microsatellite instability high; MZL, marginal zone lymphoma; NSCLC, non–small cell lung cancer; PD-L1, programmed cell death ligand 1; SCLC, small cell lung cancer; and TNBC, triple-negative breast cancer.

eFigure 1A. Cancer Drugs Granted Accelerated Approval Between January 2013 and July 2023 (and eFigure 1B including those with <5 years follow up) and Administrative Status

eFigure 2. Time From Accelerated Approval to Definitive Outcome for Cancer Drugs Granted Accelerated Approval Between 2013 and 2023, by Administrative Status

eFigure 3A. Administrative Outcome of Accelerated Approvals for Cancer Drugs Between 2013-2017

eFigure 3B. Efficacy Outcomes Used in Pivotal Trials to Support Accelerated Approvals for Cancer Indications Between 2013-2017

eFigure 4. Projected Time to Required Study Completion Following Accelerated Approval for Cancer Indications Approved Between 2013-2017

eFigure 5. Time Between Accelerated Approval and Definitive Outcome (Conversion or Withdrawal) for Cancer Indications Approved Between 2013 and 2017

eFigure 6. Difference Between Projected and Actual Definitive Outcome for Accelerated Approval Cancer Indications Approved Between 2013-2017

eFigure 7. Confirmatory Trial Endpoints Used for Conversion to Regular Approval

eTable 1. Clinical Benefit of Drug-Indication Pairs Granted Accelerated Approval Between 2013 and 2017 That Have Been Converted to Regular Approval

eTable 2. Examples of Indication Changes Between Accelerated and Regular Approval

eTable 3. Indications of Oncology Drugs Receiving Accelerated After January 2013 and Converted to Regular Approval by July 2023

eTable 4. Oncology Drugs Converted to Regular Approval Since 2021 on the Basis of Response Rate or Response Rate Plus Duration of Response

eTable 5. FDA-Required Postmarketing Commitments for Oncology Drugs Converted to Regular Approval Since 2021 on the Basis of Response Rate or Response Rate Plus Duration of Response

Data Sharing Statement

• Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization JAMA Health Forum Original Investigation August 19, 2022 This cohort study assesses the therapeutic value of drugs granted accelerated approval or conditional marketing authorization in the US and European Union from 2007 to 2021. Kerstin N. Vokinger, MD, JD, PhD, LLM; Aaron S. Kesselheim, MD, JD, MPH; Camille E. G. Glaus, BSc, JD, LLM; Thomas J. Hwang, MD
• Exposure to Cancer Drugs Without Confirmed Benefit After FDA Accelerated Approval JAMA Oncology Research Letter April 1, 2023 This cross-sectional study evaluates patient exposure to oncology drugs withdrawn from the US Food and Drug Administration (FDA) Accelerated Approval program. Ravi B. Parikh, MD, MPP; Rebecca A. Hubbard, PhD; Erkuan Wang, MA; Trevor J. Royce, MD, MPH; Aaron B. Cohen, MD, MSCE; Amy S. Clark, MD, MSCE; Ronac Mamtani, MD, MSCE
• Time to Confirmatory Study Initiation After Accelerated Approval of Drugs in the US JAMA Internal Medicine Research Letter July 1, 2023 This cross-sectional study examines and compares the time taken from the accelerated approval of cancer and noncancer drugs to the initiation of confirmatory studies in the US. Shelley A. Jazowski, PhD, MPH; Avi U. Vaidya, MPH; Julie M. Donohue, PhD; Stacie B. Dusetzina, PhD; Rachel E. Sachs, JD, MPH
• NCCN Recommendations of Cancer Drugs JAMA Network Open Original Investigation November 14, 2023 This cross-sectional study evaluates the basis for the supporting evidence and treatment preference ratings for cancer drugs and indications recommended by the National Comprehensive Cancer Network (NCCN) guidelines committees. Edward R. Scheffer Cliff, MBBS, MPH; Rachel S. Rome, MD; Aaron S. Kesselheim, MD, JD, MPH; Benjamin N. Rome, MD, MPH

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Liu ITT , Kesselheim AS , Cliff ERS. Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval. JAMA. Published online April 07, 2024. doi:10.1001/jama.2024.2396

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Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval

• 1 Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
• Original Investigation Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization Kerstin N. Vokinger, MD, JD, PhD, LLM; Aaron S. Kesselheim, MD, JD, MPH; Camille E. G. Glaus, BSc, JD, LLM; Thomas J. Hwang, MD JAMA Health Forum
• Research Letter Exposure to Cancer Drugs Without Confirmed Benefit After FDA Accelerated Approval Ravi B. Parikh, MD, MPP; Rebecca A. Hubbard, PhD; Erkuan Wang, MA; Trevor J. Royce, MD, MPH; Aaron B. Cohen, MD, MSCE; Amy S. Clark, MD, MSCE; Ronac Mamtani, MD, MSCE JAMA Oncology
• Research Letter Time to Confirmatory Study Initiation After Accelerated Approval of Drugs in the US Shelley A. Jazowski, PhD, MPH; Avi U. Vaidya, MPH; Julie M. Donohue, PhD; Stacie B. Dusetzina, PhD; Rachel E. Sachs, JD, MPH JAMA Internal Medicine
• Original Investigation NCCN Recommendations of Cancer Drugs Edward R. Scheffer Cliff, MBBS, MPH; Rachel S. Rome, MD; Aaron S. Kesselheim, MD, JD, MPH; Benjamin N. Rome, MD, MPH JAMA Network Open

Question   What is the clinical benefit of cancer drugs granted accelerated approval, and on what basis are they converted to regular approval?

Findings   In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did not improve overall survival or quality of life in confirmatory trials after more than 5 years of follow-up, with results not yet available for another 15% (7/46). Among drugs converted to regular approval, 60% (29/48) of conversions relied on surrogate measures.

Meaning   Although accelerated approval can be useful, some cancer drugs do not end up demonstrating benefit in extending patients’ lives or improving their quality of life.

Importance   The US Food and Drug Administration’s (FDA) accelerated approval pathway allows approval of investigational drugs treating unmet medical needs based on changes to surrogate measures considered “reasonably likely” to predict clinical benefit. Postapproval clinical trials are then required to confirm whether these drugs offer clinical benefit.

Objective   To determine whether cancer drugs granted accelerated approval ultimately demonstrate clinical benefit and to evaluate the basis of conversion to regular approval.

Design, Setting, and Participants   In this cohort study, publicly available FDA data were used to identify cancer drugs granted accelerated approval from 2013 to 2023.

Main Outcomes and Measures   Demonstrated improvement in quality of life or overall survival in accelerated approvals with more than 5 years of follow-up, as well as confirmatory trial end points and time to conversion for drug-indication pairs converted to regular approval.

Results   A total of 129 cancer drug–indication pairs were granted accelerated approval from 2013 to 2023. Among 46 indications with more than 5 years of follow-up (approved 2013-2017), approximately two-thirds (29, 63%) were converted to regular approval, 10 (22%) were withdrawn, and 7 (15%) remained ongoing after a median of 6.3 years. Fewer than half (20/46, 43%) demonstrated a clinical benefit in confirmatory trials. Time to withdrawal decreased from 9.9 years to 3.6 years, and time to regular approval increased from 1.6 years to 3.6 years. Among 48 drug-indication pairs converted to regular approval, 19 (40%) were converted based on overall survival, 21 (44%) on progression-free survival, 5 (10%) on response rate plus duration of response, 2 (4%) on response rate, and 1 (2%) despite a negative confirmatory trial. Comparing accelerated and regular approval indications, 18 of 48 (38%) were unchanged, while 30 of 48 (63%) had different indications (eg, earlier line of therapy).

Conclusions and Relevance   Most cancer drugs granted accelerated approval did not demonstrate benefit in overall survival or quality of life within 5 years of accelerated approval. Patients should be clearly informed about the cancer drugs that use the accelerated approval pathway and do not end up showing benefits in patient-centered clinical outcomes.

The US Food and Drug Administration (FDA) approves new drugs “shown to be safe and effective” when their proven benefits outweigh their risks. 1 In response to the HIV epidemic of the 1980s, the accelerated approval pathway was developed to provide a pathway for promising drugs treating unmet medical needs to reach the market sooner based on changes to unvalidated surrogate measures considered “reasonably likely” to predict clinical benefit. 2 , 3 After accelerated approval is granted, mandatory postapproval trials are then required to confirm patient benefit and indications are either converted to regular approval or withdrawn. These confirmatory studies are intended to determine whether—and how much—clinical benefit a new therapy may offer ( Box ). 4 , 5

Definitions of Key Regulatory Terms

Accelerated approval: an expedited pathway that allows for the approval of certain drugs treating serious conditions, for which there is an unmet medical need, based on changes in a surrogate end point.

Clinical end point: a trial outcome that measures improvement in how a patient feels, functions, or how long they survive (eg, quality of life, overall survival).

Confirmatory trial: for drugs granted accelerated approval, a requirement that drug manufacturers conduct a postapproval clinical trial measuring a clinical end point to confirm a drug’s effectiveness.

Indication: the specific medical context for which a drug has been tested in patients and approved for use by the US Food and Drug Administration (FDA). In the US, an approved medication may be prescribed by an appropriately licensed clinician for any reason—prescriptions for uses other than listed indications are known as “off-label” use.

Pivotal trial: sometimes known as preapproval trials, this is the general term given to any clinical trial that results in FDA approval.

Regular approval: approval granted based on changes to clinical end points. For drugs granted accelerated approval, regular approval occurs after confirmatory trials are conducted.

Surrogate end point: an outcome (eg, tumor size on a scan or a tumor marker blood test) that does not measure how a patient feels, functions, or survives, but is thought to predict clinical benefit.

Despite its origins in HIV treatment, accelerated approval is now most common in oncology, with approximately one-third of all oncology drug approvals using the pathway 6 and more than 80% of all accelerated approvals being granted for cancer therapies. 7 The surrogate measures typically used for accelerated approvals of cancer treatments include tumor response rate and progression-free survival (PFS), 8 based on imaging or laboratory tests.

The record of accelerated approvals for cancer drugs has been mixed. In one review covering 2008 to 2012, only 14% demonstrated improvements in overall survival 9 and more than 40% of confirmatory trials used surrogate measures to assess efficacy. 5 Because many surrogate measures in oncology correlate poorly with survival, 10 , 11 even after confirmatory trials, substantial uncertainty can remain as to the clinical benefit of accelerated approval drugs. 12 Many confirmatory trials have been delayed, with some products being used for more than a decade without confirming clinical benefit. 13 - 15 Furthermore, evidence suggests that trials powered to measure clinical outcomes are of similar duration to trials powered to assess surrogate measures, raising questions about whether confirmatory studies should use surrogate measures as their primary end points. 16 , 17

A recent cohort of cancer drugs granted accelerated approval was analyzed to determine clinical benefit and to assess FDA decisions to convert indications to regular approval.

We evaluated cancer accelerated approval indications from 2013 to 2023 and conducted 2 analyses. For approved indications with more than 5 years of follow-up, we assessed the timing of confirmatory trial completion and whether confirmatory trials ultimately demonstrated improvement in either overall survival or quality of life. For indications converted to regular approval, we analyzed confirmatory trial characteristics informing the conversion decision. This cohort study followed the STROBE reporting guidelines; it was not submitted for institutional review board review because it used publicly available data and was not considered human subjects research.

We used the published FDA Accelerated Approval list to identify accelerated approvals for cancer drug–indication pairs approved between January 2013 and July 2023. 18 For our first analysis of quality of life and overall survival, we analyzed accelerated approvals with more than 5 years of follow-up (approved through December 2017). For our second analysis focused on evidence supporting conversion decisions, we analyzed indications converted to regular approval before August 2023. Using the Drugs@FDA database 19 and established methods, 20 we extracted the date and indication of each accelerated approval, supplemental or original indication status, projected completion date for confirmatory studies, and—where applicable—the conversion or withdrawal date and regular approval indication.

We used multiple data sources to extract the names, National Clinical Trial (NCT) numbers, and end points of trials used to support accelerated approval from (in descending preference) FDA and manufacturer press releases, Drugs@FDA, and academic publications.

We identified the pivotal trial efficacy end point explicitly relied on by the FDA to support the granting of accelerated approval from the Drugs@FDA database, which sometimes differed from the primary efficacy end point of the pivotal trial (eg, primary end point is PFS, but accelerated approval based on overall response rate). When no end point was explicitly referenced, we assumed accelerated approval was based on the primary efficacy end point of the pivotal trial (eg, “Approval was based on data from [X] trial…”). In the few cases when multiple trials or efficacy end points were equally referenced for any approval determination, we conservatively chose the most clinically relevant end point (in descending preference: overall survival, PFS, response rate) or, when evaluating multiple efficacy trials with the same end point, the end point with greater magnitude of change.

For drugs that received regular approval, we used names and NCT numbers to search Google Scholar and ClinicalTrials.gov and chose the most up-to-date overall survival and quality-of-life data (ie, longest follow-up) from each confirmatory trial supporting regular approval in our first analysis. We assessed overall survival benefit as confirmed if there was a significant increase in overall survival in the trial’s primary intention-to-treat cohort. We characterized quality-of-life benefit as confirmed if there was a significant increase in a validated and prespecified global quality-of-life measure (eg, European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire) 21 at any prespecified time point or an increase in time to deterioration compared with standard care. 22 Withdrawn drugs were considered not to have shown clinical benefit.

We calculated the time between the accelerated approval date and projected completion date of confirmatory studies, as well as between accelerated approval and conversion or withdrawal date.

For the second analysis of evidence underlying conversion decisions to regular approval from 2013 to 2023, we used the above methods to assess confirmatory trials. To investigate indication changes throughout the approval process, 2 of the authors (I.T.T.L. and E.R.S.C.) manually compared accelerated and regular approval indications for each converted drug. Indications were classified as same, earlier line of therapy, broadened, narrowed, or other. Any indication that was both broadened and moved to an earlier line of therapy we placed in the “earlier line of therapy” category; we resolved differences by consensus. For indications converted to regular approval on response rate, we extracted postmarketing requirements from the FDA’s Postmarket Requirements and Commitments database.

Linear trend regression (for timing outcomes) and 1-sided Fisher exact test with a prespecified α of .05 (to compare supplemental and original indications) were used. All statistics were generated using Microsoft Excel version 16.

We identified 129 accelerated approvals for cancer indications from 2013 to 2023 (eFigure 1 in Supplement 1 ). Following accelerated approval, conversion to regular approval most commonly occurred in 1 to 2 years, withdrawals occurred evenly between 1 and 5 years, and—as of database lock—ongoing approvals had been most commonly waiting 3 to 4 years (eFigure 2 in Supplement 1 ).

Our first analysis included 46 indications with at least 5 years of follow-up, of which 24 (52%) were original indications and 22 (48%) were supplemental. Among these 46 indications, 29 (63%) were converted to regular approval, 10 (22%) were withdrawn, and 7 (15%) remained without a definitive outcome ( Figure 1 ); these proportions were similar between original and supplemental indications ( Table ).

These 46 drug-indication pairs were tested in 48 corresponding preapproval pivotal trials ( Table ). Nineteen drugs (41%) used preapproval pivotal trials with response rate as a primary end point, with a mean response rate of 50.6% (range, 16%-81%). Twenty-one drugs (46%) used response rate with duration of response, with a mean response rate of 40.7% (range, 13%-59%) and average median duration of response of 10.1 months (range, 5.3-13.8 months). PFS was used in 4 (9%) and overall survival and complete remission rate were each the primary basis for 1 accelerated approval (2%; eFigure 3 in Supplement 1 ).

Of the 29 indications converted to regular approval, we identified peer-reviewed articles with confirmatory trial quality-of-life data in 26 (90%) and a reported overall survival analysis in 25 (86%). Of these 29 indications, 20 (69%) demonstrated clinical benefit: 7 (24%) showed improvements in both overall survival and quality of life, 7 (24%) improved overall survival without demonstrating quality-of-life benefit, and 6 (21%) improved quality of life without improving overall survival ( Figure 1 ). The remaining 9 (31%) were converted without showing a benefit in either overall survival or quality of life in their confirmatory trials. Accelerated approvals for original indications reported higher rates of confirmed overall survival or quality-of-life benefit than supplemental indications, although this difference was not statistically significant (original: 11/14 [79%]; supplemental: 9/15 [60%], P  = .93; eTable 1 in Supplement 1 ).

Overall, 26 of 46 drug-indication pairs (57%) failed to demonstrate clinical benefit after at least 5 years of follow-up.

The duration from accelerated approval to projected confirmatory trial completion at the time of initial approval increased from 3.4 years in 2013 to 4.5 years in 2017 (eFigure 4 in Supplement 1 ). For the 10 withdrawn indications, duration from accelerated approval to withdrawal date decreased over the course of the study period from 9.9 years to 3.6 years. For the 29 converted indications, duration from accelerated approval to conversion to regular approval increased from 1.6 years to 3.6 years (eFigure 5 in Supplement 1 ). The time between projected trial completion to actual withdrawal or conversion narrowed over time (eFigure 6 in Supplement 1 ).

In our second cohort focused on conversion decisions, we identified 66 accelerated approval drug-indication pairs approved and either converted (48, 73%) or withdrawn (18, 27%) between 2013 and August 2023 ( Figure 2 and Figure 3 ). Eighteen drug-indication pairs (38%) had the same indication for accelerated and regular approval, 18 (38%) included an earlier line of therapy, 8 (17%) were broadened without moving to an earlier line of therapy, 3 (6%) were narrowed, and 1 (2%) was changed in an alternate way (examples in eTable 2 in Supplement 1 ; full list in eTable 3 in Supplement 1 ).

Of 48 converted indications, 19 (40%) were converted based on a pivotal trial(s) demonstrating improvement in overall survival. Twenty-one (44%) were converted based on improvement in progression-free, event-free, or disease-free survival, 5 (10%) on response rate plus duration of response, 2 (4%) on response rate, and 1 (2%) despite a negative confirmatory trial that showed no improvement in either overall survival or PFS (eFigure 7 in Supplement 1 ). 23 From 2013 to 2020, 0 of 28 conversions were based on response rate, whereas from 2021 to 2023, 7 of 19 conversions (37%) were based on response rate (2 were in chronic myeloid leukemia and used major molecular response rate, while 5 used overall response rate plus duration of response; eTable 4 in Supplement 1 ). The 7 conversions based on response rate were associated with 14 mandatory postmarketing commitments (eTable 5 in Supplement 1 ). Of the 48 converted indications, 40 reported PFS data with mean improvement in median PFS of 6.1 months (range, 1.2-23.9; mean hazard ratio, 0.53). Among the 23 converted drugs that reported overall survival data, mean improvement in median overall survival was 10.1 months (range, 3.7-18.5; mean hazard ratio, 0.64).

Despite more than 5 years of follow-up, most cancer drug indications granted accelerated approval between 2013 and 2017 did not demonstrate a benefit in overall survival or quality of life to patients in confirmatory trials by mid-2023. Among this cohort of accelerated approvals for cancer drugs, some improved overall survival, several ineffective drugs were withdrawn, multiple drugs had ongoing confirmatory studies, and others were converted to regular approval based on surrogate measures. Among drugs converted to regular approval, only two-thirds showed improvements in overall survival or quality of life, while one-third failed to show significant improvement in these outcomes. In the expanded cohort of conversion decisions from the past 10 years, the FDA has increasingly used surrogate measures such as response rate to support conversion from accelerated to regular approval.

Accelerated approvals in oncology have been the subject of much research. One study analyzed the therapeutic value of cancer drugs granted accelerated approval between 2007 and 2021 using ratings derived from international health technology assessment evaluations, finding about 40% of US accelerated approvals to be of high added therapeutic value. 23 However, health technology assessment ratings were only available for 62% of FDA-approved indications. Another study investigated 18 accelerated approvals for cancer drugs that failed to reach their primary end point in confirmatory trials, finding that 11 were voluntarily withdrawn by manufacturers, 6 remained on the market, and 1 was revoked by the FDA. 24 That investigation did not focus on the quality of a confirmatory trial’s primary end point and excluded approvals that reached their primary trial end point. By contrast, the current study analyzed 2 commonly reported, patient-centered end points to evaluate recent FDA accelerated approvals, while also reviewing recent trends in conversion decisions.

In an analysis of oncology drugs approved on the basis of surrogate end points from 2008 to 2013, Kim and Prasad 9 reported that 14% (5/36) demonstrated overall survival benefit with 5 years of follow-up, while another analysis covering 1992 to 2017 reported an overall survival benefit in 20% of accelerated approvals for cancer drugs. 5 Finding overall survival benefit in about one-third of accelerated approval indications in a more recent cohort suggests some progress in this area. An additional 5 drugs that demonstrated quality-of-life benefits are highlighted because these end points can also be meaningful for patients. Of the 29 converted indications in the first analysis, the current data revealed substantial overlap between trials showing quality-of-life (13 indications) and overall survival (14 indications) benefit (20 total), consistent with prior observations. 10

Characteristics of pivotal trials used to determine conversion from accelerated to regular approval were also analyzed. While 0 of 28 conversions from 2013 to 2020 were based on response rate (± duration of response), nearly 40% of conversions (7/19) from 2021 to 2023 used this surrogate measure to grant regular approval. Response rate, which measures tumor shrinkage, is a logical surrogate measure to use for accelerated approval because many tumor types are unlikely to spontaneously regress. 25 However, it cannot by itself determine whether a drug offers patients a clinical benefit, and—as highlighted by the FDA 26 —should therefore not be used without additional patient-centered information to establish regular approval.

One example of the potential issues created by the use of response rate as a study end point is the anti-CD19 antibody tafasitamab. Tafasitamab received accelerated approval in 2020 in combination with lenalidomide for the treatment of relapsed-refractory diffuse large B-cell lymphoma based on an objective response rate of 55% and a median duration of response of 21.7 months in the L-MIND trial ( NCT02399085 ). 27 Despite these promising markers of sustained tumor shrinkage, however, a recent real-world consortium study of tafasitamab-lenalidomide measured a median PFS of just 1.9 months. 28 Another example comes from bosutinib in chronic myeloid leukemia. In the BFORE trial ( NCT02130557 ), which compared bosutinib vs imatinib, bosutinib improved major molecular response rate but also substantially increased toxicity, which is not captured by this end point and therefore leaves uncertainty as to bosutinib’s net clinical benefit. These examples highlight the fallibility of using preliminary end points as the basis for conversion to regular approval.

Determining whether a drug offers a clinical benefit for a given accelerated approval indication before conversion to regular approval is important because it is substantially more difficult for the FDA to seek withdrawal of an indication after regular approval. While the FDA has requested withdrawal of 27 cancer drug indications approved via accelerated approval (including 17 since 2021 alone), 29 , 30 it rarely requests withdrawal of indications that have received regular approval. Furthermore, once a cancer drug is granted accelerated approval by the FDA, it is generally placed on treatment guidelines (though it is less likely to be “preferred” compared with regular approvals) 31 and covered by insurance providers. This results in clinical availability, 32 , 33 but is accompanied by patient exposure to the high prices 34 and out-of-pocket costs of many cancer therapies. 35 , 36 Because there is little difference in patient access between accelerated and regular approvals, confirmatory trials could routinely be powered to determine whether novel therapies offer patients a clinical benefit without compromising availability.

One goal of confirmatory trials should be to identify the population in which a drug is most effective. Olaparib in prostate cancer, 37 ibrutinib in mantle cell lymphoma, 38 and romidepsin in T-cell lymphoma 39 are recent examples in which subgroup analyses 40 , 41 of phase 3 clinical trials suggested divergent results among different populations. The current analysis of indication changes between accelerated and regular approval suggests, however, that indications are infrequently narrowed (2/48 [4%] of converted indications).

In addition to finding that approximately 40% of accelerated approval indications were moved to an earlier line of treatment at regular approval, indications were found to be broadened in a further 20%. When confirmatory trials are conducted in different populations from accelerated approval trials, uncertainty may persist regarding efficacy for a drug’s initial indication. This occurred in the case of romidepsin, when a negative confirmatory trial in a different indication (first-line treatment of peripheral T-cell lymphoma, in combination with chemotherapy) led to withdrawal of the drug, 38 while uncertainty remains around its original indication (as monotherapy in relapsed/refractory disease). Regulatory flexibility is important to appropriately target indications based on the best available clinical evidence; however, agencies should not allow this flexibility to generate confusing and nondefinitive evidence in disparate clinical contexts.

The current analysis of conversion decision timing decisions demonstrated a decrease in time from accelerated approval to withdrawal or conversion. In the current sample, this trend appears to be driven by more rapid withdrawal decisions, which decreased from more than 10 years to fewer than 2 years over the study period. Reducing the time from accelerated approval to completion of confirmatory trials is important. It would be unwise to pursue faster conversion decisions at the expense of gaining superior data with meaningful clinical end points, even if it takes longer to acquire.

The limitations of this study include, first, that only confirmatory trial data were looked at to evaluate the clinical benefit of cancer indications for accelerated approvals. Subsequent or larger trials in the same trial population could provide evidence of clinical benefit. Second, although this study was conducted with a minimum of 5 years of follow-up for the clinical benefit cohort, 7 drugs were still awaiting confirmatory trial results, and these drugs may yet show benefit. However, patients receiving these drugs still receive interventions of uncertain clinical efficacy in the meantime. 7 , 42 , 43 Third, because published overall survival and quality-of-life data were relied on in this study and primary data were not reevaluated, it is possible that clinical benefit may have been overestimated because statistical improvements in end points may or may not be clinically meaningful to patients depending on magnitude and methodologic approach (eg, trial population differs from real-world patients, 44 control group offered substandard care, 45 differential survey response rates 46 ).

Most cancer drugs granted accelerated approval did not demonstrate benefit in overall survival or quality of life within 5 years of accelerated approval. Patients should be clearly informed about the cancer drugs that use the accelerated approval pathway and do not end up showing benefits in patient-centered clinical outcomes.

Accepted for Publication: February 13, 2024.

Published Online: April 7, 2024. doi:10.1001/jama.2024.2396

Corresponding Author: Aaron S. Kesselheim, MD, JD, MPH, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, 1620 Tremont St, Ste 3030, Boston, MA 02120 ( [email protected] ).

Author Contributions: Drs Liu and Cliff had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: All authors.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Liu, Cliff.

Critical review of the manuscript for important intellectual content: All authors.

Obtained funding: Kesselheim.

Supervision: Kesselheim, Cliff.

Conflict of Interest Disclosures: Dr Kesselheim reported receiving personal fees from Gilead outside the submitted work and having served as an expert witness on behalf of the Leukemia & Lymphoma Society in litigation relating to royalties on venetoclax (2021-2022) and 2 cases in 2023 for the Federal Trade Commission related to pharmaceutical industry acquisitions (both now settled). No other disclosures were reported.

Funding/Support: This study was funded by Arnold Ventures and the Commonwealth Fund.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Meeting Presentation: Presented at the American Association for Cancer Research Annual Meeting; April 7, 2024; San Diego, CA.

Data Sharing Statement: See Supplement 2 .

Additional Contributions: We thank Linda Mileshkin, MBBS, MBE, Peter MacCallum Cancer Centre, Melbourne, Australia, for discussions regarding endometrial cancer. She did not receive compensation.

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ORIGINAL RESEARCH article

This article is part of the research topic.

Autism: The Movement (Sensing) Perspective a Decade Later

The Relation Between Specific Motor Skills and Daily Living Skills in Autistic Children and Adolescents Provisionally Accepted

• 1 University of Wisconsin-Madison, United States
• 2 University of Puerto Rico at Mayagüez, Puerto Rico

The final, formatted version of the article will be published soon.

Introduction: Motor skill difficulties are common in autistic children and are related to daily living skills (DLS). However, it remains unclear which specific motor tasks are most likely to impact overall DLS. This study sought to fill this gap. Methods and Results: In 90 autistic children and adolescents (ages 6-17 years), we found that fine/manual motor tasks, like drawing or folding, demonstrated significant medium-sized relations with DLS, even after accounting for IQ and sensory features, whereas tasks in the areas of bilateral coordination, upper-limb coordination, and balance only related to DLS (small effect sizes) prior to accounting for IQ and sensory features. When looking at an overall balance score, we found that IQ significantly interacted on the relation between overall balance and DLS. Discussion: These results further demonstrate the particular importance of fine/manual motor skills for DLS in autistic youth, even when accounting for IQ and sensory features. Indeed, accounting for sensory features strengthened the relations between fine/manual motor skills and DLS. Our findings provide evidence of the impact of cognitive factors on the relation between balance and DLS, indicating that it may be that autistic individuals with lower IQs experience relations between balance and DLS that are different than their peers with higher IQs. Our findings support the benefit of considering individual motor skills rather than domain-level information when assessing ways to promote DLS in autistic youth. The results further shed light on the importance of fine motor skills, as well as the unique relationship of balance and DLS in autistic individuals with lower IQs.

Keywords: Motor Skills, autism, Daily living skills, Cognition, age

Received: 06 Nov 2023; Accepted: 12 Apr 2024.

Copyright: © 2024 Skaletski, Cortes Cardona and Travers. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Mx. Brittany G. Travers, University of Wisconsin-Madison, Madison, 53715-1149, Wisconsin, United States

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Research suggests probiotics plus vitamin D supplements may benefit people with schizophrenia

Previous studies have questioned whether gut microbe imbalances and vitamin D deficiency may be linked to schizophrenia.

New research published in Neuropsychopharmacology Reports now indicates that taking probiotics plus vitamin D supplements may improve cognitive function in individuals with the disease.

For the study, 70 adults with schizophrenia were randomized to take a placebo or probiotic supplements plus 400 IU vitamin D daily for 12 weeks. Severity of the disease and cognitive function were evaluated by tests called the Positive and Negative Syndrome Scale (PANSS) and the 30-point Montreal Cognitive Assessment (MoCA), respectively.

A total of 69 patients completed the study. The MoCA score increased by 1.96 units in the probiotic-containing supplement group compared with the placebo group . Also, the percentage of patients with MoCA scores of 26 or higher (indicating normal cognition) rose significantly in the intervention group. Between-group differences in PANSS scores were not significant.

"Probiotics may be a novel way to treat mental disorders by regulating gut microbiota ," said corresponding author Gita Sadighi, MD, of the University of Social Welfare and Rehabilitation Sciences, in Iran.

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Undergraduate Research: Importance, Benefits, and Challenges

Developing and maintaining undergraduate research programs benefits students, faculty mentors, and the university. Incorporating a research component along with a sound academic foundation enables students to develop independent critical thinking skills along with oral and written communication skills. The research process impacts valuable learning objectives that have lasting influence as undergraduates prepare for professional service. Faculty members at teaching intensive institutions can enhance learning experiences for students while benefiting from a productive research agenda. The university in turn benefits from presentations and publications that serve to increase visibility in the scientific community. Whether projects are derived through student-generated or mentor-generated means, students benefit from completion of exposure to the hypothesis-driven scientific method.

Does research have an appropriate place in the undergraduate curriculum of an exercise science-based department? Published findings, as well as personal experience, suggest that developing and maintaining undergraduate research benefits the students, the faculty mentors, the university or institution, and eventually society at large. Additionally, the scientific community places increasing importance on research performed at primarily undergraduate institutions. Since 1978, the Council on Undergraduate Research has promoted research opportunities for faculty and students at predominantly undergraduate institutions. This national organization of individual and institutional members currently represents over 900 colleges and universities with 3,000 members ( 1 ). The National Conferences for Undergraduate Research provides a venue for undergraduates to present findings at an annual meeting which featured 2,800 presenters in 2008 ( 4 ).

Our belief is that an exercise science curriculum provides students the opportunity to become responsible professionals of competence and integrity in the area of health and human performance. The components necessary for professional competency in exercise-related fields include an understanding of the basic concepts and literature in the health-related specialty that is being studied and knowledge of the terminology or technical language used professionally. Incorporation of research methodology and the hypothesis-driven scientific process can build on this foundation through the development of independent critical thinking skills as well as oral and written communication skills. Independent thinking can instill in the undergraduate student the confidence to form one’s own conclusion based on available evidence. Undergraduate students who took classes in the same department where the research projects occurred reported having increased independence of thought, a more intrinsic motivation to learn, and a more active role in learning ( 3 ). Thus, the research process has a very favorable impact on valuable learning objectives as undergraduates prepare for their respective professions.

Further benefits to the student have been reported and disseminated from the SURE study (Survey of Undergraduate Research Experiences) ( 3 ). Undergraduate students who completed a mentored research program identified multiple areas from which they benefited. Of interest to us as advisors of an undergraduate research curriculum were the following items, which were reported as being positively impacted by the research experience (for a complete list, see Figure 1 of Ref. 3 ):

• Understanding the research process
• Understanding how scientists work on problems
• Learning lab techniques
• Developing skills in the interpretation of results
• The ability to analyze data
• The ability to integrate theory and practice

However, participation in an undergraduate research experience also benefited students in areas that can reach beyond academia ( 3 ).

• Having tolerance for obstacles
• Learning to work independently
• Understanding how knowledge is constructed
• Self confidence
• Understanding that assertions require supporting evidence
• Clarification of a career path

These benefits persisted after a 9-month follow-up survey, suggesting some lasting changes in undergraduates’ perceptions of the value of research. The fact that participation in undergraduate research helps students clarify a career path is valuable not only for the student, but for society at large. Students who complete an undergraduate research opportunity report increased interest in careers in the areas of science, technology, engineering, or mathematics ( 7 ). After an undergraduate research experience, 68% of students stated they had some increased interest in pursuing a STEM career (i.e. Science, Technology, Engineering, or Mathematics) ( 7 ). Additionally, 29% developed a new expectation of obtaining a PhD due to the experience of undergraduate research ( 7 ). This increased interest in careers in STEM benefits society at large as students develop interest in highly skilled professions that promote independence, collaboration, and innovation.

One of our own students, in response to a departmental exit survey stated, “research methodology is an important portion of the curriculum because graduate schools and supervisors are impressed when they see this on your resume, plus it’s a great experience.” We certainly believe undergraduate research to be an advantage when seeking post-graduate training; however, experience in research methodology is beneficial to all students not just those seeking further training after graduation. Ethical study and application of the scientific process develops critical thinking and independence necessary for achieving the highest standards of quality in scholarship, service and leadership. Developing skills in critical thinking and communication will allow students to emerge as leaders in multiple professions after graduation.

Faculty mentors also benefit from the undergraduate research process. The faculty mentor can initiate or continue a productive research agenda while at a teaching intensive institution. Interactions with students in the research process can enhance teaching ( 1 ) through the use of the scientific process as a class objective and by incorporating lab skills into the research process. This again facilitates the students moving from classroom theory to practical experience to solidify learning. Further, the university or institution will benefit from the publications, abstracts, and local, regional, national, or international presentations that increase visibility in the scientific community.

The scientific community also recognizes the importance of undergraduate research. Several national agencies have directly identified undergraduate research for funding initiatives. Funding for undergraduate research has been specifically identified by National Science Foundation which recently allocated $33 million for the Research Experiences for Undergraduates Program (REU) ( 6 ). This competitive mechanism typically funds an undergraduate student for a 10 week mentored project with a $3,000 – 4,000 stipend. The National Institute of Health has also announced the R15 mechanism or AREA grant which can provide an institution with up to $150,000 over 1 to 3 years for faculty mentored research at traditionally teaching institutions ( 5 ). An additional national funding opportunity for undergraduate students is the Howard Hughes Undergraduate Research Fellows Program providing a $2,600 stipend and possible tuition waiver ( 2 ).

Fifteen years ago, the faculty in our department had the foresight to require each senior to complete an individual research project. The implementation of a research project was quite a progressive idea for 1993, particularly in an undergraduate department housed within a liberal arts university whose mission was almost exclusively teaching focused. At the time, students in our department designed their projects, collected data, and presented their results in a single 15 week semester. The process of completing the research project has endured numerous transformations throughout the years and has morphed into its current state, a year-long faculty mentored research endeavor. The students learn research methodology and develop their research projects in one semester, while data is collected, analyzed, and presented during the second semester. The capstone assignments for the research projects include a journal-style manuscript, a poster presentation, and an oral presentation given to the faculty and staff of the department. Additionally, all students are required to present their research at local or state conferences and many have gone on to present at regional, national, and even international conferences.

Two schools of thought predominate when determining the research topics: a student-generated research topic versus a mentor-generated research topic. The former requires the student to perform a thorough literature review prior to the development of the project to ensure the project is novel. The student must then develop his or her own faculty-mentored methodology in order to appropriately answer the research question. This method provides a well-rounded research experience; however, the projects tend to be less sophisticated when compared to the mentor-generated projects. The more classic, mentor-generated projects often provide students with the opportunity for greater exposure to advanced laboratory techniques. However, as these projects are ongoing the student has less input into research design and methodology. Each method has its unique benefits and limitations, yet both result in excellent research experiences for the students. The decision to choose one method over the other often is dictated by the interests and future goals of the individual student. Those students who are interested in graduate or professional school tend to migrate towards mentor-generated projects in order to gain additional laboratory experience, though students can and often do chose a student-generated projects.

As we look to the future of our undergraduate research program, we continue to pursue opportunities to improve the quality of instruction and mentoring provided to our students with the hope that this will enrich the research experience for our students. We believe the greatest limitation to an established undergraduate research curriculum is monetary support. Many universities have an Undergraduate Research Office that provides small stipends for the students to travel and present research. We have found that our students are willing to present at regional or national conferences, but many do not have the funds for travel, registration, and professional membership dues, and therefore, often choose not to present their research. Thus, if we desire our students to gain the valuable experience of presenting at larger conferences (other than state or local), the financial burden lies with the student and/or the department. However, the precedent has been set within our university and other universities to seek external donations from community members who are committed to the development of future scientists. Such donations could provide the stimulus for increased research activity by making available stipends for students as well as for faculty mentors. The additional financial support would not only increase the quality of the research projects, but could also provide the much-needed support for students to present their data at larger conferences.

As faculty, we believe the research experience is extremely valuable for our students. It provides multiple benefits to students and faculty, as described above. However, those that have mentored research projects know it can be a trying or frustrating experience at times. Therefore, it is particularly gratifying to hear our students speak positively about the research process. One student reported last year, “I am really glad that I had the opportunity to complete a research project. It is an excellent tool for learning how to perform research, but also it has taught me skills I can use to complete any task.” For our purposes, this may be the primary goal of undergraduate research: students learn how to perform research, but they also learn problem-solving skills that translate to arenas beyond the classroom or laboratory.

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Breaking news, exercise at night for biggest benefit — if you fall into this group.

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Go ahead, sleep in and skip your morning workout. 

Getting in the majority of your exercise at night might actually be the most beneficial when it comes to living a longer life, a new study says . 

Researchers in Australia, who published their work in the journal Diabetes Care, looked at data from nearly 30,000 people over eight years and found that for those living with obesity, nighttime movement between the hours of 6 p.m. and midnight tended to be the most beneficial. 

What’s more, the researchers noted that any type of moderate to vigorous physical activity counted — it didn’t have to be a traditional sweat session. As long as you were getting your heart rate up, and getting breathless for a few minutes, it counted.

“We didn’t discriminate on the kind of activity we tracked, it could be anything from power walking to climbing the stairs, but could also include structured exercise such as running, occupational labor or even vigorously cleaning the house,” Dr. Matthew Ahmadi, National Heart Foundation postdoctoral research fellow at the University of Sydney, said in a release .

And it didn’t have to last long. Just three minutes of getting out of breath was found to hold some benefit. (Previous research has shown that just three minutes of exercise can have a strong positive impact on glucose control and lowered cardiovascular disease risk.) 

In fact, the researchers revealed, the frequency with which people undertook those short bouts of exercise seemed to be more important than their total amount of physical activity daily. In other words, getting your heart rate up for several minutes throughout your day might be better than one longer exercise session, followed by sitting in an office chair for the next eight hours. 

Using wearable devices to track movement, researchers collected data from UK Biobank for 29,836 adults over the age of 40 who were living with obesity. Nearly 3,000 of the participants also had Type 2 diabetes. 

The study participants wore their activity trackers nonstop for seven days, and researchers categorized their movement as being primarily in the morning, afternoon or evening. Then, researchers tracked what happened to those individuals over the next eight years. They monitored for deaths, major cardiac events (like a heart attack) and microvascular events (which includes things like being prescribed cholesterol or blood pressure medication), according to the American Heart Association . 

The researchers accounted for a number of lifestyle factors (including smoking, alcohol consumption, sedentary time, fruit and vegetable intake), plus other attributes like education levels, sex and age.

In the end, those evening workouts won out for those who live with obesity.

This information comes in contrast to several previous studies that have found it might be best to workout in the morning — especially if you’re looking to lose weight .

“Exercise is by no means the only solution to the obesity crisis, but this research does suggest that people who can plan their activity into certain times of the day may best offset some of these health risks,” Ahmadi explained.

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