clinical research recruitment strategies

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A comprehensive guide to clinical recruitment strategies.

According to  ACRP , 30% of individuals withdraw from a clinical study prior to completion, and recruiting a replacement costs an average of $19,533. Psychiatry has been poised for disruption for decades, and pharmaceutical companies are looking for solutions to bridge the gap between participant recruitment and drug research and development. This blog highlights a modernized approach to patient recruitment strategies to increase the volume of qualified participants that are more likely to remain active and engaged throughout the duration of the study.

Decentralized clinical trials

Conducting decentralized clinical trials is by far the most strategic and inventive avenue for pharmaceutical companies to distinguish themselves in a space that struggles with quick and thoughtful recruitment. Traditional clinical trial settings do not allow for convenience and significantly limit the pool of qualified participants simply due to the physical location of the study site, whereas the modern approach allows pharma companies to collect data remotely, from wherever the patients are located.

Current clinical trial recruitment challenges

There are four major obstacles that traditional, in-person clinical studies fail to achieve:

• Accessibility and convenience
• Efficient and cost-effective recruitment
• Diversity among participant groups
• Strategic digital recruitment campaigns

TechCrunch  reported nearly 70% of participants live more than 2 hours away from the clinic center, and 80% of clinical trials are canceled because they fail to meet the deadline to enroll patients on time.

Decentralized clinical recruitment for precision psychiatry

In December 2021, Alto Neuroscience and Cerebral announced a first-of-its-kind partnership for a  decentralized study in precision psychiatry  that will change pharmaceutical trial recruitment forever. Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience said:

“The introduction of this first-ever decentralized clinical trial in precision psychiatry broadens our formerly narrow view of drug discovery and development in mental health, allowing us to quickly deploy effective, accessible treatments in a way not previously possible.”

This study has leveraged Cerebral’s 200,000+ member network to recruit 200 eligible participants to undergo in home-evaluations using EEG, remote assessments at milestones of the study, clinical outcomes (i.e. depression scales), and at-home visits.

Patient-centric clinical trials

Logistically speaking, considerations around the participants’ needs are not at the forefront when traditional clinical trials are designed.  Whether it's commuting to the study sites or paying out-of-pocket for expenses, site-based clinical trials burden participants and hinder the possibility of successful recruitment. In other words, patient-centricty could be significantly enhanced beyond the current traditional clinical study design.

As noted by a recent PubMed article aimed to  define patient centricity for patients as it related to clinical research studies , patient-centricity was outlined as“'Putting the patient first in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family. Important principles for patients focused on education/information, cocreation, access, and transparency.”

Patient engagement is an essential aspect of all healthcare avenues, including the research and development of biopharmaceutical products. Patient-centric clinical trial frameworks are designed with a deep understanding of medical conditions, experiences, needs, and patient priorities (i.e. convenience, compensation, accessibility).

Leveraging an existing database

Traditional clinical trial recruitment strategies partner with labs and EHR systems to collect data on patients that could potentially qualify to participate in clinical trials.  

Reaching out to patients that meet trial eligibility criteria by using these third-party databases is a step in the right direction, but leaves your team with the responsibility to create and maintain the time-intensive recruitment campaign with quick deadlines, and participants can still be disqualified based on more specific eligibility requirements.

Clinical trial recruitment tools like Cerebral with proprietary EHRs offer an immensely competitive edge to pharmaceutical companies because of the incredibly refined data slicing and reporting capabilities. Cerebral’s structured data aggregated across prescriptions, diagnoses, labs, self-report surveys, medication fill rates, and better enables Cerebral to more rapidly and accurately identify candidates that likely meet trial eligibility criteria. 

For example, in the  Alto precision psychiatry study , Cerebral searches its patient pool for potential participants who are taking specific antidepressants, yet haven’t seen improvement in their major depressive disorder symptoms. To support further in-depth analysis of whether an individual will be a strong candidate for participation in the trial, Cerebral is able to pull details on individuals’ prescriptions, therapy frequency, comorbidities, and more. Cerebral is able to target individuals who are more likely to meet trial eligibility criteria, enabling individuals who have historically not seen any improvement in their depression systems to try a new approach to treatment, while also enabling Alto to analyze how an individual's distinct biology impacts their response to treatment. 

Recruit quickly and thoughtfully

A decentralized clinical trial program will rapidly advance the time to development of novel targeted medicines, specifically within psychiatry, a vertical in healthcare ripe for change and evolution.

By leveraging an existing database of patients and structured patient data, you can recruit quickly by creating a customized list of individuals that meet trial criteria within hours. 

Software for recruitment of patients for pharma trials

Software for recruitment of patients for pharma trials has the capability to tap into proprietary patient databases, to select pre-qualified patients that meet the eligibility parameters of the clinical trial.  Utilizing an EHR to identify relevant medical history, diagnoses, etc, allows pharmaceutical companies to target outreach to individuals who might be a good fit for a trial.

Marketing Strategy

Building a digital recruitment campaign comes with its own set of challenges.  You have to know what it takes to raise awareness and educate around clinical research, which marketing channels and formats to leverage based on your audience, and how to strategically target audiences to participate in studies.

Internal recruitment

In Cerebral’s case, our proprietary EHR and data collection capabilities enable powerful internal recruitment by having granular, detailed data about the patient base for pharmaceutical clients.  Internal recruitment as one avenue in your marketing strategy leads to much more relevant outreach and ultimately faster recruitment.

Example of a marketing campaign for clinical recruitment

Here is an example of a marketing campaign you might launch within your digital recruitment strategy:

You want to target individuals who are currently diagnosed and taking medication for bipolar I or II. Your company is conducting a clinical study for a new bipolar medication that could ease the side effects that these individuals are experiencing.  You need to consider what and where individuals are searching for when looking for alternative solutions to the current medication they are taking.  Maybe they are using Google and searching “new medication for bipolar I” or “best medication for bipolar disorder”).  You launch ads on Google targeting these keywords to drive individuals to the recruitment sign-up page.

This is just one example of what could be part of a comprehensive digital recruitment campaign.  Cerebral deeply understands the relationship between a robust data infrastructure and how it can be leveraged to strategically recruit participants.

To learn more about the capabilities and partnership opportunities with pharmaceutical companies,  visit our pharmaceutical services page .

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Clinical trial recruitment 101: how to recruit participants for a study, what is the best way to recruit participants for a study.

There is no simple answer to the question of how to recruit participants for a study in clinical research. The ideal recruitment strategy will depend on the specifics of the trial type and protocol, the capabilities of the sponsor and/or entity conducting the trial, the availability of eligible participants, and certain demographic and behavioral factors of those participants.

This article provides various resources for trial sponsors and clinical researchers to dive deeper into aspects of patient recruitment, and then answer the above question in a way that makes sense for the trial in question and their organization's unique needs.

Ethical considerations in research study recruitment

Before we proceed with answering “how to recruit participants for a study,” let’s do a quick recap of ethical considerations in research recruitment. There are a few important things to keep in mind related to regulatory compliance, ethics, and IRB submissions/approval. Keeping these concepts present through the design of the recruitment plan and during enrollment will make recruitment processes smoother by avoiding unexpected delays due to disapproval of study materials or re-approvals for unforeseen changes to said materials.

So, what are ethical considerations in relation to patient recruitment for clinical research studies? Essentially, the following rules and regulations are put in place to protect patients - in terms of their health and safety, their basic human rights, their data and personal privacy - and to ensure they are treated in an ethical manner (i.e., fairly and humanely) throughout the clinical trial, which begins with their first exposure to the study, be it through their physician or through promotional material. These considerations are provided in a bullet-point list to serve as a global overview that is easy to navigate – more information can be found by following the references provided at the end of the list.

1. All study materials must be approved by an IRB - Anything that will be seen by participants requires IRB approval prior to them seeing it. If modifications are made, a modification application must be submitted. Keep potential delays here in mind, and consider designing alternative versions to allow quick swap-out of pre-approved study materials.

2. Required content for recruitment materials - Recruitment materials generally must contain the following information:

• Clear indication that it is a research study (and not a therapy, program, etc.)
• Clear description of the purpose of the research study
• Basic eligibility criteria (those which a prospect can assess him/herself)
• Requirements of the participant (timeline, study visits, procedures, etc.)
• Location (of study sites or indication that it is a remote trial)
• Regulatory status of the investigational product/drug/device, if applicable
• Contact information

3. Prohibited content/terminology in recruitment materials - The following are forbidden from being included in recruitment advertisements:

• Promises of free healthcare or treatment
• Compensation that is highlighted or otherwise made to stand out from the rest of the text/content
• Claims that the investigational product is safe, effective, or equivalent to another treatment/product
• Claims that the trial will lead to health benefits or positive outcomes for the participant
• Exaggerated allusions to benefits, whether personal or societal
• Promises of discounts on the investigational product after its approval

4. Voluntary participation - Researchers must take explicit care to avoid coercion and inducements in research. Research participants may not be urged, forced, or coerced to take part in research studies.

5. Respect targeted ad bans and online privacy - Many social media platforms have banned the use of targeted advertising, wherein users’ sensitive personal information is used to target them. Ads not respecting these rules will not be approved. Recruitment outreach and communications must respect the privacy of every individual, and those interactions must not reveal their condition or identity to third parties or the public.

6. Data confidentiality and security - Data collected about potential participants should be treated as confidential, and should be stored appropriately (securely) to avoid data breaches and leaks of personal data that can compromise personal privacy.

7. Clear, direct, and unbiased language - Language should be understandable by the average person (layman terminology), and study objectives and protocol details should be laid out directly and clearly, avoiding misleading statements, coercive wording, and unfounded or exaggerated promises or claims.

8. Circumvent the therapeutic misconception - Study materials should deliberately avoid the “therapeutic misconception,” wherein participants believe that taking part in a study is guaranteed to benefit their health.

9. For further information on these points, please refer to:

• Recruitment of Research Participants Ethical Considerations
• Ethics in Clinical Research | Clinical Center Home Page
• Ethical Considerations in Clinical Research: A Comprehensive Review
• Clinical Trial Recruitment Practices: The Evolution of Ethical Considerations - WCG IRB

Powerful recruitment strategies: From planning to consenting

Our aim with this article is to provide sponsors and researchers with an overview of multiple concepts and considerations that come into play when designing and executing an effective patient recruitment strategy. We all know that recruitment can be a source of costly setbacks. Optimizing recruitment begins well before the recruitment process begins - due consideration of common challenges is necessary in order to understand the target population, promote diversity, and design recruitment strategies that are effective. This includes designing trials that are optimized for recruitment success. After discussing these challenges and considerations for designing recruitment strategies, we will provide further information on specific recruitment methods, including pointing to some powerful recruitment tools to supplement recruitment activities and the options available for outsourcing recruitment to specialists. Finally, we will link to explanatory content that goes into greater depth about various marketing and outreach strategies on different platforms to optimize exposure and speed up enrollment by reaching the right participants.

Importantly, recruitment success begins with designing trials and protocols that are already set up with recruitment success in mind! See our articles on patient centricity and decentralized clinical trials as a starting point. From here on, we will focus on optimizing recruitment, assuming that the trial has been designed in consideration of minimizing patient burden and enhancing participant experience. If that’s not the case, the following tips will still be entirely useful - but keep these concepts in mind for future trial designs, as patient centricity is slowly but surely becoming the norm rather than the exception in the clinical research industry.

Have a look through the following sections, which we have conveniently split up into three broad stages/concepts to help you pick and choose the guidance that is pertinent to the aspect of recruitment you’re looking to improve.

A. Background information to guide the design of a recruitment strategy

Recruitment challenges, eligibility criteria and screening, diversity and underserved populations

Recruiting into research studies is a complex undertaking. It requires a thorough understanding of your target population, including a clear definition of eligibility criteria for the trial, and it’s really useful to understand some of the (unfortunately, very) common issues that clinical researchers face in recruiting and enrolling a sufficient number of eligible participants on time.

Now, back to the design of the recruitment plan. To begin, check out the following resources to gain a deeper understanding of the clinical research recruitment landscape and common challenges encountered. This information is powerful for enabling you to turn these challenges into insights in order to come up with ways to address them and prevent them from becoming problematic.

• Three Clinical Trial Recruitment Challenges and Strategies to Overcome Them | Power
• Challenges in recruitment and retention of clinical trial subjects - PMC
• Enrollment in Clinical Trials: Statistics and Patient Recruitment Strategies | Power

Next, let’s consider the eligibility criteria. Nearly every trial has them, as these constraints act to encourage some degree of homogeneity in the sample, which in turn improves statistical power. In other words, constraining the sample allows researchers to control for certain covariates and prognostic factors, at least to some degree. These can include basic demographic factors such as biological sex and age, or extend to extremely specific criteria such as narrow ranges on a certain clinical parameter (hypothetical example: average systolic blood pressure of between 100 and 110 mmHg over the last 6 months). The trade-off is that strict eligibility criteria limit the pool of potential participants, and results obtained from very narrowly defined subsamples of the general population are less likely to be generalizable to the broader population. For extremely rare diseases, it makes more sense to use broader eligibility criteria so as not to unrealistically limit the sampling pool, and further since the rare condition is already a highly specific criterion. Eligibility criteria are also put in place as a safeguard against exposing high-risk patients to drugs or interventions that may be particularly risky for them.

Clinical researchers should aim to strike a balance between accessibility (to a sufficient participant pool for researchers, and fair accessibility to the study for diverse populations) and statistical power, and keep generalizability of results and the representativeness of the sample in mind. Check out the articles below to dive deeper into defining appropriate eligibility criteria and the factors involved in the decision:

• Clinical Trial Basics: Eligibility Criteria in Clinical Trials | Power
• Setting Eligibility Criteria - Ora Clinical
• Clinical Trial Eligibility Criteria | ASCO

The final consideration we want to touch upon in the context of planning and designing effective recruiting strategies is diversity in trial participation. This has become an important topic over the past years, as it has become evident that many minority groups and communities are (sometimes significantly) under-represented in clinical research studies. Diversity and inclusivity in clinical trials are important for multiple reasons. First, there are genetic differences amongst the broader population which can have significant impacts on how individuals respond to treatments - ensuring inclusion of diverse populations improves the representativeness of the study sample, and increases the likelihood that results can be generalized. Further, this helps monitor, to some extent, for potentially dangerous responses to a given treatment in certain groups, which may not have been identified in a sample that did not represent those groups. Second, the under-representation of certain groups can be a reflection of the reality of unequal access to healthcare and potentially beneficial novel treatments in certain communities. Not only is this a discrepancy that should be rectified for the sake of fairness and ethics, but increasing awareness and rapport in these communities can work toward dispelling negative perceptions and misconceptions that may act as confounding factors toward the lack of involvement. Check out the following article and the FDA guidance for more info:

• Clinical Trial Basics: Underserved Populations in Clinical Research | Power
• Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry | FDA

B. Recruitment methods and tools

Recruiting methods, powerful recruitment tools, and outsourcing

Now, let’s get to directly answering the question originally posed: How to recruit participants for a study.

The first topic here is pre-screening. Pre-screening is an invaluable step for narrowing down interested participants to high-interest/high-eligibility candidates, preventing costly screen failures down the line. In many cases, pre-screening can be set up and then function passively, greatly reducing the workload on sites and investigators. At Power, our speciality is matching patients with relevant clinical trials, which is powered by our patient-friendly platform. The powerful pre-screening feature serves a double purpose in that prospects’ answers to sponsor-defined pre-screening questions are used to create a database of high-interest participants, which makes it extremely easy for sponsors to reach out to further them through the recruitment funnel. If you’re recruiting for a study, reach out to us and verify your trial on our platform with a streamlined pre-screening feature. Check out the following link for more information on pre-screening and screening:

• Clinical Trial Basics: Pre-Screening and Screening | Power

In terms of executing the recruitment and outreach strategies, there are various ways to go about it. The following links will bring you to great resources outlining specific recruitment methods, focused on patient-centric recruiting strategies and tools that can help you succeed in recruitment. Have a read through; we’re sure you’ll find something that helps you design the best recruiting strategies possible for your trials:

• Recruiting for clinical trials: Patient-centric clinical trial recruitment strategies that work | Power (Scroll down to “Recruiting for clinical trials: Six patient-centric recruiting strategies”)
• 9 Clinical Trial Recruitment Tools to Try in 2023 | Power

If all of this seems like simply too much to take on - this is often the case for smaller organizations - there may be real value in considering outsourcing recruitment efforts to specialists in clinical research recruitment. These could be a dedicated clinical research recruiter, or CROs or other providers who offer recruitment services and bring their own site and patient databases to the table, amongst other operational services and technological solutions:

• Top 10 Patient Recruiting Companies for Clinical Trials in 2023 | Power

C. Clinical trial marketing and outreach campaigns

Guidance for digital marketing campaigns on social media, Google, and Facebook

In today’s clinical research industry, which is more connected than ever before yet still suffers from poor recruitment statistics, trial recruitment specialists and sponsors have turned to marketing tactics to expand exposure to their trials. Capturing the attention of people, who are bombarded by advertisements on a daily basis - an estimated 4,000 to 10,000 per day, in fact - is increasingly difficult (and that statistic is from a few years ago already!). Thus, there is a lot of value in leveraging marketing techniques to increase exposure of your trial. As a starting point, have a look through our introductory article on the topic of clinical trial marketing:

• How-to Guide: Clinical Trial Marketing | Power

When it comes down to specifics, things can begin to look quite complex. Different social media platforms with differing user demographics, different ad types, and distinct rules and regulations, combined with the fast-paced nature of social media and digital marketing, highlights the potential value in partnering with a digital marketing expert. However, with some dedication and time, it’s not all that hard to navigate these platforms and design and launch highly effective recruitment campaigns on social media.

We recommend first reading through the concise and helpful “Use of Social Media” section of this guidance published by the Iowa State University Institutional Review Board , which serves as a checklist to ensure that you have the appropriate perspective and awareness of pertinent issues when going into this area. Relatedly, our overview piece on social media recruitment goes into depth on important considerations for patient privacy, targeting methods in light of targeted ad bans, common challenges and potential solutions in social media recruitment, designing and monitoring a recruitment campaign, and gives an introduction to the major platforms and their specific ad campaign types:

• Designing Effective Social Media Clinical Trial Recruitment Campaigns in 2023 | Power

If you’re interested, take a look at more detailed guidelines for two of the major online marketing channels that have proven to be extremely effective for many clinical trials: Facebook and Google.

• Facebook Clinical Trial Recruitment: Strategies for Effective Facebook Advertising in Medical Research
• Google Clinical Trial Advertising: Getting the Most Out of Google Ads for Recruitment | Power

We hope that this global overview of important considerations, challenges, and methods of recruitment has been useful, and that you can walk away with some helpful information for how your organization or trial team might go about deciding how to recruit participants for a study. There are a lot of options for patient recruitment, but perhaps the most important aspect of recruiting into research studies that we would like to highlight is the benefit of proper prior research and planning. Past trials offer extensive insight into what has and has not worked, either in your organization or for trials of a similar nature, and taking time to define and then understand your target population - their needs, their struggles, and where they are most active - will go a long way in optimizing your recruitment efforts. Bring patient experience and recruitment success to the table early on, in trial design and protocol development, to set the study up for successful and quick recruitment from the get-go. Whatever strategies and tips you decide to adopt, keep regulatory compliance and IRB approval in mind, and remember that recruitment is a skill. Especially in these times of extreme connectivity and exposure to advertisements, learning to reach your target participants with messages that resonate with them is an art, which you can only improve upon with each trial and each iterative effort.

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Participant and patient engagement, recruitment, and retention

Need assistance with participant engagement, recruitment, or retention?

Get help with participant engagement, recruitment, or retention.

Contact the Recruitment Innovation Center (RIC):

• Submit a help request

Successful participant engagement, recruitment, and retention in research studies  can be one of the most challenging aspects of conducting research. Effective and efficient engagement, recruitment, and retention strategies are critical to successfully achieving enrollment targets while also prioritizing participant safety, well-being and trust.

This page provides resources, best practices and tools for developing and implementing robust engagement, recruitment, and retention strategies. However, it’s important to note that there is no one-size-fits-all approach to good planning. In fact, effective engagement, recruitment and retention planning should:

• Be proactive
• Start upstream at study design
• Anticipate and account for downstream barriers
• Be data-driven and evidence-based
• Be thoughtful and realistic
• Include input from all relevant stakeholders
• Be participant-centered
• Be resourced appropriately
• Be adjusted as needed

Request a free consultation with the Recruitment Innovation Center or consider the Consultations and Help resources available in the “Related Resources” section.

Population or cohort discovery

Participant or patient engagement and recruitment strategies.

Once the cohort or population has been identified, recruitment plans should consider which strategies and messaging are most appropriate to engage the intended audience, while also adhering to Federal Regulations and institutional policies and guidance.

Before identified potential participants can be recruited engagement must happen. Engagement, in this sense, is about delivering content to the right person, at the right time, with the right frequency, through the most effective channel.

True stakeholder engagement should happen as early in the study design process as possible. However, that’s not always an option when Duke is a participating site in “someone else’s research study” – when this is the case, we think of engagement as the strategies used to share information about a study with potential participants. This may include one or more of the following channels:

• Duke Health Research Volunteer Registry
• ResearchMatch
• Social media (e.g., Facebook ads)
• Print media (e.g., flyers, brochures, etc.)
• Online/digital content (e.g., a study website or search engine ads)
• Radio or TV spots
• Letters or emails
• Phone scripts for personal phone calls
• MyChart messages

Advertising, regardless of the chosen channel(s), must follow federal regulations, Duke policies, and Duke branding requirements. Links below provide information about allowable typography, colors, use of logos, and additional tools.

• DUHS Brand Center
• School of Medicine Brand Guidelines
• Duke University Brand Guide
• DUHS Policy and Guidelines for Advertising Research
• DOCR Social Media Recruitment SOP

Discover Duke Research 

The Recruitment Innovation Center manages the Discover Duke Research Facebook and Instagram pages and offers free social media marketing consults to all Duke research teams. During a social media marketing consult, the RIC team and investigator will work together to begin drafting a social media marketing plan to submit to the IRB for approval. Ads can be launched by the RIC from the Discover Duke Research accounts (Facebook/Instagram, Reddit, and Google) or the investigator may launch them from another approved social media channel per the Duke Social Media Recruitment SOP . RIC services (e.g., assisting in the development of a social media marketing plan, acquiring high quality images for advertising, managing the campaign, etc.,) are free of charge but there is a fee for the ads themselves.

• Request a  social media marketing consult .
• Review other available Policies, Procedures and Guidance in the "Related Resources" section of this page.

Duke Health Clinical Trials Directory 

The Recruitment Innovation Center manages content on the Duke Health Clinical Trials Directory . Reviewing the SIP Console Training in LMS (course #00129901) is recommended before reaching out to the RIC for assistance ( [email protected] ) in having a study posted on the Directory.

Engagement, recruitment and retention planning should take into consideration best practices for literacy, numeracy, and health literacy as well as principles of good readability. Principles of readability and tailoring to the health literacy needs of a population include adherence to the following principles:

• Responsibility : Clear research communication is the responsibility of all stakeholders in the research enterprise
• Life Cycle Adherence : All research communication should be clear and easy to comprehend throughout the research life cycle
• Partnership : Research communication should be developed in partnership with the intended audience(s)
• Cultural Sensitivity and Respect : are integral to clear communication about research
• Tailoring : Research materials for participants should integrate literacy and health literacy practices, including plain language, numeracy, visualization and design techniques, and cultural considerations
• Evaluation : Participant research materials should be evaluated to ensure the intended audience can understand the information
• Confirmation : In-person communication should encourage dialogue and confirm understanding
• Institutional Support : All stakeholders in the institutional research enterprise should support the development and implementation of organization policies that integrate literacy, numeracy and principles of good readability

Engagement, Recruitment, and Retention Certificate Program

The Engagement, Recruitment, and Retention Certificate Program is a certificate and skills-building program designed for Clinical Research study teams. The intention of the program is to help staff develop and expand competency in participant engagement, recruitment, and retention.

Participant Retention Strategies

Good retention starts with a strong, feasible, well-considered engagement and recruitment plan and a participant-centered research study. Many a study has been derailed by inadequate attention to recruitment and retention barriers and lack of effective strategies to overcome them.

Approaching recruitment and retention by ensuring a protocol is participant-centered will enhance the chances of a successfully completed study that finishes enrollment on time with a strong retention rate. Being participant-centered requires an investigator to consider every element of the project from the perspective of a participant and a variety of other characteristics (e.g., relevance of the study question to them, motivation - altruism, compensation, access to novel therapy, etc. - disease state, therapeutic options and opportunity costs, etc.). Adopting both a participant-focus and a quality-by-design framework can help examine study objectives and identify the factors that are critical to achieving them, while minimizing the burden of participation for participants. In terms of recruitment and retention, this should (at minimum) include attention to the following:

• Eligibility criteria – each criterion should be reviewed for its importance to achieving the study aims, its effect on the availability of the population and its acceptability to providers, participants and (if applicable) patient advocacy organizations.
• Accrual feasibility – does the study population as described actually exist? Is there one (or more) particular criteria that will weed out a large number of potential participants? Are there adjustments to the eligibility criteria that should be made?
• Adequate compensation – not all studies have the option of compensating participants. However, it’s important to consider the time, effort and hassle participants are enduring to take part in a study. Compensation in the form of money, expense reimbursement (e.g., travel, parking, meals), meaningful/useful tchotchkes or give-aways, etc., are all appropriate methods of compensating participants.
• Study procedures and event schedules – are the study procedures, including their invasiveness and risks, length and frequency of visits and location of participation particularly burdensome for the target population?
• Feasibility in the clinic – examine the study from the perspective of providers and clinic staff and their daily clinic operations. Will the study impact their clinic workflow? Engage them early in study design to mitigate against this risk; otherwise, ensure flexibility to minimize disruption.
• Reducing the burden of participation – research participants are often busy people, deeply embedded in dynamic personal lives. A research study is not part of their job. Providing flexible appointment times, short visits, and convenient locations for in-person study visits can ensure that it’s easy for participants to remain in a study. Consolidate visits when possible and provide “remote” options when feasible.
• Clear, frequent communication – Well-timed communication, including study visit reminders, via participant-preferred methods (SMS, email, phone call), an updated website, newsletters about study progress and milestones achieved, etc. are all good ways to keep participants engaged and interested in a study. Lay summaries of findings can be useful, especially if an abstract or a poster about the project is published.
• An attitude of humble gratitude – People are not required to participate in research. Their participation is a gift to be appreciated. Frequent communication of gratitude and recognition of the time and effort participants are sharing is often cited by participants as important to their continued participation. A commitment to providing a lay-summary of the study results at the end of the study is a great way to demonstrate appreciation and turn research participants into research evangelists.

Through Innovation, Connections, Collaborations and Education, the Recruitment Innovation Center is available to help with recruitment needs. For assistance and support across the enterprise, reach out to the RIC at [email protected] or request a consult today.

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5 best recruitment strategies for clinical trials

• 85% of all clinical trials fail to recruit sufficient patients, and 80% delay due to recruitment challenges.
• Understand patient needs
• Build relevant connections in the health community
• Partner with the right recruitment firm
• Create an effective digital recruitment campaign
• Effectively follow up with trial participants
• With RingCentral, researchers can establish the links they need to recruit the right participants and retain them until the end of the trial.

🧑‍🔬👨🏻‍💻🚀 Patient recruitment can benefit significantly from digital solutions. Read our checklist that trial administrators can use to deploy the right technologies.

If you are a medical researcher, you know all too well about the costly, complicated, and time-intensive process of bringing a new drug to market. To put it into perspective, the world’s tallest structure, the Burj Khalifa in Dubai, only cost constructors half the money required to deliver new medicine to patients. Pushing the cost of success even higher is the fact that 90% of all test drugs that reach trial stages never get approved.

“ The biggest category of spending in R&D is clinical trials, and most of the money spent on trials goes toward programs that fail .”

—Rob Lenz, Head of Global Development at Amgen Inc.

At first glance, you might think this alarming failure rate is entirely due to stringent measures by regulators like the FDA. However, a detailed analysis of clinical research programs reveals financing and patient recruitment as significant hurdles.

• 22% of trials that fail Phase 3 studies cite inadequate funding as the main reason.
• 20% of failed cancer trials report struggling with patient recruitment.
• 85% of all trials fail to recruit enough patients.
• 80% of trials delay due to recruitment challenges.

Although financing problems may be out of their control, trial managers can do quite a lot to enhance recruitment. With 40% of the total research budget going to patient acquisition, refining enrollment can also help save costs and mitigate funding challenges.

Thank you for your interest in RingCentral.

Clinical trial recruitment strategies

Here are five clinical trial recruitment strategies designed to help trials meet their objectives and connect patients with the right treatment opportunities.

In summary, clinical trials must:

• Properly understand patient needs and preferences before starting recruitment.
• Connect with local healthcare providers, non-profit organizations, and patient advocates.
• Partner with a patient-focused recruitment company that insists on diversity in outreach.
• Create an effective digital recruitment campaign.
• Reinforce follow-up services.

1. Properly understand patient needs and preferences before starting recruitment

Patient voice must be the foundation of any clinical study. A trial cannot attract the right participants if it lacks the endpoints that are relevant to them. Therefore, as a researcher, you must start by asking the right questions to understand what your target patients need and expect from your trial.

For instance, industry statistics show that patients living with chronic conditions are less likely to participate in new drug trials than acute patients. Because finding the right treatment for chronic conditions like lupus and Alzheimer’s Disease can take time, chronic patients are often less interested in trying something new than acute patients.

In trials for long-lasting ailments, potential participants need a clear presentation of the benefits of joining and how the outcomes may improve currently available treatments.

Similarly, trials that require either in-clinic or in-home patient care are typically less attractive to patients than those which only need occasional visitation because they offer limited flexibility. If your trial requires close monitoring, you must carefully highlight the convenience you offer, such as video conference options and flexible scheduling.

Patients will be more inclined to join your trial if you demonstrate a proper understanding of their needs from the beginning.

2. Connect with local healthcare providers, non-profit organizations, and patient advocates

A CISCRP survey reveals that 64% of patients prefer hearing about a trial from their healthcare provider rather than a third party. So, when starting your recruitment drive, the proper approach is to connect with prospective participants through their primary caregivers.

Consider developing outreach materials specifically for doctors and leveraging any relationships you may have with local hospitals to promote your trial. That way, patients will view your study as more of a recommendation from their caregiver rather than a mere advertisement.

Besides practitioners, you can also partner with non-profit organizations and patient advocacy groups to increase visibility. Collaborating with these organizations can help add a layer of credibility to your trial and give patients a sense of security about their participation.

3. Partner with a patient-focused recruitment company that insists on diversity in outreach

Any clinical trial must have diversity at the forefront of its outreach strategy. Differences in gender, genetics, age, weight, race, and even location can influence treatment efficacy and safety. Without a diverse group of participants, trial outcomes might fail to identify critical performance variations across different demographics.

When evaluating whether a recruitment company can adequately meet the diversity requirement, prepare questions that get to the heart of the firm’s activities.

• Do its outreach materials reflect the entire patient population?
• Does it use a wide range of different approaches to reach and recruit patients?
• Is it using technology to map and track diversity accurately using pre-determined metrics?
• Does it have a diverse team of recruiters?
• Is it well connected to patient advocates or other community groups?

Gauging a company’s ability to recruit diverse participants can help you pick the partner that will maximize your trial’s chances of success.

4. Create an effective digital recruitment campaign

Online marketing methods like digital ads and social media campaigns can be highly effective in reaching patients beyond health databases and connecting with them in their most preferred way.

Social media attracts 3.5 billion users at any given time, making it the ultimate tool for engaging potential trial participants. With minimal time and effort, you can get your message to the masses and reach a good number of patients.

Interest and keyword targeting can also enable you to find patients actively looking for treatment options and most likely to sign up for your trial.

5. Reinforce follow-up services

Your trial may constantly be on your mind, but it could just be one more notification on patients’ phones. Without effective follow-ups, your texts and emails risk being overlooked or forgotten.

While automated notifications can be effective at reminding patients to take the next step in the trial, a comprehensive engagement approach is more desirable. Patients have numerous communication options at their disposal, from phone calls and emails to online chats and social media.

Therefore, it is essential to apply communication strategies that accommodate all channels. Data analytics can also help log the platforms a particular patient uses the most. With this insight, you can create tailored engagements and maximize response rates.

Reinforce your patient recruitment strategy with RingCentral 

In clinical trials, a successful recruitment process hinges on the researchers’ ability to understand patient needs, build relevant connections in the health community, partner with a capable recruitment firm, create an effective digital recruitment campaign, and effectively follow up with trial participants. At the heart of these five pillars is the right communications platform.   

RingCentral delivers all necessary channels on one cloud-based platform, enabling your team to engage with relevant parties, be they patients, healthcare providers, advocates, non-profit organizations, or recruitment companies, as seamlessly and cost-effectively as possible. With RingCentral’s modern and secure cloud communications, you can establish the links you need to recruit the right participants and retain them until the end of your trial.

Reach out to a RingCentral expert today to help you refine your patient recruitment process and achieve stellar results.

Originally published Dec 02, 2021, updated Feb 10, 2022

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Recruitment Strategies for Clinical Trials That Work

Clinical trial recruitment can be a significant barrier to trial success. 

Some researchers estimate upwards of 90 percent of clinical trials fail to recruit the required number of study participants causing nearly the same proportion of trials to become delayed, costing study sponsors enormous amounts of time and money. 

High patient dropout and poor retention rates combined with these dreary statistics make optimizing a trial’s recruitment strategy a high priority.

Set Up Your Trial for Success 

Proactive study decision-making can affect the success of a clinical trial immensely. Certain decisions, such as picking the proper sites or the number of expected participants from each site, can affect downstream efforts from the study sponsor and the sites themselves. 

Additionally, successful studies have a realistic enrollment time estimate by allowing for inevitable enrollment problems in the proposed timeline. 

Improper protocol design is another disastrous facet of clinical trial failure and can derail a study before it even begins. Additionally, attempting to perform a study in an area with direct competition with other studies’ recruitment efforts can contribute to study failure. 

After we set up our trial for success, what strategies can we take to overcome recruitment challenges? What considerations can we make beforehand to lessen the recruitment burden? Here are a few ways to set your trial up for success before recruitment:

What Are the Top Five Ways To Optimize Trial Recruitment?

There are several methods commonly used to recruit patients. The most successful recruitment tactics involve clear communication and convenience. Let’s look at the best ways to optimize trial recruitment below.

#1: Understand the Needs of the Patient

The best way to optimize your recruitment efforts is to develop a patient-centric protocol to ensure the patient is prioritized throughout the study. 

Not only will this help with initial recruitment, but patients who feel their needs are being appropriately acknowledged and addressed are more likely to remain in a study. 

Developing a patient-centric protocol can be a multifaceted approach. From the beginning, creating recruitment materials directed toward the patient can grab their attention immediately. 

Attractive emails or directly mailing study information can grab a potential study participant’s attention immediately.

Provide Accessible Information

Providing easy-to-read study information at a health literacy level appropriate for the target study population (usually a fourth to sixth-grade reading level) can go a long way toward promoting study comprehension. 

Some successfully recruited studies employ an additional educational session, such as a brief telephone conversation, to educate the participant about the trial’s purpose.

Other commonly implemented recruitment strategies such as producing flyers, brochures, newspaper ads, and billboards can also be effective. Once again, knowing the target audience for these strategies is essential. 

For example, young adults between 18 to 24 are unlikely to interact with a physical newspaper, similar to elderly adults over 70 coming across a social media advertisement. 

Recruitment materials should also be geographically and culturally appropriate . If the study aims to recruit in another non-English speaking country, the materials must be translated appropriately into the local language.

Encourage Family and Community Support

Family members are often patients’ core support members. Without the moral, and sometimes literal, support from family, patients become much less likely to make appointments and adhere to prescribed medications, let alone participate in a clinical trial. 

Another way to involve a different kind of family is through community outreach. Studies have shown that support from the community can be just as beneficial to patient satisfaction in a study as their biological family.

Consistent Feedback Is Key

Finally, constant feedback during the trial can tremendously improve participant retention and overall satisfaction. Consistent check-in and evaluation without being invasive can help study participants once again feel their inclusion in the study is appreciated. 

#2: Utilize Referrals

A referral system is one of the best ways to improve clinical trial recruitment while saving money. Patients often prefer to hear about a trial from their healthcare provider instead of a third party. 

The most effective approach to connect with prospective participants is through their primary caregivers. 

When a patient’s healthcare provider offers the opportunity to participate in a study, the offer comes off less as an advertisement and more as a chance to participate in research that can benefit not only themselves but other patients with similar medical problems. 

Research suggests the majority of the general public prefers to hear about a study from their primary care provider, but very few studies recruit this way. Establishing a network of providers is a low-cost, effective way to reach patients in a way they trust. 

#3: Implement Technology

In today’s society, it would be a missed opportunity not to implement digital advertising to support clinical trial recruitment. 

Physical media, such as flyers, brochures, and newspaper ads, have now become an expensive advertising option compared to digital advertising online. Even other audiovisual media formats such as television and radio cost more per advertisement and reach fewer potential study participants. 

Social media, in particular, reaches billions of people at any given time. No other media format even comes close to how widespread and accessible social media has become. 

Implementing keyword targeting and advertising on sites most likely to reach the target study audience are two great ways to utilize social media to your advantage. 

#4: Provide Incentives

Incentives are a commonly used, effective tactic to recruit participants for clinical trials. Study participants often wonder what is in it for them when volunteering for a study. 

Outside of furthering our clinical knowledge through responsible research, it can be challenging to incentivize participants properly. While some studies have shown that altruism is the most effective motivator to participate in research, study participants enjoy incentives that make them feel like their time in a study is appreciated. 

Incentives do not have to be monetary, either. Other options include transportation to and from study appointments, hotel accommodations, and food and drink. 

Ultimately, making a participant’s involvement in a study as easy as possible will benefit recruitment and retention. 

#5: Don’t Forget About Patient Retention

Even with the most successful recruitment tactic, no study can succeed without adequate patient retention. Despite this, many studies fail to factor in just how vital retention can be. 

While many of the previously mentioned recruitment strategies, such as family involvement and incentives at follow-up visits, can also be applied to support retention, there are additional schemes sponsors can employ.

Patient engagement can dramatically increase retention. Besides essential follow-up visits and phone calls, a more comprehensive and patient-centric approach to follow-up can be beneficial. 

Knowing the patient population and the intervention or disease state being investigated can point study sponsors in the right direction. 

For example, in a study of young adults 18 to 24, implementing an online chat service to discuss study concerns can effectively engage the target population. In addition to consistent participant check-in during the study, it can also be helpful to self-evaluate how the study is going. 

Regular check-in and self-assessment during the recruitment phase can prove just as valuable as planning. Tracking site study participation closely can give study sponsors more insight into enrollment and retention. 

Sometimes the decision has to be made to close or terminate study recruitment at a site early if the site is not on track. Doing so can limit valuable resource loss at locations that may not perform as well as others. 

BONUS: Partner With a Clinical Research Organization (CRO)

Clinical Research Organizations (CRO) can be immensely helpful in orchestrating a clinical trial. CROs can considerably improve a clinical trial’s efficiency, scalability, and overall success. 

While utilizing a CRO is an investment, some CROs can provide global clinical trial support and expertise in pharmaceuticals, biotechnology, and medical devices that can prove invaluable.

CROs can help navigate some of the problems and considerations previously discussed, such as regulatory concerns and protocol optimization. 

At iProcess Global Research , you can expect exceptional teams and operations to provide cutting-edge research to help organizations with clinical trials. 

With a constant demand for clinical trials, iProcess continues to meet the demand for specialists who can provide the high quality and competence required to facilitate clinical trial recruitment for success.

Sources: 

Effectiveness of Participant Recruitment Strategies for Critical Care Trials: A Systematic Review and Narrative Synthesis | SagePub

How to Optimize Patient Recruitment | PMC

Optimizing Clinical Trials Recruitment via Deep Learning | NIH

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Study Advertisement Resources

UR CTSI recruitment and retention experts have curated a set of resources that researchers can use to develop advertisements for their studies. If you're looking for more support, our experts can consult with you, provide feedback on recruitment materials, and help assess your overall marketing strategy. We can also guide you on how to create and run some forms of paid digital advertising (social media, search, or banner/display). Please schedule a Recruitment Consultation .

Documents and Templates

• Video: Volunteer for Health Research – This three-minute video includes testimonials from several study participants about why it is important to get involved in health research.
• Doctor to Doctor Letter – This document can be used to introduce a study to a physician and to ask them to refer patients to your study for enrollment.

Flyer Templates on Canva

The UR CTSI and URMC Marketing have created several flyer templates with UR branding to make it easy for researchers to design a study flyer. Researchers will need to create a free Canva account to access the templates. To get started, follow the link below, scroll through and choose one of the templates, and click on the areas you want to edit. When you are finished editing your flyer, click File > Download to save it.

UR-Branded Study Flyer Templates

UR Health Research Marketing Materials

The UR CTSI and URMC Marketing team have developed a set of downloadable marketing materials to encourage participation in health research. These materials, including a brochure, flyer, several posters and examples of social media ads, offer the UR Health Research website as a resource to learn more and get involved in studies. Feel free to share these items with your patients or the community or use them as inspiration to design your own ads.

UR Health Research Marketing Toolkit

Where to Find Free Images

The websites below offer free images that you may use in your ads. Always be sure to comply with copyright restrictions .

• CDC - Public Health Image Library
• National Cancer Institute Visuals Online
• Library of Congress Photos on flickr
• The Noun Project
• Flickr Creative Commons Search
• Centre for Aging Better

Guides and Toolkits

Recruitment innovation center toolkit.

The Recruitment Innovation Center at Vanderbilt University is an evidence-based center in innovative multi-site trial recruitment and retention methods, tools and strategies. Their published Recruitment and Retention Toolkit is a resource for research teams to utilize for creating participant recruitment and retention materials and materials for clinician awareness/study referrals. Other recruitment and retention resources can be found in the Trial Innovation Network Toolbox .

Antidote.me

This guide from Antidote.me provides tips about different forms of advertising and when to use them. It contains helpful information you need to kick off a successful clinical trial advertising campaign. How-to Guide for Advertising

Advarra Tips for Patient Recruitment

Advarra has many articles related to the topics of recruitment and retention. Patient enrollment and retention

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15 clinical trial patient recruitment companies (and how to choose one).

Updated July 2022: 

Clinical trial patient recruitment companies make use of many methods, including digital advertising and community partnerships, to find the right patients for your trial. Depending on the trial your organization is running, it may be advantageous to pick a company that has a specialized focus in a therapeutic area or patient population. You may want to also consider finding a company that offers multiple services in addition to patient recruitment, such as custom prescreeners or site identification. 

When it comes to picking your recruitment partner, make sure to think through each company’s offerings and experience in the area you will be researching. Below, we have included some questions to ask a potential vendor, in addition to an overview of how clinical trial recruitment companies can help solve common challenges involved with finding study participants.

15 clinical trial patient recruitment companies

These 15 clinical trial recruitment companies are some of the best in the business. Read a bit about each to determine who is the ideal fit for implementing clinical trial recruitment strategies for your organization.

• Antidote : Antidote’s mission is to connect sponsors and research sites with informed, engaged patients who are interested in participating in a clinical trial. Services include validated referrals, customized outreach plans, access to a 300+ nonprofit and patient advocacy partner network , and other premium services for trial sponsors.
• AutoCruitment : AutoCruitment makes use of more than 1,500 digital channels to connect with patients searching for medical information online. It is also known for its speed and advertises a three-day setup time.
• BBK Worldwide : With over 30 years of experience in patient recruitment, BBK Worldwide has a vast library of whitepapers and ebooks to share what they have learned throughout the years. 
• Clariness : Clariness is an internationally focused recruitment company that has enrolled patients in more than 1,000 trials in 50 countries .
• ClinicalConnection : ClinicalConnection works with a database of patients and also features study centers on the website for potential participants to find.
• CSSi : As part of their patient recruitment strategy, CSSi connects with local patient organizations to find eligible participants.
• Curavit : With decentralized clinical trial execution, Curavit specializes in connecting with patients via telehealth and trial technology platforms.
• Elligo Health Research : Elligo Health Research has a time-tested “Elligo Direct” approach that makes it simple for physicians and their patients to take part in clinical trials.
• Langland : An advertising agency with branding and clinical trial marketing expertise, Langland is able to blend patient, protocol, disease, and media insights with data and technology to provide recruitment and retention solutions.
• MMG : With several decades worth of experience, MMG refers to itself as a team of global recruitment strategists and emphasizes its strategy support capabilities.
• Praxis : By offering a range of service options , Praxis allows customers to pick and choose what they need, from digital advertising to community outreach.
• Science37 : A technology-focused company, Science37 is a virtual clinical trials company that can provide full trial execution or supplemental technology in addition to change management services.
• StudyKik : After seeing advertising for the service across Facebook and other platforms, potential participants can sign up for Studykik and be notified when a trial is created for which they may be eligible.
• TrialSpark : By partnering with physicians and pharmaceutical companies, TrialSpark reduces the time and expense of clinical trials by providing technology, equipment, and staffing.
• TrialX : In addition to patient recruitment services, TrialX also creates mobile apps for trials.

What to consider before choosing a clinical trial recruitment company

When picking a company for clinical trial recruitment, be sure to consider what each one offers and their experience in your specific therapeutic area. Below, we have listed some questions that companies can ask themselves to determine which clinical trial recruitment partner is right for them .

Do you need help picking site locations for the trial? If you have not yet decided on the site locations for your trial, it may be helpful to consider working with a company that will assist with this part of the process. Many companies can use data from previous trials to identify the best locations and have a deeper understanding of ones that might prove difficult in terms of recruitment.

Are you proactively seeking recruitment support, or are you looking for “rescue” recruitment? Some companies specialize in recruitment support for specific parts of a trial. If your trial has already begun and has failed to achieve good patient enrollment numbers, a company that focuses on speed and efficiency may be ideal . If you’re proactively looking for assistance, you will likely be better off choosing a company that can provide strategic planning and guidance for the full breadth of the trial. What budget model are you looking for in the trial? There are a range of budget options offered by clinical trial recruitment companies, such as paying for performance or negotiating a flat fee. It’s smart to think through your trial’s budget and how you want to structure your payments so you can discuss this with potential vendors. Does the company have an in-house marketing team? Collaborating with a company that has an experienced, internal marketing team is a great way to get online advertisements that stand out among cluttered social media and digital feeds. When you talk to potential companies, it’s smart to ask how they develop their marketing materials and if you can review previous campaigns they have run .

Does this company have experience in my therapeutic area? Location, inclusion criteria, and the protocols of a trial can heavily influence participation rates, but if a company has recruited in a specific area before, they should have a good sense of what tactics do and don’t work for recruiting in a certain space. Working with a company that has operated in your therapeutic area before can give you access to these vital insights, and you can often ask for case studies to see examples of their past results .

Does the company specialize in a particular phase of trials? Some recruitment companies will have expertise in specific phases of clinical trials , which can be helpful depending on your needs. Depending on what phase your trial is at, choosing a company experienced with healthy Phase 1 volunteers can be ideal, while companies experienced with Phase 4 can be great if you need ongoing research and observation.

Has this company worked on international trials before? If you are using trial sites in multiple countries, it can be helpful to work with a recruitment company with international experience. This can be useful if you need translated materials or assistance creating ad strategies to recruit non-U.S. participants.

How does this company handle ineligible patients that may be able to participate in my other trials? Some recruitment companies maintain a database of patients that have shown interest in trial participation and can recruit from that database. For example, at Antidote, we offer the option to match patients from our database with any trial in your portfolio so potential participants are not lost in the shuffle. 

What is the lead time for developing materials and a recruitment strategy? Many companies will advertise their recruitment speeds to potential customers, so if you are on a tight deadline, this can be helpful for getting things started in a timely manner. 

How will patients be screened? Some recruitment companies can also handle creating and hosting a custom prescreener for your trial, in addition to executing patient phone screening. It’s helpful to think through whether or not you would find these services useful when choosing a recruitment partner.

How does the company handle lackluster recruitment results? There are many challenges surrounding clinical trial recruitment, and roadblocks to patient enrollment are common. Inquiring about how the company handles these challenges can let you know how to expect them to amend their strategy if recruitment isn’t going as well as they had hoped.

Am I looking for both patient recruitment and retention? Once a patient is enrolled in your trial, it is important to consider what effort will be made to retain them. Some recruitment companies provide services designed to help your trial continue running on schedule, even after the recruitment goal is reached. Tools can range from engagement programs to technology that assists with collecting patient data to follow-up services at the site.

What types of reporting would you like to receive from the company? When in talks with your potential vendor, it can be wise to ask how often they update clients on recruitment metrics and any other insights into the campaign’s performance. Often, you can request a sample report to review what the company typically shares with its clients and how often.

What is the company’s relationship with patients? Patient centricity starts with the initial research design and continues to be important throughout a trial. Inquire with potential vendors on any feedback they’ve received from patients on advertising campaigns or other elements of the recruitment process. It is smart to look for a company that is focused on creating patient materials that are clear, readable, and contain essential information to help patients determine if the trial is a good fit.

What diversity efforts are involved in patient recruitment? It is important that clinical trials accurately reflect the population, so making efforts toward recruiting a diverse and varied population is a key consideration. Talk with potential vendors about how they are approaching diversity initiatives , especially if your therapeutic area disproportionately impacts a certain patient population.

How does the company find patients to participate? Recruitment vendors have a whole host of techniques at their disposal to find patients (see below), but your organization may also have a preference for how patients are engaged. For example, if you are doing research surrounding a rare disease, it may be beneficial to work with a company that has partnerships with organizations that focus on that condition. When assessing a company, be sure to ask questions about what approaches they have found most effective.

Clinical trial patient recruitment challenges

Patient recruitment companies can help solve common challenges that are often encountered during a recruiting campaign. Whether you approach a recruitment company before you begin trial recruitment or utilize them for a "rescue study," they can be great resources for handling these challenges — and having a general understanding of how to recruit patients for clinical trials can help you be sure you’re asking the right questions when meeting with potential vendors.

Challenge: You’re getting referrals for patients that aren't eligible for the trial.

Solution: Diversify your patient recruitment approach.

Nearly 85% of clinical trials struggle to recruit enough patients , and some fail to enroll a single patient. Unforeseen issues, such as inaccurate patient data or competition from other nearby clinical trials, can pop up even with an effective site selection process in place.

By diversifying your approach to patient recruitment early on in the process, you can set your trial up to reach (or even beat!) its recruitment timelines. Working with a clinical trial patient recruitment company can be beneficial even before a trial has begun to fall behind.

Challenge: Research sites are underperforming.

Solution: Collaborate with a recruitment company with access to specific and accurate data.

As medical knowledge has developed, clinical trials have become more complex. For example, many researchers require participants to have specific lab values or markers, which is information patients often do not know on their own. Specifics like this can often result in more screenfailing of patients, which can lead to recruitment delays.

One way to tackle the issue of complex eligibility requirements is by working with a recruitment company that has patient data that reaches beyond a diagnosis. Patient medication, results from recent bloodwork, and other key markers can give researchers valuable insights into the likelihood of a patient’s eligibility. For example, key partnerships such as Antidote partnering with PWN allow us to provide trial sponsors with lab-validated patient referrals.

Challenge: Patients become unresponsive before they ever reach your research sites.

Solution: Get support on patient and site follow-up.

Even for patients who are very interested in participating in a clinical trial, there are plenty of factors that can result in a loss of contact. Missed communications, a lack of availability for screening, and other issues can result in your trial losing the patient between initial contact to randomization.

Contacting interested patients and performing site screenings keep trial staff busy as is, so finding time to follow up with patients who have disengaged often falls by the wayside. A recruitment agency can often provide site and patient follow-up services, which can help retain patients and move them to the next step in the screening. Automated follow-ups and rescheduling opportunities can reduce site time and move patients forward in the process, in addition to obtaining valuable information if the patient’s cancellation was intentional.

Challenge: The patients you find live too far from your sites.

Solution: Offer travel services and adjust your targeting.

There are several things that will impact how far study participants are willing to travel to participate in a trial, such as the frequency of visits and how symptoms impact a patient’s mobility. If you are finding patients that live too far away from your research sites, the first thing to do is to get in touch with the site or recruitment company conducting your outreach to see if you can reduce the radius of your targeting. You may also want to consider providing travel services or reimbursement for patients that do live farther away in order to better incentivize their participation.

Challenge: There is a lack of interest in your trial, even after outreach efforts are made.

Solution: Collaborate with a recruitment company that has more experience with the condition you are researching.

While every patient is different, the research that has been conducted on clinical trial participation can show us some common themes. Patients are generally motivated towards trial participation as a way to give back and help research, but in a patient survey Antidote conducted, it was revealed that motivations can vary widely depending on the condition in question. For example, we found that asthma and allergy patients rated receiving payment as influential in their decision to participate. 

If your current outreach methods are not leading to strong participation numbers, it may be because the interests of your patient population are not being reflected. Working with a company that has experience recruiting for a range of conditions can ensure you are distributing effective outreach materials that resonate with patients who have specific reasons to be interested in participating in a clinical trial.

What clinical trial recruitment strategies do agencies use?

Finding the right patients to participate in research typically requires the use of multiple clinical trial recruitment strategies . Some recruitment providers may specialize in a specific approach, but most companies will employ an array of strategies to connect with patients . The clinical trial recruitment process may include:

Digital advertising: Utilizing Google Ads, Facebook, and other social media ad platforms allows recruiters to target users with specific interests that relate to a trial’s inclusion criteria, in addition to targeting people who are searching for clinical trial opportunities. Additionally, website ad placements allow a company to target users based on the pages they are visiting, which may indicate their interest in a clinical trial.

Traditional advertising: Traditional ad placements can range from radio ads to billboards to print materials distributed at doctor’s offices.

Patient databases and registries: Some clinical trial recruitment companies maintain a database of patients who have shown interest in clinical trial participation and can alert patients when there is a trial in their area that may be a good fit. Not only does this benefit your trial by increasing its potential reach, but companies that have these databases often offer a lower cost-per-patient price compared to the companies that are doing all of their outreach from scratch.

Partnerships: Clinical trial recruitment companies may have partnerships with nonprofits and community groups that are associated with a particular condition, which can be especially helpful when these partners have robust email lists. By leveraging these partnerships, recruitment companies can reach a group of motivated, qualified patients in a streamlined way.

Electronic Health Record (EHR) matching: There are companies that offer software to integrate medical record review into recruitment, which is beneficial for several reasons. Because health records often indicate lab tests, recent treatments, and more, EHR matching can make it easier to identify patients who may be eligible for the trial. It also allows physicians to easily alert their patients about potential clinical trial opportunities — plus, if patients have heard about the trial from a trusted source, such as their doctor, they may be more likely to show interest in participating.

Community events: Companies that have partnerships with nonprofits and other organizations will often attend local health fairs or other related events and can promote your trial there via flyers, pamphlets, and other advertising materials.

Learn about how Antidote has helped sponsors connect with our community of patients by downloading our case studies.

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Strategies to Close the Gap in Clinical Trial Recruitment

2021 survey highlights challenges and opportunities for investigators, coordinators, and patients.

Sharon Karlsberg

Cathy Zeanah

The past two years have underscored the value clinical trials can bring to global healthcare yet sponsors and investigators continue to face challenges in fulfilling enrollment quotas.Investigators frequently cite identifying and enrolling eligible and interested patients as the area of greatest need for improvement in the clinical research process, particularly when trying to recruit a diverse and representative sample. However, ZS research found that patients are more open to clinical trials than many investigators assume. Additionally, we found that the way trials are presented—and by whom—can increase motivation to participate.

In custom Voice of Site and Voice of Patient (VOSP) research conducted last spring, ZS surveyed over 430 US respondents, including principal investigators (PIs), clinical research coordinators (CRCs) and prospective and experienced clinical trial patients across therapeutic areas. The goal was to learn about challenges and opportunities related to clinical trial recruitment and experience, particularly within historically underrepresented patient communities.

Opportunity #1: Avoiding assumptions and implicit biases about who is interested in trials

One of the most surprising findings in our research was just how willing patients are to participate in a clinical trial relative to PI expectations, even among underrepresented patients. Seventy-five percent (75%) of all patients surveyed told us they were interested in participating in a trial if recommended by their doctor, while seventy-seven percent (77%) of underrepresented patients were willing.

In contrast, investigators on average offer clinical trials to less than half (44%) of clinically eligible patients. What’s behind the gap? PIs cite concerns with schedule compliance, drug compliance, or health literacy as contributing factors. PIs further assume that only 45% of patients offered a trial would be interested.

This pre-screening based on assumed interest and ability to complete a trial significantly reduces potential trial populations. ZS’s Study of Underrepresented Patients for Equity in Recruiting (SUPER) reiterated the risks of making assumptions related to health literacy. For Black and Hispanic patients with breast cancer, for example, willingness to participate increased by 25% when the research study was described in clinically accurate, detailed language versus simpler language. Including less detail actually decreased BIPOC ( Black, indigenous and people of color ) patients’ willingness to join a trial, reinforcing the notion that talking down to patients can hinder recruitment efforts.

Strategies for avoiding assumptions

By offering clinical trial opportunities to many more patients and ensuring support to address logistical and educational needs, sponsors and sites can significantly expand the top of the funnel. Sponsors should identify potential implicit biases at play in recruitment and work with sites to implement more objective pre-screening approaches that can circumvent the opportunity for bias to influence who is offered a clinical trial. Study sponsors would do well to reconsider assumptions about language used in clinical trial materials to ensure that patients who seek out more technical information are able to access that detail.

Opportunity #2: Conveying ‘what’s in it for me’ (WIIFM)

The majority of patients interested in participating in clinical trials were motivated by a personal benefit. Sometimes this benefit was access to treatment at no cost, but patients were motivated just as often by more experience-related benefits. Seventy-three percent (73%) of patients cited the opportunity to be treated by experts who focus on their disease as a motivating factor; sixty percent (60%) noted the opportunity to receive additional care and attention from clinic staff and fifty one percent (51%) highlighted the opportunity to learn more about their own health. These findings are consistent across racial and ethnicity groups and were reinforced by trial-experienced patients who often cited the care and attention from staff, as well as ability to learn about themselves, as top reasons for a satisfactory experience. Patients who were more satisfied with their study experience often recalled direct interactions with the PI and research coordinator rather than only the trial nurse, highlighting the importance of maintaining a human touch even as clinical trials become more digital and decentralized.

Compared to patients, our findings uncovered dramatically different motivating factors for investigators who conduct trials. Two-thirds of PIs are driven by their ability to contribute to advancement of medicine and population-level benefits. Additionally, PIs tend to be less comfortable discussing potential patient benefits in a trial than speaking about more altruistic motivations, such as helping others. Raising awareness of these different “WIIFMs,” and helping investigators bridge the gap by communicating more in terms of patient benefit, could help drive greater and broader patient interest in participation.

Strategies for conveying ‘what’s in it for me’

Sponsors can help ensure the right resources are available to provide a positive patient experience throughout the clinical trial journey. That can include ensuring there’s a connection to experts; demonstrating high levels of care and attention; exhibiting strong communication throughout; and minimizing study burden. Beyond setting up these experiences, it’s important to make patients aware of what to expect upfront to increase their comfort in participating.Sponsors may consider if other roles such, as a coordinator, may be more comfortable talking to these experience-related benefits than some investigators.

Opportunity #3: Leverage trusted relationships to recruit and retain patients

Gaining the trust of potential trial participants is essential for enrollment and retention in general, but increasingly so for historically underrepresented groups. Distrust and fear are often on the minds of Black and Hispanic patients, even if they are willing to consider trials based on personal benefit. Patients in these groups shared reasons for lower participation rates, such as:

• “Because we are scared that we are going to be experimented on.”
• “BIPOC folks have a long history of being used and manipulated by research so it is difficult to trust.”
• “People of color face a lot of medical discrimination.”

Thus, while conveying WIIFM is a starting point, it’s also important to keep in mind who is delivering the message. When we asked patients to compare their comfort level with different profiles of potential investigators, the responses were illuminating. Across all patients (including underrepresented), physician expertise and relationships were valued most. Underrepresented patients were more comfortable participating in a trial if the PI was a known expert in their condition sixty six percent (66%), a doctor they see regularly fifty six percent (56%), or someone that knew their own doctor well forty nine percent (49%). We also explored the role of demographics (e.g., same race or ethnic background, same gender) and found that these characteristics were more important for Black and Hispanic patients than for white (non-Hispanic) patients, but still less influential than physician expertise and existing relationships.

Strategies for building trust

To help allay fears, build trust and increase participation of underrepresented patients in clinical trials, sponsors need to understand that a multifaceted, “yes, and” approach is required. What do we mean? Consider these three key components:

Leverage existing relationships : One of the best ways to build trust, we believe, is working with physicians who already have a strong reputation and cultural awareness of populations of interest. This may require going into new geographies, partnering with new communities, and working with new investigators that sponsors haven’t engaged before. We also believe there are dual opportunities—both in standing up new sites, as well as encouraging referral pipelines based on existing networks and relationships—to bring clinical trial access to currently underserved and underrepresented patient populations.

Increase frequency of contact : Even where an existing relationship is not present, making a conscious effort to have trial patients see a familiar face during every encounter can help sponsors build relationships and trust between patients and clinical trial professionals. This helps set expectations about study protocols and creates a greater sense of safety. Having a familiar touchpoint helps trial participants feel engaged, connected and supported, which is important across all racial and ethnic groups.

Invest in new communities and channels : Our research also indicated that sites that have been most successful in recruiting underrepresented patient populations utilize a broader array of recruitment approaches and communications channels (including direct print and digital engagement as well as community organizations, advocacy groups and nonprofits). A real-world example comes from Roche/Genentech, which established community partnerships during recruitment for a clinical trial for a COVID-19-related pneumonia treatment. The sponsor’s goal was to increase enrollment of Black, Hispanic, and Native American patients, who were disproportionately affected by COVID-19. One partnership with an Indian health clinic on a reservation led to the highest participation rate across the trial. Approximately 85% of the 389 patients enrolled in the trial were from minority racial and ethnic groups. The main driver was Roche’s commitment to investing in a community beyond only the scope and timeline of the trial.

Three strategies for an intentional approach

Investigators and other site staff recognize the challenges the persist in clinical trial recruitment and are open to sponsors and other partners supporting enrollment efforts. Our VOSP research revealed three areas in which sponsors can make a difference by taking an intentional approach:

• Educating all clinical trial stakeholders on high patient willingness to participate, encouraging PIs and CRCs to broadly offer study opportunities to all their eligible patients. Ensure pre-screening efforts and assumptions are not preventing eligible and potentially interested patients from being offered trial opportunities.
• Training investigators and site staff on how to better communicate trial opportunities in terms of patient benefit. Help patients be aware of the expert care and attention they can expect as part of the clinical trial experience and support sites so they can deliver this.
• Investing in building trust among historically underrepresented populations, beginning from a foundation of existing physician relationships and growing through long-term partnerships with community organizations. Leverage multiple channels to promote trial opportunities, recognizing that underrepresented patients need to hear from their families, friends and community leaders in addition to their own doctor.

We recognize that no single tactic alone will solve the challenge of clinical trial recruitment! The important thing is to begin, step by step, with empathy and in partnership with investigators, site staff and patients themselves. Taken together, the strategies we’ve outlined should contribute to more diverse clinical trials and improved outcomes for all populations.

Sharon Karlsberg , Principal, Cathy Zeanah , Manager; both with ZS Associates

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March 29, 2024 , Filed Under: Uncategorized

Innovative Recruitment Techniques in Healthcare

The healthcare industry is constantly evolving, with new challenges and opportunities emerging at an unprecedented pace. One of the perennial challenges is recruiting talented professionals who can keep up with the demands of the sector. As healthcare organizations strive to improve patient care and embrace technological advancements, innovative recruitment techniques have become more important than ever. This article delves into several cutting-edge strategies that are reshaping how healthcare institutions attract the best talent.

Emphasis on Work-Life Balance

In today’s fast-paced world, the promise of work-life balance has become a critical recruitment tool. Many healthcare organizations now highlight flexible working hours , telemedicine opportunities, and mental health support as part of their value proposition to prospective employees. This emphasis not only attracts candidates looking for a more manageable work environment but also aligns with the increasing need for holistic wellness in the workplace.

The Power of Social Media

Far beyond its use as a tool for social interaction, social media has become a dynamic platform for professional recruitment. Healthcare organizations are leveraging these networks to showcase their culture, highlight success stories, and engage directly with potential candidates. From LinkedIn to Twitter, and even Instagram, these platforms offer a less formal yet highly effective way to attract and interact with healthcare professionals.

One aspect of keeping pace with technological advancements and sector-specific requirements is exploring specialized recruitment services, such as those offered by medical sales recruiting . These services focus on matching the unique needs of healthcare organizations with skilled professionals who have a comprehensive understanding of the medical sales landscape. This targeted approach can be especially beneficial for institutions looking to enhance their recruitment strategies.

Utilizing Gamification in Recruitment

The gamification of recruitment processes is gaining traction in the healthcare sector. This innovative approach involves using game design elements in non-game contexts to attract and engage candidates. Through simulations, virtual reality (VR), and other interactive techniques, candidates can experience a day in the life at a healthcare facility, complete with real-world challenges. This immersive experience allows candidates to gain a deeper understanding of the role and the organization’s culture.

Building Talent Communities

Healthcare organizations are not just looking for candidates; they are looking to build communities of talent. By establishing online platforms where healthcare professionals can connect, share knowledge, and discuss industry trends, organizations create a sense of belonging and engagement. These communities can be a rich source of talent for future recruitment, fostering long-term relationships between professionals and the organization.

Investing in Employer Branding

In a competitive sector like healthcare, a strong employer brand is essential to attract top talent. Healthcare organizations are investing in employer branding that communicates a compelling vision, mission, and set of values. This branding effort not only helps attract candidates who share those values but also differentiates the organization in a crowded marketplace.

Collaborative Hiring Processes

The healthcare sector is increasingly adopting collaborative hiring practices. This technique involves multiple stakeholders, including potential coworkers and department heads, in the recruitment process. The aim is to ensure that the candidate fits not only the role but also the team and organizational culture. Collaborative hiring can lead to more informed decision-making and higher retention rates.

Adapting to Technological Advances

As technology continues to advance, healthcare organizations are adapting their recruitment strategies to align with new tech trends. This includes the use of artificial intelligence for screening applications and automating repetitive tasks in the recruitment process, saving valuable time and resources. By staying ahead of technological trends, healthcare institutions can streamline their recruitment processes and attract tech-savvy professionals.

Focus on Diversity and Inclusion

Diversity and inclusion are becoming increasingly important in healthcare recruitment. Institutions are striving to create diverse workplaces that reflect the communities they serve. This effort not only improves patient outcomes but also enriches the workplace culture, attracting a wider range of candidates. Emphasizing diversity and inclusion in recruitment strategies ensures that all candidates feel valued and have equal opportunities.

Enhancing Candidate Experience

Improving the overall candidate experience is crucial in today’s competitive job market. Healthcare organizations are focusing on making their application processes more user-friendly, providing regular updates, and giving constructive feedback. This positive interaction can build reputational equity, making it more likely for candidates to choose the organization when deciding on their next career move. Ensuring a smooth and respectful recruitment process reflects well on the organization and can significantly influence a candidate’s decision to join the team.

As the healthcare industry continues to face staffing challenges, organizations are turning to innovative recruitment techniques to find and retain the best professionals. From leveraging social media and building talent communities to emphasizing work-life balance and employing gamification in recruitment processes, these strategies are making a significant impact. Healthcare recruitment is no longer just about filling vacancies; it’s about building a vibrant, engaged workforce capable of meeting the demands of tomorrow’s healthcare landscape.

The real voyage of discovery consists not in seeking new landscapes, but in having new eyes —  Marcel Proust

Clinical Research Coordinator II

• Madison, Wisconsin
• SCHOOL OF MEDICINE AND PUBLIC HEALTH/DEPT OF DERMATOLOGY
• Partially Remote
• Staff-Full Time
• Opening at: Apr 1 2024 at 13:35 CDT
• Closing at: Apr 15 2024 at 23:55 CDT

Job Summary:

The Department of Dermatology seeks an experienced Clinical Research Coordinator II to join our team of world-renowned researchers and investigators committed to basic, clinical, and translational research designed to address dermatologic diseases and other skin-related research questions. This position will play a pivotal role in contributing to the conduct of state-of-the-art skin disease research to advance scientific knowledge and thus provide better care to patients. Responsibilities Include: 1. Protocol Development and Management: Collaborate on research protocols and ensure compliance. 2. Regulatory Compliance and Ethics Oversight: Ensure adherence to regulations and ethical standards. 3. Participant Recruitment and Consent Management: Strategize recruitment strategies and manage informed consent processes. 4. Data Oversight and Quality Control: Oversee data collection, verification, and maintain quality control. 5. Site Coordination and Monitoring: Coordinate site activities, conduct monitoring visits, and ensure safety. 6. Communication and Reporting: Serve as the main contact, communicate study progress, and generate reports.

Responsibilities:

• 25% Schedules logistics, determines workflows, and secures resources for clinical research trials
• 15% Recruits, screens, selects, determines eligibility and enrolls trial participants, collects more complex information, performs medical assessments, and answers varied questions under supervision of a medically licensed professional. Performs medical assessments after completion of required training/certification, such as collecting vital signs, obtaining weight, and performing phlebotomy
• 5% Manages research workflow components, collects, prepares, processes, and submits participant data and samples to appropriate entities, adhering to research protocols
• 5% Identifies work unit resources needs and manages supply and equipment inventory levels
• 5% Serves as a main point of contact for clinical research participants, providing information regarding research procedures, expectations, and informational inquiries. Ensures participants follow the research protocol and alerts Principal Investigator of issues
• 5% Performs quality checks
• 15% Identifies resource needs and develops clinical research documents, such as job aids, tools, processes, procedures, and training. Contributes to the development of protocols
• 5% May assist with training of staff
• 10% Performs administrative duties related to managing clinical research protocols in the Department of Dermatology
• 10% Performs clinical research finances

Institutional Statement on Diversity:

Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals. The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world. For more information on diversity and inclusion on campus, please visit: Diversity and Inclusion

Preferred Bachelor's Degree

Qualifications:

Experience: - Experience with clinical research regulations, including OHRP, CTMS, GCP required. - 1-2 years working in a research or clinical trials environment required. - Experience in approaching patients to discuss clinical trials and their potential participation, and obtaining informed consent required. - Demonstrated experience in scheduling, coordinating, and conducting visits and study meetings preferred. Knowledge and Skills: -Reading and understanding of research principles and methodology and be able to apply that knowledge to a clinical trials environment. -Strong oral and written communication skills -Strong attention to detail. -Ability to interact well with patients and researchers independently. -Ability to use good initiative and judgement. -Ability to structure time to meet multiple deadlines.

License/Certification:

Preferred Drivers License - Valid and Meets UW Risk Management Standards

Full Time: 100% This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location.

Appointment Type, Duration:

Ongoing/Renewable

Minimum $45,000 ANNUAL (12 months) Depending on Qualifications This position is eligible for a hiring bonus in the amount of $3,000. Employees in this position can expect to receive benefits such as generous vacation, holidays, and paid time off; competitive insurances and savings accounts; retirement benefits. Benefits information can be found at ( https://hr.wisc.edu/benefits/ ). SMPH Academic Staff Benefits flyer: ( https://uwmadison.box.com/s/r50myohfvfd15bqltljn0g4laubuz7t0 ).

Additional Information:

This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years. The successful applicant will be responsible for ensuring eligibility for employment in the United States on or before the effective date of the appointment. University sponsorship is not available for this position.

How to Apply:

To apply for this position, please click on the "Apply Now" button. You will be asked to upload a current resume/CV and a cover letter briefly describing your qualifications and experience, and a document listing contact information for three (3) references, including your current/most recent supervisor. References will not be contacted without prior notice.

Caitlin Staley [email protected] 608-265-1325 Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information.

Official Title:

Clin Res Coord II(RE016)

Department(s):

A53-MEDICAL SCHOOL/DERMATOLOGY/DERMATOLOG

Employment Class:

Academic Staff-Renewable

Job Number:

The university of wisconsin-madison is an equal opportunity and affirmative action employer..

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• J Clin Transl Sci
• v.7(1); 2023
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Community engagement strategies to promote recruitment and participation in clinical research among rural communities: A narrative review

Tabetha a. brockman.

1 Center for Clinical and Translational Science, Mayo Clinic, Rochester, MN, USA

2 Department of Psychology and Psychiatry, Mayo Clinic, Rochester, MN, USA

Olivia Shaw

3 Virginia Polytechnic Institute and State University, Blacksburg, VA, USA

Liana Wiepert

4 Tufts University, Medford, MA, USA

Quang Anh Nguyen

5 Luther College, Decorah, IA, USA

Sydney S. Kelpin

6 Columbia University, New York, NY, USA

Monica Albertie

7 Center for Health Equity and Community Engagement Research, Mayo Clinic, Jacksonville, FL, USA

Shantel Williams

Adeline abbenyi, noreen stephenson, diana almader-douglas.

8 Education Administration, Mayo Clinic, Rochester, MN, USA

Christi A. Patten

Residents of rural areas are underrepresented in research. The aim of this narrative review was to explore studies describing the effectiveness of community engagement strategies with rural communities to promote participant recruitment and participation in clinical research. Following PRISMA guidelines, this narrative review was conducted in June 2020. Our search strategy was built around keywords that included community-engaged research, rural community, and recruitment strategies into clinical research. Content-related descriptive statistics were summarized. The selected articles were distributed into categories of levels of community engagement: inform, consult, involve, collaborate, or co-lead. The search resulted in 2,473 identified studies of which forty-eight met inclusion criteria. Of these, 47.1% were randomized controlled trials. The most common levels of engagement were consultation (n = 24 studies) and collaboration (n = 15), while very few focused on informing (n = 2) and co-leadership (n = 2). Strategies, limitations, and findings are discussed for each level of community engagement. This narrative addressed a gap in knowledge regarding participant recruitment in rural communities in relation to assistance from community members. Community engagement contributed to the success of the research, especially in recruitment, participation, and building trust and partnership.

Introduction

Despite well-documented health disparities among rural residents, they remain underrepresented in clinical research [ 1 ]. Although approximately 14% of US residents live in rural areas, only 3% of the National Cancer Institute’s clinical research focused on rural populations between 2011 and 2016 [ 2 , 3 ]. Some factors contributing to this are that rural populations in America face several barriers to healthcare compared to urban and suburban populations, and clinical research studies are often offered as part of medical encounters [ 4 ]. Barriers to accessing healthcare in rural communities include geographical distances to medical facilities requiring extensive travel and lodging costs, lack of public transportation, stigma, and distrust of the healthcare system [ 5 , 6 ]. Representation of rural populations in clinical research is necessary to understand and deploy effective health care strategies that can benefit all rural individuals, increasing the generalizability and equity of research findings.

Recently, developing infrastructure and capabilities for clinical research to address health disparities among rural populations has been viewed as a national priority [ 7 , 8 ]. In response, collaborative efforts involving community-academic partnerships on community engagement, late-stage translation, and digital infrastructure have begun to address the inadequate digital infrastructure and barriers to health care access among rural communities [ 9 , 10 ]. A body of evidence showed that recruitment and participation of rural populations can be facilitated through community engagement in research [ 11 , 12 ]. Collaboration with community members has numerous merits including addressing prevalent health issues, strengthening researchers’ understanding of community priorities, and supporting culturally appropriate communication [ 13 ]. However, evidence for a comprehensive understanding of specific strategies for promoting participation in clinical research among residents of rural communities is unclear.

The goal of this narrative review is to evaluate the extant literature about the use of community engagement strategies to promote recruitment, enrollment, and participation in clinical research with rural communities. This review will highlight effective strategies in promoting participation and identify ineffective ones. This knowledge will progress the current understanding of the issue and outline specific strategies that can be applied in clinical research based in rural settings.

To achieve the proposed objective, a narrative review was used to address the knowledge gap on ways to engage and promote clinical research in rural communities. This narrative review followed the PRISMA-ScR guidelines to plan, conduct, and report the results [ 14 ].

Data Sources and Search Strategies

Online searches were conducted using a variety of different strategies with assistance from an experienced medical librarian. We searched PubMed, Embase, CINAHL, Scopus, Web of Science, and Cochrane Database of Systematic Reviews to identify English-language manuscripts about clinical research among rural communities. Searches of ClinicalTrials.gov were conducted to capture unpublished or ongoing research. A variety of keywords, some truncated, and subject headings were combined using Boolean operators to retrieve results in the databases. The searches included terms such as “community engaged research,” “CEnR,” “rural populations,” “recruitment,” “intervention,” “research subjects,” and “patient selection.” Results were restricted to human subjects and clinical research publication type.

Study Eligibility and Outcome Measures

In this review, studies were eligible for inclusion if they included community engagement approaches, recruitment, and enrollment of rural participants to clinical research in the United States. Clinical research was defined as “ A component of medical and health research intended to produce knowledge valuable for understanding human disease, preventing and treating illness, and promoting health ” [ 15 ]. Key components included a sponsor, study question, study population, inclusion/exclusion criteria, observation and/or intervention, and outcomes. Types of research studies included were bi-directional integrative (translational) research, community-based clinical research, therapeutic interventions, prevention and health promotion, behavioral research, and health services research. Exclusion criteria were non-English articles, studies conducted outside the United States, systematic reviews, non-original research, and did not include rural populations. In some strategies, the text words and publication types “systematic reviews” and “meta-analyses” were also excluded. No publication period restrictions were applied to the database searches (Table  1 ).

Summary of inclusion and exclusion criteria for the narrative review

Screening and Data Extraction

All records were screened among two-three reviewers by title and abstract, full text, and data extraction. Covidence was used for all study screening and data extraction activities. For data extraction and synthesis, three reviewers were assigned to each article, with decisions based on agreement among two-three of the reviewers. The following items were extracted from these studies: study design, study focus (recruitment, retention, or both), study population(s), study setting(s), number of rural research participants recruited, study description/aim, community engagement intervention for rural recruitment, level of community engagement, and major findings from the study.

The International Association for Public Participation’s Spectrum of Public Participation [ 16 ] broadly categorizes community engagement; thus, the levels of community engagement were adapted and defined as follows: (1) inform – communities are provided with information about research opportunities, (2) consult – feedback is solicited from communities for research procedures, (3) involve – communities informed and participate in research procedures, (4) collaborate – partnerships are formed with communities to work together on all procedures, and (5) co-lead – robust partnership with communities who hold decision-making power over all research procedures. If applicable, the number of urban participants was also extracted from the study. All data extraction, synthesis, and consensus were captured in Covidence for summarizing and comparisons.

Synthesis of Results

Following the data extraction process, the information gathered was coded for the following: strategies that worked to recruit participants, strategies that did not work to recruit participants, and recruitment findings/outcomes. Three reviewers were involved in this process, and the data were then combined for one final consensus.

Search Results

Database searches retrieved a total of 3382 papers, which yielded 2473 unique papers after de-duplication. In screening the titles and abstract, 2068 articles were excluded because of irrelevant populations, study type, setting, or missing abstract. After further screening, investigators then reviewed 405 papers of which forty-eight articles were identified to have fulfilled the inclusion criteria (see Fig.  1 ).

PRISMA flow diagram.

Characteristics of Included Studies

The included studies were published between 1990 and 2021. Of the forty-eight articles, almost half (41.7%) were randomized controlled trials, and a third were quasi-experimental studies (27.1%). The remaining articles included mixed methods (8.3%), cohort designs (8.3%), cross-sectionals (8.3%), non-randomized clinical research (2.1%), case studies (2.1%), and stratified random sample studies (2.1%). The majority (91.7%) focused on rural communities, and the remaining (8.3%) included both rural and urban communities. The bulk of the included articles (70.8%) either focused on or included underrepresented groups including African American, Hispanic, American Indian or Alaska Native (AIAN) or Asian people, or the transgender community. The health-related themes of forty-eight articles were diverse; however, these were clustered into five categories: nutrient-related and nutrient processing problems (39.6%), cancer (29.2%), behavioral and physical health (27.1%), cardiovascular issues (16.7%), patient engagement (6.3%), and mental health (2.1%). Although there are some articles that only emphasized one health disparity, some had multiple. Over two-thirds (68.8%) were conducted in community settings, while 18.8% were in clinical settings and 18.8% at home or by phone. Two studies were conducted in multiple settings (Table  2 ).

Characteristics of selected articles

Recruitment Strategies

All the studies were examined in four categories: recruitment strategies, recruitment strengths, recruitment limitations, and findings (Table  3 ). Of the forty-eight articles included, thirty-one had a study focus on recruitment. Most of these relied on community engagement for successful recruitment of research participants. Involvement of community personnel (n = 46) [ 17 – 62 ], feedback (n = 22) [ 18 , 20 , 23 , 25 , 26 , 31 , 32 , 34 , 38 , 42 – 45 , 49 , 51 – 53 , 55 – 57 , 61 , 62 ], and customization of recruitment materials and processes in accordance with the characteristics of the community (n = 17) [ 19 , 22 , 25 – 27 , 32 , 34 , 45 , 47 – 50 , 52 , 56 , 58 , 61 , 63 ] were mentioned most frequently. Some other recruitment strategies included providing remuneration (either for participants or for community personnel) (n = 14) [ 19 , 23 , 31 , 33 , 35 , 37 , 42 , 44 , 48 , 49 , 51 , 54 , 58 , 61 ] and utilizing local spaces and events (n = 15) [ 19 , 21 , 22 , 28 – 30 , 38 , 39 , 42 , 46 , 56 , 58 – 60 , 63 ]. Although the majority of articles did not discuss limitations of the recruitment strategies, a few mentioned some challenges, including issues regarding community personnel recruitment [ 55 , 61 ], community personnel turnover [ 20 , 61 ], study interval [ 54 ], absence of educational programs [ 54 ], and ineffective recruitment via faith-based organizations [ 55 ]. Numerous outcomes of the recruitment strategies were discussed, most of which were positive. Among all the findings, production of tailored materials and procedures (n = 17) [ 19 , 25 – 28 , 31 , 34 , 45 , 48 , 51 , 52 , 56 , 58 – 60 , 62 , 64 ], improved participant recruitment (n = 19) [ 19 , 20 , 22 , 25 – 27 , 34 , 35 , 37 , 41 , 43 , 46 , 52 , 56 , 58 , 59 , 61 – 63 ], building partnership (n = 9) [ 20 , 23 , 27 , 40 , 42 , 49 , 55 , 56 , 61 ], and increased trust (n = 8) [ 23 , 27 , 35 , 40 , 50 , 58 , 61 , 63 ] were the most commonly observed outcomes. Additionally, there were other noteworthy outcomes: seven studies discussed improved participant retention [ 22 , 25 , 27 , 39 , 58 , 62 , 63 ], five studies successfully addressed community needs [ 52 , 57 , 61 , 62 , 64 ], and five studies effectively encompassed hard-to-reach populations [ 28 , 29 , 41 , 56 , 58 ].

Levels of community engagement for recruitment

Levels of Rural Community Engagement

Among the 48 articles, only 2 involved the community at the “inform” level [ 41 , 54 ]. Both studies utilized visual mediums as methods of recruitment, specifically TV ads in Kupfer’s article and community presentations in Gold’s article. Although Kupfer’s study was successful in engaging African American population [ 41 ], Gold identified three shortcomings in that study including initial failure to involve community members to produce tailored educational materials, an absence of ongoing educational programs, and the short interval of the study [ 41 ].

There were five studies identified as engaging the community at the “consult” level [ 34 , 42 , 46 , 53 , 65 ]. The community members provided different types of support to the research teams. Although in one study, the recruited community leaders helped validate the legitimacy of the research to elder participants of the community, another demonstrated the effectiveness of a focus group which helped inform the various aspects of the intervention including acceptability, marketing, content, and environment [ 34 , 46 ]. The articles reported some major advantages of engaging the community members in consultation. Cruz maintained that involvement of community members who advocated for the project served to build a foundation of trust and to ensure equity in the partnership, while McMahon noted that the community partners provided advice of great value regarding maximizing participant recruitment and retention [ 42 , 53 ].

Involvement was identified as the level of engagement in half of the studies (n = 24) [ 17 , 19 , 21 , 22 , 26 , 28 – 30 , 32 , 33 , 36 , 38 , 39 , 45 , 47 , 48 , 55 – 61 , 63 ]. In most of these studies, the research teams developed partnerships with local organizations or recruited community personnel and liaisons. These community partners provided insights into the study processes and materials, as well as managing and executing the recruitment process. By employing local members as study staff in the recruitment, populations that would be otherwise unable to reach were engaged in the study due to the increased trust among community members, as observed in Leach’s success in involving rural Appalachian women [ 58 ]. Furthermore, the community partners also helped in tailoring materials and processes to address the communities’ specific needs and characteristics, further improving the effectiveness of recruitment. However, it must be noted that there are some limitations to involving communities to participate in the research procedures. Leach outlined that the effectiveness of community partners recruiting participants was greatly reduced due to the topic of cancer, which was too frightening, especially for those who had experienced loss of loved ones due to cancer. Moreover, some recruitment mediums in the community including emails, paid newspaper advertisements, community flyers, and postcards have also been illustrated to lack efficacy in recruiting participants [ 59 ].

Collaborate

Collaboration was the level of community engagement in fifteen articles [ 18 , 20 , 23 , 27 , 31 , 35 , 37 , 40 , 43 , 44 , 49 – 52 , 64 ]. In these studies, community members were involved in numerous phases of the research, including problem assessment, recruitment, data collection, and evaluation. The results of collaboration with community members were quite positive. Some of the benefits of collaboration with community personnel include increased trust, improved participant recruitment, partnership between the research group and the locals, production of specialized materials and processes, and addressing the needs of the community. Furthermore, Hopper and colleagues [ 18 ] showed that early dedication of time and resources to engage community participation generated well-informed intervention and procedures, both of which were more easily accepted and effectively disseminated within the community.

Co-leading is the driving principle regarding community personnel in only two studies [ 25 , 62 ]. In Angell’s study, the skills and knowledge of community personnel were integrated into the model which produced numerous interpersonal contacts between recruiters and potential participants and received great advocacy from the community [ 25 ]. In Schroepfer’s research, the community leaders who had expressed interest in the study met with university partners to assess the study’s accuracy, cultural appropriateness, and other related areas including questions involving insurance [ 62 ]. The findings from these two articles maintained that the presence of community members in every step greatly reduced barriers to participation and ensured that the data collected was distinct and bore benefits to the community, adhering to the standards of equitable and ethical research.

This review unveiled a body of literature regarding the use of community engagement strategies in research conducted in rural populations. The engagement of community members in research was shown to be of great benefit to study recruitment, participant participation, building partnership and trust with the community, and creation of materials and processes tailored to the community’s specific characteristics. Furthermore, engagement of community personnel in the research team ensured that the research was relevant to the community, addressed its specific needs, and benefited the community with its results. This idea of involving community members in the research team has recently been highlighted by existing health programs. A survey conducted in 2011 of the Clinical and Translation Science Awards programs demonstrated that 89% of the projects engaged Community Advisory Boards [ 66 ]. Thus, it can be maintained that the role of community engagement in research is crucial and is becoming increasingly better acknowledged within the scientific community.

The majority of studies utilized community partners to inform the research regarding recruitment, study materials, and dissemination of the intervention. Different levels of engagement imply different impacts by the community members on the research. Involvement of community personnel is most effective in the recruitment stage in which either the members provide advice on appropriate strategies, directly recruit participants, or serve as a connection between research members and residents of the community [ 45 , 47 ]. The presence of community members in this stage has been shown to greatly increase participant recruitment, as well as retention in some studies [ 63 ]. Moreover, involvement of community members in the research team can also foster increased trust between the researchers and the community participants [ 58 ], which is critical to facilitating effective intervention and access to hard-to-reach populations [ 67 ].

Although it was not included in the original inclusion criteria, partnership with local organizations, which is essential in establishing relationships in rural communities, was mentioned in 29 studies [ 17 , 18 , 22 , 24 , 26 – 29 , 32 , 35 – 43 , 47 , 48 , 50 – 52 , 55 , 56 , 59 – 61 , 64 ]. The majority of partnerships were formed with faith-based organizations (70%) and/or local health-related facilities (55%). Additionally, some other organizations involved as partners in the research were local businesses, schools or educational institutions, and general local community organizations. The importance of engaging with rural community-based organizations as a method of promoting research participation has been noted in various literature [ 68 – 70 ], as well as the CDC’s Principles of Community Engagement [ 71 ]. Culturally appropriate designs and trust in the research are important factors in engaging with the community [ 72 ], which can be facilitated through partnering with community-based organizations and receiving feedback from them. Through building solid relationships with existing local organizations, researchers can familiarize the research to a body of residents and help spread information about the project within the community. Because the majority of the selected papers did not explore the theme of participation engagement exclusively, more research exploring the effects of partnership with community-based organizations is warranted.

Successful recruitment observed in numerous studies was mostly attributed to the engagement of community members who advocated for the study. Most of the studies employed involvement and collaboration as the strategies to engage the community. Compared to information and consultation, collaboration, and involvement transfer some of the decision-making ability to the community members, as they can directly make decisions that impact the studies, evoking a sense of ownership and responsibility toward the research. In a corporate setting, involving employees in the decision-making process can induce a sense of ownership, produce an alignment of interest, and improve overall productivity and quality [ 73 ]. In the setting of clinical research, this can translate into improvement of the quality and effectiveness as observed in the selected articles. Additionally, with more power, community members can positively influence the procedures, strategies, and materials to ensure they best address and benefit the members of the community.

Of the forty-eight studies, only two employed co-leadership as the method of community engagement; however, the findings were very promising. In Angell’s article, efforts made by the community and their input were depicted as indispensable components to the research’s success. Moreover, Schroepfer’s study demonstrated that co-leadership empowered the community, enhanced the capacity of conducting research, and allowed for interpretation of data within the framework of local knowledge, available resources, specific values and beliefs [ 25 , 62 ]. These positive results certainly highlight the need for future research employing co-leadership as the engagement principle. Notably, both community personnel recruitment and turnover were mentioned as some of the potential challenges of this approach to consider in future research.

Only seven of the studies focused on implementing community engagement strategies among American Indian and Alaska Natives (AIAN) persons [ 18 , 42 , 44 , 46 , 52 , 61 , 62 ]. This is important to consider as AIAN communities remain disproportionately rural compared to other groups, with 29% identified as living in rural areas in 2010 compared to 15% of the total US population [ 74 ]. Comprising a large part of rural communities, AIAN people must be included in clinical research in order to learn effective community engagement strategies within this population. Moreover, community engagement techniques may be particularly beneficial when working with AIAN people due to research historically often not addressing community priorities and with little regard for cultural practices [ 75 ]. Furthermore, research has often been done without seeking consent from Indigenous communities or not communicating clearly when obtaining consent [ 76 ]. Recent initiatives have called for the need for more culturally sensitive and collaborative approaches in research with indigenous populations [ 77 , 78 ]. Community engagement strategies could provide a necessary framework for such efforts; however, more research is needed to better understand best practices within this population.

There are several limitations to the present review. While each level of engagement demonstrated unique benefits to the research, none of the included studies directly compared the different levels of engagement. In future research, it will be beneficial to understand the context in which each level would yield the highest contribution to the successes of the study. Furthermore, knowledge of different engagement principles will also determine balancing community involvement in decision-making and maintaining scientific vigor. Our narrative review is limited to research conducted in the United States and studies published in the English language, limiting generalizability to other countries and languages. Future narrative reviews that include international studies are needed to learn from the work of our neighbors and international partners such as Australia and Canada, who are working on similar issues. Moreover, this review highlights that compared to the whole, CEnR with rural populations occupy only a small portion of the existing body of research. Hence, more CEnR is needed in rural settings that are often underrepresented in the scientific world [ 4 ]. Additionally, specific definitions and characteristics of rurality were not captured in the present review (e.g., town size). Rurality is a multidimensional concept, and there is great variation across rural communities that need to be considered when implementing community engagement strategies.

This review highlighted the sizeable contributions community members and community leaders can have to the success of research. Most of the studies used collaboration and involvement as the principle driving community engagement. It can be easily observed that including community members on the research staff can enhance the quality of the research, appropriateness of the materials, and effectiveness of intervention delivery. Although it contains many benefits, community engagement is not the omnipotent answer to tackle every barrier, such as transportation, geological isolation, or insufficient services and infrastructure, all of which contribute to the exclusion of rural populations in clinical research. However, it is a necessary component to include in any solution to resolve these issues. Community engagement strategies produce more equity in clinical research, as the participants are part of the team and can ensure that the research is appropriate and beneficial to community. Additional research on community-engaged strategies to enhance clinical research participation among rural populations is warranted [ 4 ].

Acknowledgements

This publication was supported by Grant Number UL1 TR002377 from the National Center for Advancing Translational Sciences (NCATS). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.

Disclosures

The authors have no conflict of interest to disclose.