Strategies for Patient Recruitment: Promoting Equitable Inclusion of African Americans in Clinical Trials
New patient recruitment strategies are necessary to engage the African American community in clinical trials, as socioeconomic barriers, investigator bias, inadequate healthcare resources and literacy,1 and experiences resulting in clinical mistrust2,3,4,5 are all challenges to recruiting this population. African Americans make up 13.4% of the U.S. population but only 5% of cancer trial participation.6 This is especially unequitable, as African Americans have the highest death rate and shortest survival rate in the U.S. for most cancer diagnoses.7 Similarly, African Americans are dying of COVID-19 at a 1.4 times greater rate than White Americans,8 but are not equitably included in COVID-19 clinical trials. The SARS-CoV-2 pandemic has illustrated the importance for implementation of patient recruitment and engagement strategies to overcome challenges in recruiting this population in clinical trials.
The Importance for New Patient Recruitment Strategies
Although among the most vulnerable populations to contract SARS-CoV-2 and experience severe COVID-19 illness, African Americans remain underrepresented in COVID-19 clinical trials. While the COVID-19 trials enroll diverse populations, their participant ratio is inequitable because it is not reflective of the racial distribution within the affected populations. For example, in the placebo-controlled Adaptive COVID-19 Treatment Trial (ACTT-1) of 1063 patients,9 the race distribution was as follows: White – 53.3%, Black – 21.3%, Asian – 12.7%, Hispanic or Latinx – 23.5% and participants designated as other or not reported – 12.7%.10 Even though most participants were White, greater mortality rates caused by COVID-19 infection are reported in African Americans, American Indian or Alaskan Natives, Hispanic or Latinx, and Native Hawaiian or Other Pacific Islanders.8 Equitable inclusion in clinical trials is important because racial groups have genetic traits and predispositions to comorbidities that may be inadequately assessed in relation to the study drug when trials are not equitably inclusive. Specific to African Americans and COVID-19, the equitable inclusivity of this population would better observe COVID-19 associated rash on darker skin,11,12 and/or the effects of the study drug in relation to sickle cell anemia or trait, cardiovascular disease, high blood pressure, diabetes, asthma, and sarcoidosis, as these traits and comorbidities are common in this population.
Unlike recent COVID-19 clinical trials, in a study with limited patient diversity, ideally the Food and Drug Administration (FDA) would require subgroup analyses13 or post approval studies14 to ensure efficacy and safety outcomes apply specific to race, after the drug is approved. Additional analyses may be reduced by implementing vigorous patient recruitment methods that promote equitable inclusion which will improve study drug generalizability. Equitable inclusion of most affected populations in clinical studies may minimize concerns for efficacy specific to race once the study drug is provided to the greater population. When the study is federally funded and the pharmaceutical company is the sponsor, racially targeted patient recruitment strategies should be applied to comply with the Public Health Service Act sec. 492B, 42 U.S.C. sec. 289a-2,15 National Institute of Health (NIH) policy NOT-OD-18-01416 and the Revitalization Act 1993.17
Strategies to Overcome Challenges of Recruiting African Americans in Clinical Trials
To address strategies to improve African American population recruitment and retention in clinical trials, companies should evaluate clinical trial feasibility to ensure recruitment and retention measures yield and maintain an equitably diverse participant sample that supports generalizability of study outcomes.
Recruitment Initiatives: In TRI’s experience, adopting a strategic recruitment system or contracting a skilled recruiter to target diverse populations will improve participant diversity. The strategic recruitment system should include a step-by-step manual with guidance, tips, sample messages, newsletters, media templates, and an image library for recruitment materials that are specific to the target racial or ethnic demographic. Recruiters contracted to improve enrollment diversity should be aware of social media trends and vernacular within the African American community to create meaningful recruitment materials. Additionally, the recruiter should have innovative ideas to overcome enrollment challenges manifested by the historical clinical trial distrust among this population. Contracting a recruiter that is an expert in increasing African American participation will help ensure the recruitment initiatives yield desired outcomes.
Clinical Site Selection: It is important to ensure clinical sites are geographically located in relation to the target demographic. In a multisite trial, to improve trial visibility by African Americans, a sufficient number of clinical sites should be positioned in communities that have a relatively large African American population. Specifically, HBCUs are usually located in African American communities. Including clinical sites at HBCU medical schools, such as Morehouse College of Medicine, Howard University School of Medicine, Meharry Medical College or Charles R. Drew University of Medicine and Science will increase visibility of clinical trial enrollment. Additionally, trial visibility may be increased by partnering with community clinics in African American communities. When selecting sites that are not HBCUs or community clinics, companies can track geographical distribution of the patients most affected by the disease under observation using zip codes. In doing so, sites may be selected that are located near or within zip codes with the most affected or target population.
How to Target the African American Population for Patient Recruitment: Recruitment materials should include graphics that are reflective of African Americans of affected ages, gender, economic, sociocultural, and ethnic demographics with other races, as applicable. In doing so, African Americans can identify a connection with the study, which will lead to volunteering or agreeing to participate. Representation of other races in graphics may also reduce skepticism around participating. Focus groups should be convened to create sample messages to promote trial enrollment that are specifically targeted at this community. Sample messages should be shared with or targeted to African American religious leaders, community organizations, community clinics, Historically Black Colleges and Universities (HBCUs), professional associations, and the National Pan-Hellenic Council Sororities and Fraternities. Overall trial visibility will be increased, as professional associations and the National Pan-Hellenic Council Sororities and Fraternities have national networks. HBCUs are geographically located in African American communities, as well as have robust alumni organizations that may assist in trial visibility and information dissemination. Collaborating with or using these entities as resources for information distribution will target the African American community directly. Also, social media platforms (i.e., Facebook, YouTube, Instagram, Twitter, etc.) can be used to extend trial visibility and directly target the intended demographic. This can be accomplished by creating an advertisement within the media platform and selecting appropriate user settings (i.e., ad objective, target audience, ad format, etc.) to solicit a specific demographic.
How to Reduce Participation Costs for the African American Population: As participants arrange the rigorous requirements of clinical studies into their daily schedules, reducing burdens associated with participation may improve retention. Mitigating travel costs when sites are not geographically relative to African American communities and providing meal vouchers to participants will reduce financial burdens associated with clinical trial participation. In some cases when transportation reimbursement is provided, it is often not immediate. This forces participants to pay out of pocket in the moment to meet study demands, which can be an obstacle to participate in a trial. Partnering with travel services (i.e., Uber, Lyft, etc.) to facilitate transportation will eliminate this concern, as the study can pay for travel services directly. An additional avenue to eliminate travel costs and improve retention is incorporating home nurse visits to conduct simple assessments (i.e., vital signs, drug compliance, etc.) for participants without stable transportation, reliable childcare, or other personal requirements that might prevent the ability to attend an in-person visit.
Retention Initiatives: Creating avenues for communicating with the study site electronically will help minimize participant perceived barriers. Although some in-person visits are necessary to assess safety and efficacy of the study drug, the number of in-person visits may be reduced by implementing electronic communication mechanisms. This will allow for real-time reporting of non-serious adverse events electronically, which will streamline the reporting process and may promote active participation by reducing loss to follow-up. Implementing a mobile app, text message or email system will allow participants and the study site to interact without constraints of scheduling an in-person appointment or calling the facility. These systems are also useful for communicating appointment reminders and study updates. In instances where patient safety will not be compromised, implementing phone calls in place of in-person visits may improve retention. In addition, creating an online portal for participants to submit safety and/or efficacy data may also support the effectiveness of phone call visits. To accommodate participants of lower socioeconomic status or who are resource-limited, providing a smartphone or tablet will improve their ability to interact with the study team electronically, participate in phone call visits, submit safety and/or efficacy data via online portal, and receive automated reminders and/or updates. Innovative communication avenues for participants to interact with study staff outside of the clinical setting will contribute to dismantling the “guinea pig” perception of clinical trial participation and improve patient agency, as well as alleviate external constraints for participation and increase retention. In studies where electronic communication cannot be implemented due to budget, planning, or staffing constraints, selecting clinical sites relative to the location of the African American population will also contribute to participant retention. This will minimize possible inconveniences associated with transportation, which will improve participant adherence to follow-up appointments and other in-person requirements. Implementing a participant and/or caregivers survey at the end of each trial will inform the study team of participants opinions regarding the demands of the study. The study team can use this information to incorporate retention initiatives specific to participant concerns and/or apply the data to patient recruitment and retention initiatives for a developing study.
About the Author
Destini Garrison is a Science Communications Specialist at TRI. She earned an M.S. in Biomedical Science Policy and Advocacy from Georgetown University and a B.S. in Biology from Virginia Wesleyan University.
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