Community engagement and clinical trial diversity: Navigating barriers and co-designing solutions—A report from the “Health Equity through Diversity” seminar series

Abstract

Introduction In recent years, there has been increasing awareness of the lack of diversity among clinical trial participants. Equitable representation is key when testing novel therapeutic and non-therapeutic interventions to ensure safety and efficacy across populations. Unfortunately, in the United States (US), racial and ethnic minority populations continue to be underrepresented in clinical trials compared to their White counterparts. Methods Two webinars in a four-part series, titled “Health Equity through Diversity,” were held to discuss solutions for advancing health equity through diversifying clinical trials and addressing medical mistrust in communities. Each webinar was 1.5 hours long, beginning with panelist discussions followed by breakout rooms where moderators led discussions related to health equity and scribes recorded each room’s conversations. The diverse groups of panelists included community members, civic representatives, clinician-scientists, and biopharmaceutical representatives. Scribe notes from discussions were collected and thematically analyzed to uncover the central themes. Results The first two webinars were attended by 242 and 205 individuals, respectively. The attendees represented 25 US states, four countries outside the US, and shared various backgrounds including community members, clinician/researchers, government organizations, biotechnology/biopharmaceutical professionals, and others. Barriers to clinical trial participation are broadly grouped into the themes of access, awareness, discrimination and racism, and workforce diversity. Participants noted that innovative, community-engaged, co-designed solutions are essential. Conclusions Despite racial and ethnic minority groups making up nearly half of the US population, underrepresentation in clinical trials remains a critical challenge. The community engaged co-developed solutions detailed in this report to address access, awareness, discrimination and racism, and workforce diversity are critical to advancing clinical trial diversity.

PrEP‐aring stylists: Development of a stylist educational workshop to increase PrEP awareness and knowledge among Black women in the US south

“…More research is needed on whether allowing flexibility in data collection (e.g., participants completing surveys before arrival or after departure) is needed. Additionally, Black women leading the workshop could have contributed to participants' comfort with discussing sensitive information (Fryer et al, 2016;Reopell et al, 2023). Therefore, cultural congruence and similarities in age, gender, and sexual identity may is key to the intervention's success and may also increase trust in research in a community that has been under-engaged.…”

Barriers to diverse clinical trial participation in Duchenne muscular dystrophy: Engaging Hispanic/Latina caregivers and health professionals

“…Trust encourages open dialogue, allowing families and patients to express concerns or ask questions about the trial. Diversity and representation in the health care and clinical trial teams enables better cultural competence and can increase trust [ 34 ].…”

More than Just a Number: Perspectives from Black Male Participants on Community-Based Interventions and Clinical Trials to Address Cardiovascular Health Disparities

“…Despite the extensive recognition of barriers to recruiting and retaining Black Americans, minimal progress has been made in terms of increasing the representation of this group in clinical trials. To reach the goal of the National Institutes of Health Minority Health and Health Disparities' strategic plan to increase the overall proportion of participants from diverse populations included in NIH-funded clinical research to 40% by 2030 [65], researchers must prioritize recruiting and retaining underrepresented groups by thoughtfully creating sustainable studies rooted in community-engaged efforts that address well-documented barriers and utilize facilitators that promote participation [13].…”

“…A number of factors influence life expectancy in Black men, including socioeconomic barriers [7], perceived racism [8], social networks [8,9], health knowledge or awareness [8], and masculinity beliefs [10,11]. As clinical trials provide novel and life-changing therapies, increasing participation among Black American men is vital [12][13][14]. Without adequate representation, it becomes difficult to ensure generalizable findings, due to a potential lack of variability in responses in homogenous populations [15].…”

“…Addressing the pronounced underrepresentation of Black adults in NIH-funded cardiovascular trials, coupled with the lack of specific enrollment plans, calls for targeted interventions that thoroughly tackle barriers and facilitators across every phase in a given study. Identified barriers to the participation of Black Americans in clinical trials include medical mistrust, concerns of integrity among researchers, a lack of information, time and resource constraints, opportunity costs, as well as racism and discrimination [13,14,22,23]. Unsurprisingly, many of these barriers can be traced back to the long and sordid history of medical abuse and experimentation on Black Americans [24].…”