Improving Representation in Clinical Trials and Research Building Research Equity for Women and Underrepresented Groups (2022) / Chapter Skim
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While progress has been made on some fronts, particularly with representation of white women in clinical trials and clinical research, progress has largely stalled on participation of racial and ethnic minority population groups. Additionally, older adults, pregnant and lactating individuals, LGBTQIA+ populations, and persons with disabilities remain underrepresented and even excluded from clinical trials and clinical research.1 An equitable clinical research enterprise would include trials and studies that match the demographics of the disease burden under study.
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According to an analysis by GlobalData, low accrual was the cause for stopping 55 percent of all Phase I–IV clinical trials that were terminated, suspended, or discontinued during 2008–2017. Thus, increasing enrollment of underrepresented and excluded populations would help solve the leading cause of clinical trial failure.
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The analysis also revealed that the racial and ethnic diversity of clinical trials is largely stagnant, with little changes in diversity over time. UNDERREPRESENTED AND EXCLUDED POPULATIONS ARE WILLING TO PARTICIPATE IN CLINICAL RESEARCH, IF ASKED Due to well-documented historical and contemporary abuses against certain excluded and underrepresented populations in medical research, members of the research community often assume that a lack of willingness to participate in research is the major driver of poor representation of some populations in research.
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BARRIERS TO REPRESENTATION OF UNDERREPRESENTED AND EXCLUDED POPULATIONS IN CLINICAL RESEARCH The committee found that the existing research system has served to reduce participation by a diverse population in clinical trials and clinical research through a range of factors, operating at multiple levels. Individual research studies, the institutions that conduct research, funders of studies, institutional review boards (IRBs)
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And while community health centers serve a much more diverse community than academic medical centers, these institutions also face barriers to clinical trials and research recruitment, which, which include limited provider knowledge about available research opportunities and challenges with electronic health record (EHR) infrastructure that can limit providers' ability to query the EHR using study inclusion and ex clusion criteria.
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Research suggests that engaging in mapping to identify all the relevant stakeholders in a community can help study teams develop more equi table study designs and identify individuals and organizations that can help drive the recruitment and retention of diverse study participants. These stakeholders include caregivers, family members, friends, clini cal providers and administrators, community advocates, peers, religious leaders, and political figures.
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Diverse study teams, including study leadership, are helpful to recruit ment and to enhance congruence between research teams and potential participants. It also helps to retain staff over time for recruitment and retention success.
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The clinical research landscape is complex and involves multiple stake holders -- participants, communities, investigators, IRBs, industry spon sors, institutions, funders, regulators, journals, and policy makers. Each of these stakeholders has a critical role to play in achieving the goal of improving representation in clinical research, but the complex nature of the research ecosystem and research processes, combined with lack of ac countability and historic underinvestment, means that an issue that should be everyone's responsibility can become no one's priority.
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RECOMMENDATIONS The committee's recommendations focus on tangible actions that must urgently be taken within the context of the existing structures of the clinical research ecosystem in order to achieve the goals of representation and inclusion. Although individual researchers can take many actions to improve health equity in clinical trials and clinical research, as described in Chapter 5, the committee focused on system-level recommendations to drive change on a broader scale.
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This task force should be charged with the following: a. Producing an annual report to Congress on the status of clinical trial and clinical research enrollment in the United States, includ ing the number of patients recruited into clinical studies by phase and condition; their age, sex, gender, race, ethnicity, and trial location (i.e., where participants are recruited)
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5. Journal editors, publishers, and the International Committee on Medical Journal Editors should require information on the repre sentativeness of trials and studies for submissions to their journals, particularly relative to the affected population; should consider this information in accepting submissions; and should publish this infor mation for accepted manuscripts.
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and the FDA should direct local institutional review boards (IRBs) to assess and re port the representativeness of clinical trials as one measure of sound research design that it requires for the protection of human subjects.
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should ensure that trials provide adequate compensation for research participants. This compensation may include additional reimbursement for expenses including but not limited to lost wages for lower SES participants and family caregiv ers, transportation costs, per diem, dependent care, and housing/ lodging where applicable.
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16. Leaders of academic medical centers and large health systems should provide training in community engagement and in principles of diver sity, equity, and inclusion for all study investigators, research grants administration, and IRB staff as a part of the required training for any persons engaging in research involving human subjects.
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