Health Equity Summit: Conversations on Representation in Clinical Trials

Disparities in clinical trials and the under-representation of certain groups in research studies has been a long-term, ongoing challenge for many years in the United States. In a recently published study on 230 vaccine clinical trials from 2011-2020 involving more than 290,000 participants, researchers found an over-representation of White  participants (78%), while historically under-represented groups—Blacks, Latinx, Asians, Native Americans, females, and adults older than age 65—participated in remarkably low numbers, demonstrating that disparities in clinical trial access are not a thing of the past.

The Alliance for Health Policy (AHP), a nonprofit group dedicated to health policy education, recently presented its 2021 Signature Series on practices and policies that enable existing inequities in society today. Tanisha Carino, PhD,  executive vice president and chief corporate affairs officer of Alexion Pharmaceuticals, hosted the "Spotlight Conversations on Equity in Health Care" discussion, which illustrated the need for diversity in clinical trials to create an equitable research environment and to build trust in science, medicine, and public health communication.

Guest speaker Yasmeen Long, a director at FasterCures—a Washington, D.C.-based, nonprofit think tank focused on accelerating medical research—studies health disparities, equity, health outcomes, policy, clinical research, and social determinants of health. She addressed several key points regarding the decades-long, multigenerational legacy of mistrust that exists within research studies, particularly among, but not limited to, specific racial and ethnic groups. Such mistrust, according to Long, leads to a lack of diversity in biomedical research and innovation: "We lose the potential impact of research outcomes and new innovations because if the research lacks representation from under-represented groups, then the outcomes of that research will be limited to how wide that net is cast."

Long urged leaders in health policy and biomedical research and innovation to address health equity as a call to action to enact change in the culture of health systems and in public policy. A sense of urgency to address this inequity currently exists, Long suggested, because "a lack of trust is a key component [that] often discourages some racial and ethnic minority groups from seeking or participating in clinical trials.” By not including more under-represented communities and populations within the health innovation and research space, said Long, “we lack equity in how that research is conducted and in the standard processes and operating procedures needed to conduct that research." For instance, by diversifying the research workforce and providing an atmosphere in which researchers and providers resemble the community they are studying, the potential for building trust within historically under-represented communities can encourage those same communities to participate and engage in more clinical trials.

Although clinical trials have been used for decades to determine the safety and efficacy of drugs and medical devices, the lack of a diverse population in such studies has failed to represent the population suffering the burden of the diseases being studied, therefore impacting how products are developed for the health consumer. As such, research studies must represent this diversity so that treatments and therapeutics are safe and effective to use for a larger portion of the population.

In clinical research, poorly represented populations not only include ethnic minorities, but also other historically under-represented groups, including "older adults, pregnant and lactating women, people with limited access to technology, rural populations, people with rare diseases, female gender, [a diverse] gender identification, and people with limited or low health literacy," explained Long. In thinking about equity in clinical trials and research studies, she added, these considerations are key in determining how to diversify and have more representation in research studies, and how that can ultimately lead to policy development and change.

Learn more about ACCC’s efforts to promote the inclusion of traditionally marginalized groups in clinical trials:

• ASCO-ACCC Initiative to Increase Racial and Ethnic Diversity in Clinical Trials
• Webinar: In Pursuit of Equity: Diversity in Clinical Research Participation
• Article: Center for Indigenous Cancer Research at Roswell Park Comprehensive Cancer Center
• Podcast: Advancing Clinical Trial Equity
• Podcast: Clinical Trial Access in Rural Areas
• Blog: New Legislation Expands Access to Clinical Trials