Justice for All: Diversity in Clinical Trials

The COVID-19 pandemic has brought to light, once again, the ongoing issue of racial health inequalities in the United States and around the globe. As the first vaccines and treatments for COVID-19 were being approved for use around the world, scrutiny of medical research and its oversight highlighted the fact that there is still much to do to resolve the unending epidemic of racism in healthcare and to ensure diversity in clinical trials.

In the United States, in spite of the awareness of the problem of race and diversity in clinical trials, populations enrolled in clinical trials often do not reflect the diversity of the general population or the group affected by the condition being evaluated.

For example, Jonathon Kimmelman’s discussion in the 2020 Advancing Ethical Research Conference (AER20) panel, Scientific and Ethical Challenges of COVID-19 Prevention Trials in a Complex Sociopolitical Context, highlighted the fact that while COVID-19 case and death rates are more than two times higher among African Americans, Black research participants only represented 11%, 6%, and 2% of the subject pool in the Remdesivir (Gilead Sciences treatment option), Bamlanivimab (Eli Lilly and Company treatment option), and Pfizer BNT162b1 vaccine phase 1/2 trials, respectively.

While the research community is aware of this ongoing issue, it can be difficult to navigate how to impact change, especially in times of emergency. Is it more beneficial to obtain safety and efficacy data as soon as possible to get the product out? Should trial progress be slowed, not only to ensure diversity in clinical trials, but to ensure scientific validity? And how can investigators be sure a product will affect the general population similarly, if the research subject pool does not reflect the general population?

There are signs, though, that researchers are starting to address the issue of diversity in clinical trials. Recruitment for Moderna’s Phase 3 COVE Study of mRNA-1273 was slowed in October of 2020 to address the lack of diversity in that study’s enrollment. As a result, after enrollment was complete, 37% of subjects identified as minorities. IRBs can suggest at the time of review that diversity be acknowledged, but it ultimately falls upon the sponsors and investigators to ensure diversity in clinical trial research subject pools.

This is a difficult issue, exacerbated by a long history of research abuses directed towards minorities and enduring inequalities in healthcare. What else could happen to build trust between the research community and prospective study subjects? Investigators might think about participating in the process. Potential subjects might be more willing to participate in a trial if study investigators also showed their willingness to do so.

And acquiring the trust of potential subjects and ensuring diversity in clinical trial development is only part of the process. The Belmont Report’s ethical principle of Justice, raises questions about both who might bear the burdens of research and ensuring the benefits of research are equitably distributed. Minorities and communities historically underserved by research also have been disproportionally affected by the COVID-19 pandemic. After product approvals are in place, how can these treatments and preventatives be distributed to the populations most affected? Because, currently, Black Americans are getting vaccinated at lower rates than white Americans.

I am interested to hear thoughts on how we, as IRB professionals, can work to address this issue in research.

Ed. Note: PRIM&R hosted a webinar on this topic February 18 – The Colors of COVID-19: Embracing the Novel Ethical Challenges and Opportunities in COVID-19 Vaccine Trials. A recording of this webinar is available in the Knowledge Center.

Gretchen ParkerGretchen Parker, PhD, RAC, CIP, serves as co-chair for Pearl IRB and provides regulatory and clinical research support services for clients. Throughout her career, she has been deeply involved in regulatory affairs, clinical research, and medical writing for the pharmaceutical and medical device industries. She led the AAHRPP accreditation efforts at Pearl IRB and has assisted FDA inspectors on-site. She also led the efforts to update Pearl IRB institutional policies and procedures to comply with the revised Common Rule.

Dr. Parker began her career as a Regulatory and Compliance Analyst at a consulting firm, where she worked with clients, ranging from biotech start-ups to Fortune 500 companies, to plan and implement regulatory strategies, submissions, and research protocols. Her duties engaged her with several US governmental agencies, including FDA, USDA, and EPA.

Dr. Parker received a PhD in Molecular Endocrinology and Biochemistry from Purdue University, and completed her Post-Doctoral Fellowship in Biochemistry and Molecular Biology at the Indiana University School of Medicine Center for Diabetes Research. She has authored and published dozens of scientific articles in major peer-reviewed journals, holds a patent for a diagnostic assay, and is a member of PRIM&R and AAHRPP. She is Regulatory Affairs Certified (RAC) and a Certified IRB Professional (CIP).

Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.