Diversity in clinical trials comes to the fore

Amid both promising and worrying signs in the development of treatments and vaccines for COVID-19, and in the context of a considerable amount of scrutiny of medical research, some researchers, ethicists, and advocates are working to make sure science doesn’t lose sight of a critical issue: diversity in the clinical trial participant pool.

The distribution of research benefits to participants—and the consideration of race in subject selection—is tightly woven into the Belmont Report and has been a mainstay in research ethics discussion ever since. But despite the decades-long consideration of race and ethnicity in clinical trials, many trials still don’t enroll populations that reflect the diversity of the general populace or the group affected by the condition being studied.

This was the case for COVID-19, for which (as of late August) vaccine trials were underenrolling participants from Black and Hispanic communities.  The linked Washington Post story reports that just a fifth of participants in Moderna’s and Pfizer’s vaccine trials were from those communities. The general population of Black, Hispanic, and Latin American people in the United States constitutes about a third of the country, so to ensure the likelihood that, “any vaccine works for everyone and is broadly accepted,” the trials would need to improve on those figures.

But many claim that simply matching the demographic distribution of the general population is not enough to ensure justice in the presence of staggering racial health gaps in this country, for which COVID-19 is no exception. Study enrollment “should reflect the disproportionate burden of disease, hospitalizations and deaths borne by Black, Hispanic and Native American communities,” according to scientists quoted in the Washington Post story. This standard for participant diversity, rather than matching participant representation to the census standard, can help distribute the fruits of research to the populations most affected.

To ensure diverse participation in trials, enormous community engagement efforts are being made across the country. Recently, STAT featured two vaccine trial recruiters who are working to build trust in science among communities historically underserved by research. The story explores the profound importance and challenges of trust-building between potential trial recruits and the scientific community: one recruiter’s own mother is skeptical of vaccine development, illustrating how pervasive those tensions can be. The American Medical Association has suggested that one way to help diversify the participant pool would be for doctors themselves to participate in trials where possible. Doing so could capitalize on the high level of trust enjoyed by doctors and set a positive example for potential recruited participants.

In early October, Moderna, acknowledging their lagging diversity figures, slowed recruitment to make sure that Black and Hispanic populations (among others) weren’t underrepresented. Several weeks later the Washington Post reported that “Moderna…announced [that] it has fully enrolled its trial, with 30,000 participants—more than a third of whom are minorities.” Moderna’s diversity data was released in a data snapshot available to the public.

What does this all mean for those serving on the IRB? On November 10, in collaboration with the Multi-Regional Clinical Trials (MRCT) Center, PRIM&R will present a webinar entitled The IRB’s Role in Achieving Diversity in Research. Presented by MRCT’s Barbara E. Bierer, MD; David H. Strauss, MD; and Sarah White, MPH, the webinar will explore how the Belmont Report principle of justice lays the groundwork for the IRB’s role in considering and promoting diversity in clinical research. Presenters will also share practical resources for IRBs to use in achieving these goals.