'We just don’t have the studies': New report details critical diversity shortcomings in US clinical research

“We just don’t have the studies” became a familiar refrain for Kirsten Bibbins-Domingo, M.D., Ph.D., chair of the Committee on Improving Representation of Women and Underrepresented Minorities in Clinical Trials and Research.

A new report from the committee shines a light on the “critical shortcoming” in clinical research conducted in the U.S.: a lack of representation in clinical trials. While diversity has become an increasingly important priority in clinical research, racial and ethnic minority populations continue to be left out. Progress has, however, been made when it comes to including a better balance of women to men in research.

Other groups left out include members of the LGBTQIA+ community, older adults, pregnant and lactating individuals and people with disabilities.

Here’s what the committee thinks equitable research looks like: a clinical trial population that matches the demographics of the disease being studied.

The current lack of representation has real consequences: not only does it contribute to the failure of studies to complete, but in the case of the COVID-19 vaccines, the absence of pregnant people in trials led to vaccine hesitancy in this population. Data later revealed that these shots were safe and that vaccination was important for preventing COVID infection in pregnant individuals, but the damage had already been done by the time those findings were revealed.

In another example cited by the report, a phase 2 trial of crenezumab, an Alzheimer’s disease drug under development by Roche’s Genentech, included 360 participants in 83 sites and six countries. Even with its large geographic footprint, the study featured 97.5% white patients and only 2.8% Hispanic. African Americans are two times more likely than white people to be diagnosed with Alzheimer’s and Hispanics one and a half times more likely.

The committee looked at the FDA’s Drug Trials Snapshots data and found that white participation ranged from 84% in 2014 to 74% in 2020—a decrease, sure, but the report said this data also captures increased inclusion of international trial sites. So the real picture in the U.S. may be more stagnant. The data also does not provide any insight into the demographic of the diseases being studied.

So what can be done? The committee has a slate of recommendations for federal agencies, journal editors, Congress, clinical trial sponsors, academic centers, healthcare systems and more. They include a new Department of Health and Human Services task force to examine equity in research and ensure data collection; FDA requirements for recruitment plans when submitting an investigational new drug application or investigational new device exemption application; standardized requirements for the submission of demographic data to the ClinicalTrials.gov database; representation data requirements for journal publications; coverage guidelines from the Centers for Medicare & Medicaid Services that consider representativeness; a congressional requirement for the FDA to enforce accountability and incentive structures; expedited CMS coverage decisions for drugs and devices that were tested in representative populations; compensation by trial sponsors for participation in clinical research, and much, much more.

“Whether you are motivated by the goal of producing the highest quality science, by pursuit of fairness and equity in how science might translate into better health for our patients, or by the enormous economic toll of health disparities in the U.S., I hope you embrace the urgency of improving representation and inclusion in clinical research,” wrote Bibbins-Domingo.