Lawmakers, advocates press for diversity in clinical trials

Erin Durkin, National Journal, February 15, 2023

Congress in December enacted new requirements that require drug- and device-makers to ensure there is sufficient diversity in their clinical trials. Yet lawmakers and advocates don’t want to stop there.

Among them is Democratic Rep. Robin Kelly, who plans to reintroduce a bill this month that would require sponsors of research funded by the National Institutes of Health to lay out recruitment goals that reflect the race, ethnicity, age, and sex of patients who have the condition being studied or that reflect the general population of the United States. Republican Rep. Brian Fitzpatrick cosponsored the measure. Republican Sen. Susan Collins and Democratic Sen. Bob Menendez sponsored a companion bill in the Senate.

“Racial and ethnic minorities are not properly represented in clinical research. That’s the bottom line,” Kelly told National Journal.

The proposal aligns with a measure enacted as part of the massive government-funding bill passed at the end of December. That provision requires drug and device sponsors to submit diversity action plans to the Food and Drug Administration. The agency is also required to develop new guidelines or update already existing guidance for these plans.

Kelly said her focus on NIH clinical trials can complement the FDA measures because there are “things that NIH will capture that FDA won’t capture.”


Eyes are now on the implementation of the new requirements for the FDA. Diana Zuckerman, president of the National Center for Health Research, said she is concerned that the new provisions lack teeth but that it is “potentially helpful” that Congress “reminds the agencies that they’re not happy with the lack of diversity.”

Ricki Fairley, cofounder and CEO of Touch, The Black Breast Cancer Alliance, said Kelly’s bill focusing on the NIH is a start, and that “we need more of this.” She said participation in a clinical trial should reflect “the burden of disease.”

“Who is getting this disease, who’s dying from it … that’s who should be in the trials. … Until we get that level of care and support, it’s not going to change,” said Fairley, who works on the campaign When We Tri(al), which aims to get more Black women to enroll in clinical trials for breast-cancer treatments.

“I know I can’t change the mind-set of a health care professional with illicit bias—I can’t change that,” she said. “What I can change—I can talk to Black women, educate Black women, and … teach them how to advocate for themselves.”

Kelly said her bill won’t fully solve the issue of diversity in clinical trials but that “it will take care of some things.” Along with submitting recruitment plans for clinical trials, the measure would require NIH and FDA to conduct a national awareness and educational campaign around the need for diverse clinical trials. She pointed to the use of “trusted messengers” during the COVID-19 pandemic to get people vaccinated.

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