The FDA Needs To Work Harder To Get More Women And Minorities Into Clinical Trials

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Company board rooms, college campuses, and Hollywood sets are all striving for increased racial and gender diversity among their ranks. Most Americans are well aware that those efforts continue to come up short. But there’s one particularly critical area in need of a wider range of diverse participants that may not immediately come to mind: the Food and Drug Administration.

Last week, the Food and Drug Administration (FDA) released a report that you probably didn’t hear about, but that was highly-anticipated among groups advocating for eliminating health care disparities along racial and gender lines. The “Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data” is essentially the FDA’s way of acknowledging that the agency needs to do a better job recruiting different people — particularly women and racial minorities — to participate in the research process for developing new health treatments.

Why does that matter? Because clinical trials are currently dominated by white people, even as non-white Americans have the highest rates of diseases like cancer. In fact, according to one study, non-white people represent fewer than five percent of overall participants in clinical trials, and fewer than two percent of research studies working on cancer treatments focus specifically on minority groups.

This lack of diversity ultimately ends up impacting non-white people’s access to health resources. Since certain drugs and therapies may not work as well for different populations, researchers aren’t necessarily developing the best treatments for the racial groups that need them most. That isn’t purely hypothetical — there’s evidence that the HPV vaccine isn’t as effective for black women because the trials to develop it consisted of mostly white people.

Two years ago, the FDA was tasked with investigating this issue to identify a new way forward. Now, in its new action plan, the agency promises to conduct more research specifically into health issues that impact minorities and work harder to recruit a diverse pool of participants for future studies. “I hope you’ll find that the action plan is responsive and pragmatic and, most importantly, when fully implemented, it will improve medical care and public health,” Margaret Hamburg, the FDA commissioner, wrote in a blog post to announce the new report.

But advocacy groups don’t think the new guidelines go far enough, pointing out that the pharmaceutical industry won’t voluntarily move toward conducting more trials with non-white participants unless the government gets stricter. Without clear consequences — like refusing to approve a new drug unless its clinical trials meet some kind of diversity benchmark — big drug companies will likely have no incentive to actually improve.

“While the FDA Action Plan is a step in the right direction, the agency must do more than remind and encourage industry to include women and minorities in trials and analyze the data,” Cynthia Pearson, the executive director of the National Women’s Health Network, said in a statement. “The FDA must require that companies do this to ensure that that the products women use are safe and effective for them.”

“Gender, race and age play a decisive role in how heart disease, stroke and other forms of cardiovascular disease affect us,” Nancy Brown, the CEO of the American Heart Association, added. “That’s why the FDA must not allow this new plan to just gather dust on a shelf.”

The lack of diversity in research trials has also attracted the attention of Congress. At the beginning of the summer, a group of lawmakers called on the National Institutes of Health (NIH) to make their demographic data on research trials more accessible to the public. They argued that greater transparency in this area would “advance the health of all citizens and address continuing issues with the participation of women and minorities in clinical trials.”