The U.S. Food and Drug Administration (FDA) has issued a new draft guidance aimed at increasing diversity and representation of underrepresented racial and ethnic populations in clinical trials. This move is a significant step toward ensuring that the treatments and therapies approved by the FDA are effective and safe for all segments of the population, including Black Americans. BDO executive editor Jade Curtis hosted a conversation with esteemed individuals, in partnership with the NIH’s Cancer Moonshot, on what this draft guidance means for Black Americans and future drug approvals.
Historically, clinical trials have often failed to adequately represent the diversity of the U.S. population, leading to potential disparities in the efficacy and safety of approved treatments for certain groups. By mandating that clinical trial sponsors submit demographic data on trial participants, the FDA hopes to address this issue and promote greater inclusivity in medical research.
“The reason that this is so important is because as a doctor, if [a patient] comes into my office and they’re Black, for example, and [a clinical] trial was done only in white people, then it’s gonna be hard for me to say with a 100 percent certainty, ‘Yes, this treatment is gonna work exactly the way it was studied,'” explained Dr. Kamal Menghrajani, a physician and member of the White House Office of Science and Technology Policy.
While the FDA’s mandate is a positive step, there are still barriers that prevent many individuals from participating in clinical trials. These include logistical challenges such as transportation, childcare, and time off from work, as well as historical mistrust and a lack of awareness about clinical trials within certain communities.
“We cannot ask people to come to sites that are an hour to an hour and a half away, in the middle of the day when the communities that we are trying to bring awareness to recruit for studies have jobs where they can’t leave in the middle of the day to drive an hour and a half to enroll in the clinical trial,” said Perla Nunes, a longtime clinical research advocate.
To address these issues, the experts suggest that clinical trial sites should be established in more accessible locations, such as community health centers and public health departments. Additionally, increasing the diversity of principal investigators and allowing for multilingual enrollment can help build trust and encourage participation from underrepresented groups.
Effective community engagement is crucial for increasing clinical trial participation among underrepresented populations. This includes acknowledging historical injustices, building long-term relationships with community organizations, and providing transparent information about the clinical trial process.
“You have to bring awareness and education about what clinical trials are. There’s a lot of myths out there, and we need to let people know about the pros and cons,” said Nunes. “You don’t have to be sick to participate in a clinical trial. Clinical trials need healthy volunteers as well.”
Patient advocates like Wenora Johnson, a three-time cancer survivor, also emphasize the importance of self-advocacy and open communication between patients and their healthcare providers. “It begins with communicating with the patient about opportunities of additional forms of treatment that are out there,” Johnson said.
In addition to community engagement efforts, the FDA and other organizations are exploring ways to make clinical trials more accessible to a broader range of participants. This includes initiatives such as partnering with retail pharmacy chains like Walgreens to establish clinical trial sites in more convenient locations.
“The administration is thinking a lot about how to do this and actually just announced a $100,000,000 partnership between BARDA, the Biomedical Advanced Research and Development Authority, and Walgreens,” said Dr. Menghrajani.
While the FDA’s diversity action plan represents a significant step forward, achieving true inclusivity in clinical trials will require sustained effort and collaboration among various stakeholders, including research institutions, patient advocacy groups, and communities themselves.
As Nunes stated, “I’m just really hopeful, and I always look at the glass half full. So I’m very hopeful that, when the final mandate comes out, which I’m hoping will be at the end of this year or early, 2025, we will see that our communities are being represented, but we still need a lot of work in going into the communities and talking about what are clinical trials.”
By addressing the barriers to participation and fostering trust and open communication, the medical research community can work towards ensuring that the treatments and therapies developed through clinical trials truly benefit all segments of the population.
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