Regulatory Focus - Clinical trial diversity: FDA pushes real-world evidence, diffusion of trial sites
Real-world evidence, post-marketing studies, and migrating clinical trial sites into underserved communities are all strategies the U.S. Food and Drug Administration (FDA) is pushing to help increase data on the outcomes of minority patients, according to Amy Abernethy, MD, PhD, the agency’s principal deputy commissioner.
“There is real a gap between the makeup of our American public and the representation of our Black community and Black women in clinical trials,” Abernethy said. “That’s because I think we’ve done a poor job across time making sure that we address critical questions like Tuskegee and Henrietta Lacks, full stop. I think it’s also because we’ve done a poor job in the past – and hopefully are starting to fix this – at providing the kind of information and communication to help people know why and how to participate in clinical trials.”
Abernethy made her comments at a forum aimed at increasing Black women’s participation in cancer clinical trials, sponsored by Project TEACH (Trained Empowered Advocates for Community Health). Project TEACH is a collaboration between the Black Women’s Health Imperative, Friends of Cancer Research and Stand Up To Cancer that trains patient advocates to engage with researchers and clinicians with the goal of increasing clinical trial participation.
Forum organizers pointed to the current lack of representation of minorities in clinical trials for cancer treatments. An analysis by ProPublica of FDA data found that for trials of 24 of 31 cancer drugs approved since 2015, fewer than 5% of the trial participants were Black. These gaps are especially harmful in cancers where Black women are disproportionately affected.
“Black women are twice as likely, compared to White women, to have a particularly aggressive form of breast cancer, known as triple negative breast cancer,” said Lisa A. Newman, MD, chief of the section of breast surgery at Weill Cornell Medicine in New York. “We have ongoing research, that is very exciting, in learning more about these genetic causes of triple negative breast cancer related to African ancestry and this work will be important for everybody.”
But the limited participation of Black women in clinical trials means that the picture of how triple negative breast cancer affects women is “too narrow,” Newman said. “We absolutely need to have more African American women on these clinical trials.”
Abernethy pointed to the FDA’s most recent effort to improve diversity in clinical trials – final guidance for trial sponsors, issued in November 2020, that calls for broadening enrollment criteria and avoiding unnecessarily excluding participants (RELATED: FDA lays out strategies for promoting diversity in clinical trial enrollment, Regulatory Focus 09 November 2020).
“We also said, we can’t just conduct trials, for example, in academic sites or big cities. We actually have to take clinical trials to where people are, so that as a Black woman you have the opportunity to have a clinical trial with your doctor because this is where you get your care,” Abernethy said.
Other avenues outside of trials can yield important data on the outcomes of minority patients, Abernethy said. These include real-world data sources, like electronic health records and administrative claims data, as well as post-marketing studies and safety monitoring.
“As people start to get access to a new drug we should be learning from the story of each person,” she said. “By using data that is collected in real-world settings… we can start to fill in that information gap to create a more inclusive picture of how a medical product performs for everyone.”
But Abernethy acknowledged that the medical and research community has an uphill climb to earn the trust of minority patients so that they will want to participate in clinical trials.
“I think we have a lot of work to do to really get to the place of building that trust for the Black community overall, and really for all Americans,” she said.