Clinical Trial Diversity ‘Fundamental’ to FDA Mission, CDER Official Says
The need to increase clinical trial diversity was a much-discussed topic at last week’s annual meeting of the Regulatory Affairs Professionals Society (RAPS) in Phoenix, with FDA and industry representatives weighing in.
“The U.S. population is becoming increasingly diverse,” said Mathilda Fienkeng, director of the Center for Drug Evaluation and Research’s Division of Medical Policy Development. “We need meaningful representation in clinical trials. It’s fundamental to FDA’s regulatory mission and overall public health.”
The agency’s own data show the scope of the problem, Fienkeng said.
According to FDA’s 2021 Drug Trial Snapshot, Blacks, Asians and Hispanics are woefully underrepresented in pivotal trials. Said the Snapshot, more than 38,000 people were included in the studies supporting the 50 drugs approved in 2021, but most of these pivotal trials contained fewer than 15 percent Black patients, for example, and many contained no Black, Asian or Latin patients at all. Women and older people also comprised lower percentages.
Minority populations are often excluded from clinical trials without strong clinical or scientific justification, Fienkeng said. Although not overtly intentional, these exclusions reflect the same barriers that separate affluent, largely white populations from the rest of the country’s population groups: community location, financial resources, family responsibilities, and trust of the medical and research communities.
Monique Carter, Pfizer’s senior director of global regulatory strategy, agreed. The company’s 2021 report “Demographic Diversity of Participants in Pfizer Sponsored Clinical Trials in the United States” is a case in point. It examined diversity in 213 Pfizer trials comprising more than 103,000 patients and found that about 60 percent of cardiology, endocrinology, nephrology and hematology trials met the goal of matching trial composition to U.S. Census Bureau data. But overall, therapeutic trials had a higher percentage of white subjects. Black and Hispanic groups were particularly underrepresented in vaccine and oncology trials, said Carter.
“Diversity in clinical trials is the responsibility of the entire medical development ecosystem,” she said. “We are all accountable and must play an actionable role in rebuilding trust in the system if we are to make healthcare disparities a thing of the past.”