Drugs Approvals by FDA do not Require Diversity in Clinical Trials
[Thursday, September 5, 2019]

Over the last 10 years, most clinical trials used to support approval of anti-cancer drugs lacked diversity in the trial population with only about 10% including reasonable participation by the four major races – whites, blacks, Hispanics, and Asians – and only about 25% conducting race subgroup analysis to evaluate demographic effect of treatment outcome. But apparently, lack of diversity did not affect the approval decision for these new drugs. While diversity in trial populations is desired, the challenge to recruit diverse populations in clinical trials is a well-accepted and regulators seemingly don’t hold it against the sponsors for their inability to recruit diverse populations. White participants represent more than 75% of the trial population, while Blacks and Hispanics comprise about 3 and 6 percent of the study populations, respectively. Asians, on the other hand, are over-represented in the trial populations compared to their proportion of the overall population composition, with about 18% of the clinical trial participants being Asian. The demographic distribution of clinical trial populations obviously is quite different from that of the US population and there seems to no change in the trends despite FDA’s efforts over the same period. While it is tempting to criticize FDA for not enforcing its stated goal of seeking diverse clinical trial population and race subgroup analysis in market approval applications, there is no legal or statutory basis for FDA to reject applications solely based on lack of diversity. So long as the trial included sites in the US, FDA cannot reject data generated at those sites even if the demography of recruited subjects is non-diverse. There is need for better outreach and education in minority communities, particularly black and Hispanics, to encourage participation in clinical trials. At the same time, sponsors have to only show that they tried; FDA will not likely not hold lack of diversity against them.