Despite increased urgency to diversify clinical trials, a majority of NIH-funded trials that had completed enrollment in a recent study missed their diversity targets.
HHS’ Office of Inspector General reviewed a random sample of 30 Phase 3 trials funded by the NIH that enrolled patients between 2016 and 2020. Of the 12 that completed recruitment, 10 enrolled fewer participants than planned from one or more underrepresented groups, OIG announced. In addition, 17 of 30 trials “provided little to no explanation for how they determined their inclusion enrollment targets.”
“This may result in research that does not accurately reflect either disease burdens or the general population, making it difficult to produce generalizable results,” the report states.
NIH noted in a response to OIG that it “determined the proposed population to be scientifically acceptable prior to award” in each of the trials reviewed as part of the study.
OIG made a list of recommendations to NIH, including that the agency hold researchers accountable for “clearly describing” enrollment rationale. OIG also urged the NIH to create an action plan for incorporating new diversity requirements in its data collection. The Office of Management and Budget revised its standards in March to expand minimum categories for collecting race and ethnicity data, among other changes.
Almost 5% of patients enrolled in the sampled trials were classified as an unknown race, and 2% were classified as an unknown ethnicity.
NIH agreed with the recommendations, and committed to creating an action plan by September 2025.
“NIH remains committed to supporting sound science that informs clinical practice and is generalizable across populations and recognizes that ongoing and consistent monitoring facilitates progress and accountability,” the NIH said in its response to OIG.
Democrats on the House Energy and Commerce committee last February also called on FDA Commissioner Rob Califf to provide industry with more guidance on making clinical trials more diverse and inclusive.