FDA implements single-pivotal-trial policy; clinical trial diversity advocates flag Black Americans' 8.5% oncology enrollment gap

The FDA formally implemented its single-pivotal-trial policy in March 2026, with the first drugs reviewed under the new standard entering the approval queue. Simultaneously, clinical trial diversity advocates drew attention to a compounding risk: Black Americans represent only 8.5 percent of oncology clinical trial enrollees despite comprising 14.6 percent of the U.S. population — a gap that a single, smaller trial makes statistically harder to detect and correct. Under the two-trial standard, a second independent trial could flag subgroup safety or efficacy differences missed in the first; the single-trial default eliminates that structural check. The FDA's Diversity Action Plan requirements remained in effect but lacked mandatory enrollment targets.