FDA Carrots And Sticks Are Best Way To Get Subgroup Data, Advocates Say

Stakeholders tell FDA it should force sponsors to recruit more diverse populations for its clinical trials by refusing to approve applications with inadequate data or expediting those with the necessary information.

Stakeholders and advocates want FDA to impose the ultimate penalty and withhold approval of an application when the sponsor does not gather the necessary subgroup data in the clinical trials.

The agency also could offer a reward by expediting review for sponsors that comply with efforts to increase patient diversity...