Drugmakers Balk at Independent Safety Committee Proposal for Expanded Trials

Leading drugmakers are pushing back against an FDA proposal to require independent safety committees for expansion cohorts in clinical trials.

In August, the agency issued a draft guidance that would require first-in-human trials that use multiple expansion cohorts — essentially, open-ended trials that don’t follow the rigid phase I-II-III format — to hire an independent safety or data monitoring committee to do “real time review of all serious adverse events.”

AstaZeneca said the proposed rule would be “burdensome” and that the safety requirement would represent “a significant departure from existing appropriate practice across the industry.”