Advisory Committee Calls for Randomized Trials in Accelerated Approvals

Drugmakers conducting postmarket clinical trials should be required to conduct randomized trials, according to the FDA’s Oncologic Drugs Advisory Committee. The committee, which met Tuesday to discuss planning and conduct of postmarketing studies to confirm benefit of new drugs and biologics under accelerated approval, focused heavily on the studies required to gain accelerated approval in the first place. The committee agreed almost unanimously that randomized trials, as opposed to single-arm studies, should be the default position for granting accelerated approval to new drugs and indications.
Drug Industry Daily