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Committee: Randomized Trials Needed for Accelerated Approvals

February 22, 2011
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 Feb. 8 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. While 27 of the 29 approvals granted on the basis of single-arm studies required postmarket randomized trials, the committee agreed almost unanimously that randomized trials should be the default position for granting accelerated approval to new drugs and indications.
Clinical Trials Advisor