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 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. Some committee members, however, expressed concern that requiring randomized trials, even postapproval, would yield suspect data, as treatments for small population groups would need to be expanded to different populations.
Washington Drug Letter