Hamburg seeks something better than randomized trials for drug approvals

FDA Commissioner Margaret Hamburg wants to strengthen "a weak link in the chain" between science and drug regulation: the plodding randomized clinical trial. She'd like to see university-based centers of excellence working on new approaches to drug approvals. Among such approaches are adaptive trials with their provision for modifying a study under way in response to interim findings. It's part of Hamburg's effort to advance regulatory science, as described in a proposed framework for FDA's regulatory science initiative. Article

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