FDA’s Woodcock: ‘The clinical trial system is broken

A BioPharma Dive article

The Food and Drug Administration’s top drug regulator sharply criticized the current clinical trial regime, calling for industry to embrace more collaborative studies.

“I believe the clinical trial system is broken,” said Janet Woodcock, who has worked at the agency for more than three decades, at an industry panel on Nov. 14. “I do not believe it serves the interests of patients.”

Instead, the director for the Center for Drug Evaluation and Research pitched platform trials with master protocols, which she argued can more efficiently answer clinical questions. While this design can require competitors to work together, Woodcock said she has seen a “groundswell” of recent support.

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