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Rethinking Oncology Development: Master Protocols May Shorten Time To Approval

Master protocols that allow for the simultaneous study of multiple agents will shave more time off in the clinic than one-off studies in small groups of patients, FDA’s Janet Woodcock predicted. The current timeframes in oncology development are “unacceptable,” and can be shortened, she said, by “doing things differently.”

FDA Center for Drug Evaluation & Research Director Janet Woodcock, MD, gave some advice to drug developers looking to shorten the clinical development time for new treatments, particularly in oncology: it will be participation in innovative combination trials that will really cut development time – not simply conducting smaller, shorter studies of single agents.

Woodcock used the platform of an April 12 Friends of Cancer Research forum on Breakthrough Therapies to continue to push for greater adoption of clinical trial master protocols that allow for the simultaneous study of multiple targeted oncology therapies from

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