Gottlieb Targets More Efficient Clinical Trials

September 14, 2017

FDA commissioner Scott Gottlieb highlighted the agency’s efforts to improve clinical trials during a keynote address Monday at the RAPS’ 2017 Regulatory Conference.

Gottlieb said the agency wants to encourage the use of new tools in clinical trial design, including the addition of specific patient characteristics.

He noted the proliferation of combined phase or “seamless” trials, in which sponsors conduct one adaptive study in place of separate, phased trials. The seamless trials are well-suited to drugs that work across a broad swath of diseases, he said.

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