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FDA developing new guidance for adaptive clinical trials

Pharma Compliance Alert, July 12, 2006

The FDA is working on a series of guidance documents for developing adaptive approaches to clinical trials, according to FDA Deputy Commissioner Scott Gottlieb's prepared remarks at the 2006 Conference on Adaptive Trial Design in Washington, DC. Unlike large, blinded clinical trials which keep study results secret until they're complete, adaptive trials allow studies to change as they take place. According to Gottlieb, adaptive trials have the potential to be shorter and less costly, may expose fewer people to experimental treatments, and could reveal more about the safety and benefits of drugs.

The FDA's guidance will cover up to five topics, such as how to look at multiple endpoints in the same trial and how to deal with missing clinical trial data. The FDA will also participate in a two day workshop in November to discuss adaptive design issues and has established special teams to provide consults to divisions considering an adaptive trial design.

Read all of Gottlieb's prepared comments here.

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