FDA says open to more flexible clinical trials

WASHINGTON (Reuters) - U.S. regulators are preparing guidelines telling drug makers how they can streamline the testing of experimental medicines by conducting more flexible clinical trials, a top official said on Monday.

The Food and Drug Administration wants to encourage "adaptive" clinical trials that change mid-way through, said Dr. Scott Gottlieb, deputy FDA commissioner for medical and scientific affairs.

The approach is a departure from the rigid structure of most drug studies required for FDA approval in which companies, patients and physicians do not know results until the research is completed. Such "blinding" is usually mandated to keep doctors or patients from acting in a way that could affect a study's outcome.

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