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FDA's Gottlieb Critiques Clinical Trial Design

PharmaManufacturing.com

In addressing the recent Conference on Adaptive Trial Design in Washington, D.C., Scott Gottlieb, MD, FDA Deputy Commissioner for Medical and Scientific Affairs, applauded recent progress in the evolution of sophisticated drug development tools. However, he also expressed concern over the design of clinical trials and called for a move toward a more adaptive approach.

http://www.fda.gov/oc/speeches/2006/trialdesign071