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Wynia M et al. – Regulating clinical trials for testing new drugs is fraught with risk. Misregulation can slow development of innovative and useful new drugs, but in other ways misregulation can foster trials that are inefficient and unethical, driven by commercial rather than scientific ends, and that can harm patients. Data on industry–funded, late–stage clinical trials demonstrate an urgent need for dramatic changes in how these trials are designed, conducted, and analyzed.

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