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Home » FDA Releases First in Series of Guidances on Cancer Trial Endpoints
FDA Releases First in Series of Guidances on Cancer Trial Endpoints
April 1, 2005
The most reliable method for demonstrating the efficacy of a cancer drug or biologic is to show a statistically significant improvement in a clinically meaningful endpoint in blinded, randomized, controlled trials, but there are single-arm study approaches that might be successful in certain settings, explains a new FDA draft guidance.