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Clinical Trials FDA Regulation

Cancer Trials: US FDA Expands Scenarios Where Placebo Design Needs Justification

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Executive Summary

Sponsors should justify use of a placebo control when primary adverse event prophylaxis is required, there exists an available therapy, or when placebo is given as monotherapy, agency says in final guidance applicable to randomized controlled oncology trials.

 

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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