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Rare Diseases Clinical Trials Regulation

Patients’ Preferred Endpoints May Not Satisfy Regulatory Needs, US FDA Says

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Executive Summary

Just because a measure is relevant to the patient community does not mean it is capable of capturing meaningful change in a clinical trial, US FDA officials say at a meeting on mitochondrial disease drug development.

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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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