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

09 Sep 2019

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.

Business_Man_Ceiling — Sponsors may face patient community pressure to use an outcome assessment not well-suited to detecting clinically meaningful change. • Source: Shutterstock

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

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