FDA guidance on clinical trial endpoints

24 October 2023

By Dr Nicola Davies

In October 2022, the US Food and Drug Administration (FDA) released its “Multiple Endpoints in Clinical Trials” document to provide guidance for drug sponsors and other stakeholders regarding best practices in assessment methodologies for medications.

A year on and with an upsurge in novel endpoints, we refresh on the key outcomes being sought by the agency and the reasons for their importance.

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