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GUIDANCE DOCUMENT

Approaches to Assessment of Overall Survival in Oncology Clinical Trials Draft Guidance for Industry August 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-5850
Issued by:
Guidance Issuing Office
Oncology Center of Excellence

The purpose of this guidance is to provide recommendations to sponsors on the assessment of overall survival in randomized oncology clinical trials conducted to support marketing approval of drugs and biological products, with an emphasis on the analysis of overall survival as a pre-specified safety endpoint. While the guidance discusses situations in which it is appropriate to consider overall survival for the primary endpoint, this guidance primarily focuses on statistical or design considerations when overall survival is not the primary endpoint. Additionally, this guidance focuses on the assessment of overall survival in randomized trials. 
 

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All written comments should be identified with this document's docket number: FDA-2024-D-5850.

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