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Draft Guidance on Overall Survival Assessment in Oncology Trials – FDA Oncology
Aug 20, 2025, 18:17

Draft Guidance on Overall Survival Assessment in Oncology Trials – FDA Oncology

FDA Oncology shared a post on X:

“NEW: FDA releases draft guidance on overall survival assessment in oncology trials, with an emphasis on analyzing overall survival as a pre-specified safety endpoint.”

Bishal Gyawali, Associate Professor at Queen’s University and Associate Editor of the Journal of the National Cancer Institute, shared this post, adding:

“Emphasis on overall survival is good, but as a safety endpoint or as an efficacy endpoint? Safety implies we don’t want to see a worse OS. Efficacy implies we want to see improved OS.”

Read further.

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