FDA OCE Guidance: Approaches to Assessment of Overall Survival in Oncology Clinical Trials
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.
Comments are due to FDA no later than 20th October 2025
