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# Group Outlines Considerations for OS Analyses
- URL: https://www.fdaweb.com/group-outlines-considerations-for-os-analyses/
- Published: 2024-07-23T12:00:00.000Z
- Updated: 2026-09-14T14:36:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157413

Experts from FDA, the American Association for Cancer Research (AACR), and the American Statistical Association (ASA) have published considerations for clinical trial designs to enhance the collection and analysis of overall survival data in the context of modern-day cancer treatments. The work was [published](https://aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-24-0919/746461/Improving-Collection-and-Analysis-of-Overall?ref=fdaweb.com) in *Clinical Cancer Research*.

An American Society of Clinical Oncology [statement](https://ascopost.com/news/july-2024/aacr-asa-fda-outline-considerations-for-overall-survival-analyses-in-clinical-trials/?ref=fdaweb.com) says the usefulness of overall survival as a metric of a cancer drug’s safety and efficacy has become difficult in recent decades due to the progress made in the treatment of many cancers. The statement says the study was built on discussions from an FDA-AACR-ASA 7/2023 workshop on overall survival in oncology clinical trials. Attendees at the workshop discussed how unequal randomization, crossover from one trial arm to another, subsequent lines of therapy, subgroup considerations, and adverse effects might affect the interpretation of overall survival.

“The focus on overall survival is often as an efficacy endpoint in oncology clinical trials, but overall survival is also an important safety endpoint,” said FDA Oncology Center of Excellence Endpoint Development associate director **Nicole Gormley**, the co-study author. “Prespecified statistical analyses of overall survival as a safety endpoint can provide valuable information on a product’s benefit/risk profile when relying on earlier endpoints such as progression-free survival or overall response rates. Robust assessments of overall survival as a safety measure are critical for FDA’s use of earlier endpoints to support approval.”