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# Ways to Improve OS Data Collection, Analysis
- URL: https://www.fdaweb.com/ways-to-improve-os-data-collection-analysis/
- Published: 2024-07-31T12:00:00.000Z
- Updated: 2026-09-14T14:36:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157475

Researchers from FDA and several other entities say overall survival (OS) remains a critical indication of safety for regulatory decisions and a key aspect of FDA’s Project Endpoint. Writing in *Clinical Cancer Research*, the researchers [say](https://aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-24-0919/746461/Improving-Collection-and-Analysis-of-Overall?searchresult=1&ref=fdaweb.com) it is unfortunate that in the pursuit of earlier endpoints, many registrational clinical trials lack adequate planning, collection, and analysis of OS data, which complicates interpretation of a net clinical benefit or harm.

The article shares best practices, proposes novel statistical methodologies, and provides detailed recommendations to improve the rigor of using OS data to inform benefit/risk assessments. The authors recommend including prospective collection of OS data, establishment of fit-for-purpose definitions of OS detriment, and prespecification of analysis plans for using OS data to evaluate for potential harm in clinical trials intending to demonstrate the safety and effectiveness of a cancer therapy.

“These improvements hold promise to help regulators, patients, and providers better understand the risks and benefits of novel therapies,” the researchers say.