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# Cancer Trial Performance Status Eligibility Criteria
- URL: https://www.fdaweb.com/cancer-trial-performance-status-eligibility-criteria/
- Published: 2024-04-25T12:00:00.000Z
- Updated: 2026-09-14T14:29:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156853

FDA has published a draft guidance, *Cancer Trial Eligibility Criteria: Performance Status*, with recommendations for expanding eligibility criteria to include patients with a wide range of performance status in clinical trials of investigational cancer drugs regulated by CDER and CBER. The [document](https://www.fda.gov/media/178018/download?ref=fdaweb.com) is one in a series of guidances with recommendations on various eligibility criteria for the drug trials, aimed at expanding eligibility criteria and improving the diversity of trial participants.

Performance status, a measure of how well a patient can perform ordinary tasks and carry out activities of daily living, is one of the most common eligibility criteria in oncology trials, FDA says. It says many trials are limited to “high-functioning” patients and thus exclude “low-functioning” patients.