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# FDA Urges Broader Eligibility for Cancer Clinical Trials
- URL: https://www.fdaweb.com/fda-urges-broader-eligibility-for-cancer-clinical-trials/
- Published: 2026-07-27T12:00:00.000Z
- Updated: 2026-09-14T13:43:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161520

FDA has issued a final guidance encouraging sponsors of oncology clinical trials to broaden eligibility criteria by including more patients with reduced performance status, arguing that less restrictive enrollment could make study populations more representative of patients treated in routine clinical practice. The [guidance](https://www.fda.gov/media/178018/download?ref=fdaweb.com), “Cancer Clinical Trial Eligibility Criteria: Performance Status,” recommends that adult cancer patients with Eastern Cooperative Oncology Group (ECOG) Performance Status 2, or Karnofsky Performance Status scores of 60 to 70, generally be eligible for enrollment unless there is a clear scientific or safety justification for exclusion.

FDA said overly restrictive eligibility criteria can slow patient enrollment, limit access to clinical trials, and reduce the applicability of study findings to the broader population expected to receive approved therapies. The agency noted that including patients with lower performance status can improve understanding of a drug's benefit-risk profile while potentially reducing the need for post-marketing studies.

The guidance also recommends that sponsors re-evaluate performance status criteria throughout drug development as safety data accumulate and consider alternative trial designs, such as dedicated cohorts for patients with poorer performance status. FDA further encourages the use of patient-reported outcomes, digital health technologies, and geriatric assessment tools to complement traditional clinician-assessed performance status measures, particularly for older adults with cancer.