Cancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability
Published Date: 7/28/2026
Notice
Summary
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled "Cancer Clinical Trial Eligibility Criteria: Performance Status." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation Research (CBER) for the treatment of cancer. Specifically, this guidance includes recommendations regarding expanding eligibility criteria to include patients with a wider range of performance status. This guidance finalizes the draft guidance of the same title issued on April 26, 2024.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
Broader Cancer Trial Eligibility
If you have cancer, FDA's final guidance recommends expanding clinical trial eligibility to include patients with a wider range of performance status. The guidance was finalized July 28, 2026 and finalizes the April 26, 2024 draft; it aims to reduce restrictive rules that can limit patients' access to clinical trials.
Trial Design Burden on Sponsors
FDA's final guidance notes that including patients with lower performance status can affect trial retention and required sample size. Sponsors and Institutional Review Boards should consider these impacts when designing trials, as highlighted in the finalized guidance published July 28, 2026.
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The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications." This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation Research (CBER) for the treatment of cancer. Specifically, this draft guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions. This guidance finalizes the draft guidance of the same title issued on April 26, 2024.