FDA Guidance: Inclusive Cancer Trial Eligibility Criteria

FDA Clinical Trials Guidance

Published April 25th, 2024

Detected March 12th, 2026

Summary

The FDA has issued new guidance recommending that sponsors and institutional review boards expand eligibility criteria for cancer clinical trials to include a wider range of patients, particularly concerning performance status. This aims to improve the diversity of clinical trial populations and ensure broader applicability of cancer treatments.

View original document View source feed page

What changed

The FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have released guidance (Docket Number: FDA-2024-D-1377) aimed at making cancer clinical trials more inclusive. The guidance provides recommendations for expanding eligibility criteria, specifically focusing on performance status, to allow a more diverse patient population to participate. This is part of a series of guidances intended to assist sponsors and institutional review boards in designing trials for investigational cancer drugs.

This guidance is intended for parties involved in the development and oversight of cancer clinical trials, including pharmaceutical companies and trial sponsors. While the guidance itself is non-binding, it offers recommendations for designing trials that better reflect the general patient population. Interested parties can submit comments on the guidance at any time. No specific compliance deadline is mentioned, as this is a recommendation for trial design.

What to do next

Review the FDA's guidance on inclusive cancer trial eligibility criteria.
Consider incorporating recommendations regarding performance status into future clinical trial designs.
Evaluate current trial protocols for potential opportunities to increase participant diversity.

Source document (simplified)

Search for FDA
Guidance Documents

Docket Number: FDA-2024-D-1377 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The purposes of eligibility criteria for cancer clinical trials are to select the intended patient population and reduce potential risks to trial participants. However, eligibility criteria are sometimes more restrictive than necessary, and expanding eligibility criteria to be more inclusive is one trial design consideration that may improve the diversity of clinical trial populations. This guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by CDER and 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 is intended to assist interested parties, including sponsors and/or institutional review boards, who are responsible for the development and oversight of clinical trials.