FDA Guidance: Cancer Trial Eligibility Criteria

FDA Clinical Trials Guidance

Published April 25th, 2024

Detected March 12th, 2026

Summary

The FDA has issued new guidance regarding eligibility criteria for cancer clinical trials, specifically addressing washout periods and concomitant medications. This guidance aims to help sponsors and IRBs develop trials that are inclusive while ensuring participant safety. Comments on the guidance can be submitted at any time.

View original document View source feed page

What changed

The FDA's Oncology Center of Excellence, in conjunction with CDER and CBER, has released new guidance (Docket Number: FDA-2024-D-1376) concerning eligibility criteria for cancer clinical trials. The document provides recommendations on the appropriate use of washout periods and the exclusion of concomitant medications. The stated purpose is to assist sponsors and institutional review boards in designing trials that are more inclusive, thereby improving the diversity of clinical trial populations, while still selecting appropriate patient populations and mitigating risks.

This guidance is intended for sponsors and institutional review boards involved in the development and oversight of cancer clinical trials. While the guidance is non-binding, it offers recommendations that may influence trial design and protocol development. Regulated entities should review the guidance to understand current FDA recommendations on washout periods and concomitant medications to ensure their trial designs are aligned with agency expectations, potentially leading to broader patient eligibility. Comments can be submitted to the FDA at any time via the regulations.gov portal.

What to do next

Review FDA guidance on washout periods and concomitant medications for cancer clinical trials.
Assess current and future cancer trial protocols for alignment with the new guidance.
Consider incorporating recommendations to enhance patient eligibility and trial diversity.

Source document (simplified)

Search for FDA
Guidance Documents

Docket Number: FDA-2024-D-1376 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 or biological products regulated by CDER and CBER for the treatment of cancer. Specifically, this guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions. 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.