FDA Guidance: Cancer Trial Eligibility Criteria - Laboratory Values

FDA Clinical Trials Guidance

Published April 25th, 2024

Detected March 12th, 2026

Summary

The FDA has issued new guidance on cancer clinical trial eligibility criteria, specifically focusing on laboratory values. The guidance aims to help sponsors and institutional review boards select appropriate laboratory values to avoid unjustified exclusions of diverse patient populations.

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What changed

The FDA's Oncology Center of Excellence, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research have released guidance concerning laboratory values used as eligibility criteria in cancer clinical trials. The document, identified by Docket Number FDA-2024-D-1402, provides recommendations for selecting laboratory values to ensure that criteria are not unnecessarily restrictive, thereby promoting greater inclusivity and diversity among trial participants. This guidance is intended for sponsors and institutional review boards involved in the design and oversight of cancer drug trials regulated by the FDA.

This guidance offers recommendations for sponsors and institutional review boards to review and potentially revise their clinical trial protocols. The primary implication is to encourage a more inclusive approach to patient selection by critically evaluating laboratory value thresholds that might exclude eligible patients. While the guidance is non-binding, adherence is encouraged to improve trial diversity. Interested parties can submit comments on the guidance at any time via the regulations.gov portal or by mail, referencing the docket number FDA-2024-D-1402.

What to do next

Review current cancer clinical trial protocols for laboratory value eligibility criteria.
Consider FDA recommendations to ensure criteria are not unnecessarily restrictive and promote patient diversity.
Consult the guidance document for specific recommendations on laboratory value selection.

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Guidance Documents

Docket Number: FDA-2024-D-1402 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 for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of diverse trial participants. This guidance intends to assist interested parties, including sponsors and/or institutional review boards, who are responsible for the development and oversight of clinical trials.