Cancer Clinical Trial Eligibility Criteria: Laboratory Values Guidance for Industry, IRBs, and Clinical Investigators July 2026

GUIDANCE DOCUMENT

• Docket Number: FDA-2024-D-1402
• Issued by: 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 subjects. However, eligibility criteria are sometimes more restrictive than necessary, and expanding eligibility criteria to be more representative is one trial design consideration that may improve the applicability of clinical trial data to U.S. 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, although many of the concepts may apply more broadly to other clinical areas. Specifically, this guidance includes recommendations for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of trial subjects. This guidance intends to assist interested parties, including sponsors, clinical investigators, and institutional review boards (IRBs), who are responsible for the development and/or oversight of clinical trials. 

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