GUIDANCE DOCUMENT
Cancer Clinical Trial Eligibility Criteria: Laboratory Values Draft Guidance for Industry, IRBs, and Clinical Investigators April 2024
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2024-D-1402
- Docket Number:
- FDA-2024-D-1402
- Issued by:
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Guidance Issuing OfficeOncology Center of ExcellenceCenter for Drug Evaluation and ResearchCenter 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.