Federal Register #FDA-2024-D-1402

FDA Guidance on Laboratory Values for Cancer Clinical Trial Eligibility

This announcement from the Food and Drug Administration (FDA) provides new guidance for cancer clinical trial eligibility criteria: - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - No Original Equipment Manufacturers (OEMs) or vendors are mentioned - No products or services are being procured - Key Details: - The guidance document is titled "Cancer Clinical Trial Eligibility Criteria: Laboratory Values" - Intended for industry, institutional review boards (IRBs), and clinical investigators - Offers recommendations for selecting laboratory values as eligibility criteria in cancer clinical trials - Aims to prevent unjustified exclusion of participants from trials - Part of a series of guidances for investigational drugs regulated by CDER and CBER - Focuses on improving inclusivity and trial design in clinical research - No procurement action, contract, or purchase is associated with this notice

Description

The Food and Drug Administration (FDA) announces the availability of a final guidance for industry, institutional review boards (IRBs), and clinical investigators titled "Cancer Clinical Trial Eligibility Criteria: Laboratory Values." This guidance provides recommendations for selecting appropriate laboratory values as eligibility criteria in cancer clinical trials to avoid unjustified exclusions of trial participants. It is part of a series of guidances related to eligibility criteria for clinical trials of investigational drugs regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation Research (CBER). The guidance finalizes the draft issued on April 26, 2024, and aims to assist sponsors and IRBs in developing and overseeing clinical trials.

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