Federal Register #2026-15186

FDA Final Guidance on Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has released a final guidance document for stakeholders involved in cancer clinical trials. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Purpose: - Provides recommendations for eligibility criteria in cancer clinical trials, specifically addressing washout periods and the use of concomitant medications - Aims to assist industry sponsors, institutional review boards (IRBs), and clinical investigators in designing and reviewing protocols - Key Details: - Focuses on investigational drugs for cancer treatment - Emphasizes patient safety and data integrity in trial design - Finalizes a previously issued draft guidance - No procurement activity: - No products, services, OEMs, or vendors are being requested or procured - No contract or acquisition is associated with this announcement

Description

The Food and Drug Administration (FDA) has announced the availability of a final guidance document for industry, institutional review boards (IRBs), and clinical investigators. This guidance provides recommendations on eligibility criteria for cancer clinical trials, specifically focusing on washout periods and exclusions for concomitant medications. It aims to assist sponsors, IRBs, and investigators in designing and reviewing clinical trial protocols to ensure patient safety and data integrity. The guidance finalizes a draft issued on April 26, 2024, and is part of FDA's efforts to clarify eligibility criteria for cancer trials.

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