Federal Register #FDA-2024-D-1377

FDA Final Guidance on Cancer Clinical Trial Eligibility Criteria for Performance Status

This notice announces the release of a final guidance document by the Food and Drug Administration (FDA) regarding cancer clinical trial eligibility criteria for performance status. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Centers: Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) - Purpose: - Provides recommendations for industry sponsors, Institutional Review Boards (IRBs), and clinical investigators - Focuses on expanding eligibility criteria in cancer clinical trials to include patients with a broader range of performance status - Aims to improve inclusivity and better represent the intended patient population in cancer drug trials - Notable Details: - This is a regulatory guidance notice, not a procurement or solicitation - No OEMs, vendors, products, or purchase quantities are mentioned - Finalizes a previous draft guidance as part of FDA's efforts to enhance clinical trial design and inclusivity

Description

The Food and Drug Administration (FDA) announces the availability of a final guidance for industry titled "Cancer Clinical Trial Eligibility Criteria: Performance Status." This guidance provides recommendations for expanding eligibility criteria in cancer clinical trials to include patients with a wider range of performance status. It finalizes the draft guidance issued on April 26, 2024, and aims to improve clinical trial inclusivity by broadening patient eligibility. The guidance is intended for sponsors, Institutional Review Boards, and clinical investigators involved in cancer drug trials regulated by CDER and CBER.

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