Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Draft Guidance for Industry, Institutional Review Boards, and Clinical Investigators; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, institutional review boards (IRBs), and clinical investigators entitled "Cancer Clinical Trial Eligibility Criteria: Laboratory Values." This draft guidance is one in a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by the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) for the treatment of cancer. Specifically, this draft guidance includes recommendations for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of diverse trial participants.
Abstract as published in the Federal Register.
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