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USFDA Guidance: Cancer Clinical Trial Eligibility Criteria – Laboratory Values, Washout Periods and Concomitant Medications, and Performance Status
Appropriate eligibility criteria are essential for protecting trial participants while ensuring that clinical trial populations are representative of patients who are expected to receive the investigational therapy in clinical practice. Overly restrictive eligibility criteria may unnecessarily exclude patients, delay trial enrollment, and limit the applicability of study results. The three FDA guidances—Cancer Clinical Trial Eligibility Criteria: Laboratory Values, Cancer Cli
Sharan Murugan
18 hours ago3 min read