Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings

On 24 June 2021 the FDA published this draft guidance for industry. Comments should be submitted by 24 August 2021.

This guidance provides recommendations to clinical investigators and sponsors regarding the inclusion of patients who have not received available therapy (commonly referred to as existing treatment options) for their cancer in clinical trials of drugs and biological products for the treatment of cancer in the non-curative setting. For the purpose of this guidance, non-curative is generally defined as 1) unresectable, locally advanced, or metastatic disease in solid tumors or 2) hematologic malignancies with unfavorable long-term overall survival.

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