FDA is announcing the availability of a draft guidance for industry entitled “Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.” The purpose of this draft guidance is to provide advice to sponsors regarding the design and conduct of FIH clinical trials intended to efficiently expedite the clinical development of cancer drugs, including biological products, through multiple expansion cohort study designs. These are study designs that employ multiple, concurrently accruing, patient cohorts, where individual cohorts assess different aspects of the safety, pharmacokinetics, and anti-tumor activity of the drug. This guidance provides FDA’s current thinking regarding: (1) characteristics of drug products best suited for consideration for development under a multiple expansion cohort study; (2) information to include in investigational new drug application submissions to justify the design of individual expansion cohorts; (3) when to interact with FDA on planning and conduct of multiple expansion cohort studies; and (4) safeguards to protect patients enrolled in FIH expansion cohort studies.
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