Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics
Guidance for Industry
In August, the FDA released a Draft Guidance on first-in-human expansion cohorts in oncology trials. This guidance provides FDA’s current thinking regarding:
characteristics of drug products best suited for consideration for development under a multiple expansion cohort trial;
information to include in investigational new drug application (IND) submissions to support the use of individual cohorts;
when to interact with FDA on planning and conduct of multiple expansion cohort studies; and
safeguards to protect patients enrolled in FIH expansion cohort studies.