BIO Comments on FDA Draft Guidance on Use of Expansion Cohorts in First-In-Human Clinical Trials
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.
BIO welcomes FDA’s efforts to provide clear guidance on the regulatory and scientific framework for designing and conducting adaptive trial designs in which different aspects of a drug can be assessed in a single clinical trial while enrolling the minimum number of study participants necessary.
BIO’s comments cover topics including sample sizes, the need for flexibility, and balancing safety and efficacy. BIO encourages the FDA to consider expanding the use of the guidance beyond oncology.