IDDI Comment on the FDA Draft Guidance on Expansion Cohorts

FDA Draft Guidance for Industry on the Use of Expansion Cohorts

IDDI has submitted a comment on the Food and Drug Administration (FDA) recent Draft Guidance for Industry regarding the use of expansion cohorts in first-in-human clinical trials.

Read full Comment HERE: The purpose of IDDI comments is to emphasize the need to consider randomization whenever feasible in expansion cohorts, even though randomization has rarely been used until now in this setting. Our view is that the use of a randomized control group should be considered when designing any clinical trial, including an expansion cohort, in order to produce an unbiased assessment of a drugs efficacy.

Read FDA draft guidance HERE: The purpose of this draft guidance is to provide advice to sponsors regarding the design and conduct of first-in-human (FIH) clinical trials intended to efficiently expedite the clinical development of cancer drugs, including biological products, through multiple expansion cohort study designs.

• Open document on Regulations.gov: 

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