Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 37, No. 4, April, 2022

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Here’s an inside look at what you will receive in the digital newsletter, including an additional excerpt, below. Click the image below for the first two pages of this issue.

April 2022 Issue Cover

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Excerpt from pg. 3 … IRBs and Expansion Cohort Studies (#1)

We begin this month with coverage of an FDA guidance that affects IRBs and researchers involved in cancer research. The guidance is titled “Expansion Cohorts: Use in First-in-Human [FIH] Clinical Trials to Expedite Development of Oncology Drugs and Biologics.”

This is the final version of a draft that was issued in August of 2018.

The purpose of this guidance is to provide advice to sponsors regarding the design and conduct of FIH clinical trials intended to efficiently expedite the clinical development of oncology drugs, including biological products, through multiple expansion cohort trial designs.

These are trial designs that employ multiple, concurrently accruing, subject cohorts, where individual cohorts assess different aspects of the safety, pharmacokinetics, and antitumor activity of the drug product (Fed. Reg. 11720, March 2).