Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 37, No. 3, March, 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.

March 2022 Issue Cover

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Excerpt from pg. 4 … IRBs and Assessment of Benefit-Risk Ratios (#3)

We continue here with more FDA advice for IRBs and others on the assessment of benefit-risk ratios in human subjects research. We resume where we left off last month with FDA’s recommendations on how to handle events that occur in the process of developing a new drug.

“Activities That Occur in Premarket Development That Inform Benefit-Risk Assessment

Decisions and activities undertaken by sponsors in the development of their drugs, and the evidence generated to support their marketing applications, can have a significant impact on the agency’s benefit-risk assessment.

Examples of decisions and activities that may have bearing on a benefit-risk assessment include defining the target patient population, identifying unmet needs for these patients, selecting dose(s) for clinical trials, defining key features of trial design, selecting study endpoints, and incorporating risk-mitigation practices into the clinical trial” (“Benefit-Risk Assessment for New Drug and Biological Products,