Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 37, No. 2, Feb., 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.

February 2022 Issue Cover

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Excerpt from pg. 3 … IRBs and Assessment of Benefit-Risk Ratios (#2)

We continue here with more FDA advice for IRBs and others on the assessment of benefit-risk ratios in human subjects research. The relevant guidance is titled “Benefit-Risk Assessment for New Drug and Biological Products.”

We resume with the agency’s concluding statement from the guidance’s section on the crucial role of uncertainty in weighing benefit-risk ratios.

FDA notes in this regard that it is flexible when it comes to judging whether benefit-risk ratios have been accurately gauged by IRBs and researchers, especially in early Phase 1 studies for rare diseases.

This flexibility means that to be respectful of patients’ willingness to participate in studies, it is important to maximize the potential for such clinical trials to provide interpretable scientific evidence about the drug’s benefits and risks beginning from the earliest stages of drug development