Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 39, No. 4, April, 2024

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Excerpt from pg. 4 … IRBs and Research With Children (#13)

We present here some more tips for IRBs from then FDA guidance titled “Ethical Considerations for clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry, Sponsors, and Institutional Review Boards.”

We resume with more advice from FDA on features especially relevant in clinical studies with children, particularly studies that involve adults to take advantage of additional adult data.

For indications involving both adults and children, it may be possible to design a single pivotal study that includes both pediatric and adults subjects to reduce the burden of multiple studies and
to optimize the sample sizes for both the pediatric and adult study populations.

Further, while every effort should be made to gather data that adequately address each targeted pediatric subgroup for the proposed indication for use, in some cases, the expected benefit and safety can be determined without separate studies in each subgroup“…