Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 38, No. 2, Feb., 2023

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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 2023 Issue

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Excerpt from pg. 3 … IRBs and Developing New Drugs to Treat “CDI” (#1)

As we briefly described in the December 2022 HRR’s section titled “IRB Compliance Comment …,” research on CDI (Clostridioides difficile) infection poses special problems for researchers and the IRBs that review the relevant protocols.

CDI is difficult to treat, and potentially fatal. CDI research requires careful subject selection and trial design, among other typical issues to be assessed in IRB reviews.

The FDA’s recent guidance on CDI research, for which the agency is now reviewing compliance community comments, addresses such issues as selection and design, as follows:

Sponsors developing drugs for CDI indications should consider enrolling the following clinical trial populations:

Trials for treatment: Subjects with CDI7 [FN #7: McFarland LV, Elmer GW, and Surawicz CM, 2002, Breaking the Cycle: Treatment Strategies for 163 Cases of Recurrent Clostridium Difficile Disease, Am J Gastroenterol, 97(7):1769-75.]