FMT and Microbial Medical Products: Generating High-Quality Evidence through Good Governance

Journal of Law, Medicine and Ethics 47 (4):505-523 (2019)
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Abstract

This article argues that current data for the safety and efficacy of fecal microbiota transplants as a treatment for any indication, including recurrent Clostridioides difficile infection, is low-quality. It develops a governance proposal that encourages production of high-quality evidence by incentivizing well-designed RCTs of stool and stoolderived microbial products. The proposal would require that FDA change its current enforcement approach, but it would not require any change in statutes or regulations.

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