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

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 incent...

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Bibliographic Details
Published inThe Journal of law, medicine & ethics Vol. 47; no. 4; pp. 505 - 523
Main Authors Ossorio, Pilar N., Zhou, Yao
Format Journal Article
LanguageEnglish
Published Los Angeles, CA SAGE Publications 01.12.2019
Cambridge University Press
Subjects
Alzheimer's disease
Clinical trials
Data quality
Enforcement
Governance
Health technology assessment
Intervention
Microbiota
Quality of care
R&D
Research & development
Researchers
Statutes
Transplants & implants
United States > US
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Summary: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.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
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ISSN:1073-1105
1748-720X
DOI:10.1177/1073110519897727