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- Title
A site assessment tool for inpatient controlled human infection models for enteric disease pathogens.
- Authors
Porter, Chad K; Detizio, Katherine J; Maier, Nicole; Testa, Kayla J; Talaat, Kawsar R; Chen, Wilbur H; Lyon, Caroline E; Gutierrez, Ramiro L; Frenck, Robert; Isidean, Sandra D; Kaminski, Robert W; Alcala, Ashley N; Hanevik, Kurt; Sawe, Frederick; Kirkpatrick, Beth D; Louis Bourgeois, A
- Abstract
The use of the controlled human infection model to facilitate product development and to advance understanding of host-pathogen interactions is of increasing interest. While administering a virulent (or infective) organism to a susceptible host necessitates an ongoing evaluation of safety and ethical considerations, a central theme in conducting these studies in a safe and ethical manner that yields actionable data is their conduct in facilities well-suited to address their unique attributes. To that end, we have developed a framework for evaluating potential sites in which to conduct inpatient enteric controlled human infection model to ensure consistency and increase the likelihood of success.
- Subjects
DIARRHEA prevention; BIOLOGICAL models; CLINICAL trials; HEALTH facilities; HUMAN research subjects; PREVENTION of communicable diseases; CONCEPTUAL structures; RESEARCH ethics
- Publication
Clinical Trials, 2022, Vol 19, Issue 1, p116
- ISSN
1740-7745
- Publication type
Article
- DOI
10.1177/17407745211052473