A site assessment tool for inpatient controlled human infection models for enteric disease pathogens.
Controlled human infection models
diarrheal disease
enteric infection
vaccine
Journal
Clinical trials (London, England)
ISSN: 1740-7753
Titre abrégé: Clin Trials
Pays: England
ID NLM: 101197451
Informations de publication
Date de publication:
02 2022
02 2022
Historique:
pubmed:
29
10
2021
medline:
4
5
2022
entrez:
28
10
2021
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 34708664
doi: 10.1177/17407745211052473
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM