How many minors are participating in clinical research today? An estimate and important lessons learned

Autor: Richard F. Ittenbach, Jeremy J. Corsmo, Alison D. Kissling, Arnold W. Strauss
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Journal of Clinical and Translational Science, Vol 5 (2021)
Druh dokumentu: article
ISSN: 2059-8661
DOI: 10.1017/cts.2021.844
Popis: Little is known about the number of minors enrolled in clinical research today. IRB administrators at leading pediatric medical centers were surveyed regarding studies with minors. Analyses were descriptive in nature with adaptive Bayesian bootstrap imputation used with missing data. Officials from 17/41 (41.5%) pediatric research centers responded: 74,204 active studies were estimated, 29,078 (39%) included minors, and 6574 (23%) were “more than minimal risk.” Minors accounted for 0.7–2.87M research subjects. Pediatric medicine desperately needs a more accurate and reliable reporting system for tracking the recruitment, retention, and involvement of minors in clinical research.
Databáze: Directory of Open Access Journals