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

Autor:	Ittenbach RF; Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.; University of Cincinnati College of Medicine, Cincinnati, OH, USA., Corsmo JJ; Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.; University of Cincinnati College of Medicine, Cincinnati, OH, USA., Kissling AD; Edward L. Pratt Library, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA., Strauss AW; Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.; University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Jazyk:	angličtina
Zdroj:	Journal of clinical and translational science [J Clin Transl Sci] 2021 Sep 06; Vol. 5 (1), pp. e179. Date of Electronic Publication: 2021 Sep 06 (Print Publication: 2021).
DOI:	10.1017/cts.2021.844
Abstrakt:	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. Competing Interests: The authors have no conflicts of interest to declare. (© The Author(s) 2021.)
Databáze:	MEDLINE
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