Cargando…

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

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Ittenbach, Richard F., Corsmo, Jeremy J., Kissling, Alison D., Strauss, Arnold W.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8596071/
https://www.ncbi.nlm.nih.gov/pubmed/34849254
http://dx.doi.org/10.1017/cts.2021.844
_version_ 1784600282627309568
author Ittenbach, Richard F.
Corsmo, Jeremy J.
Kissling, Alison D.
Strauss, Arnold W.
author_facet Ittenbach, Richard F.
Corsmo, Jeremy J.
Kissling, Alison D.
Strauss, Arnold W.
author_sort Ittenbach, Richard F.
collection PubMed
description 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.
format Online
Article
Text
id pubmed-8596071
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher Cambridge University Press
record_format MEDLINE/PubMed
spelling pubmed-85960712021-11-29 How many minors are participating in clinical research today? An estimate and important lessons learned Ittenbach, Richard F. Corsmo, Jeremy J. Kissling, Alison D. Strauss, Arnold W. J Clin Transl Sci Brief Report 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. Cambridge University Press 2021-09-06 /pmc/articles/PMC8596071/ /pubmed/34849254 http://dx.doi.org/10.1017/cts.2021.844 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Brief Report
Ittenbach, Richard F.
Corsmo, Jeremy J.
Kissling, Alison D.
Strauss, Arnold W.
How many minors are participating in clinical research today? An estimate and important lessons learned
title How many minors are participating in clinical research today? An estimate and important lessons learned
title_full How many minors are participating in clinical research today? An estimate and important lessons learned
title_fullStr How many minors are participating in clinical research today? An estimate and important lessons learned
title_full_unstemmed How many minors are participating in clinical research today? An estimate and important lessons learned
title_short How many minors are participating in clinical research today? An estimate and important lessons learned
title_sort how many minors are participating in clinical research today? an estimate and important lessons learned
topic Brief Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8596071/
https://www.ncbi.nlm.nih.gov/pubmed/34849254
http://dx.doi.org/10.1017/cts.2021.844
work_keys_str_mv AT ittenbachrichardf howmanyminorsareparticipatinginclinicalresearchtodayanestimateandimportantlessonslearned
AT corsmojeremyj howmanyminorsareparticipatinginclinicalresearchtodayanestimateandimportantlessonslearned
AT kisslingalisond howmanyminorsareparticipatinginclinicalresearchtodayanestimateandimportantlessonslearned
AT straussarnoldw howmanyminorsareparticipatinginclinicalresearchtodayanestimateandimportantlessonslearned