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Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children’s Pediatric Innovation Research Forum

Including adolescents in adult clinical trials can play an important role in making innovative new medicines available to children in a timelier fashion. Stakeholders involved in the processes leading to regulatory approval and labeling of new drugs recognize that challenges exist in involving adole...

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Autores principales: Noel, Gary J., Nelson, Robert M., Bucci-Rechtweg, Christina, Portman, Ronald, Miller, Thomas, Green, Dionna J., Snyder, Donna, Moreno, Carmen, Hovinga, Collin, Connor, Edward
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8018511/
https://www.ncbi.nlm.nih.gov/pubmed/33811302
http://dx.doi.org/10.1007/s43441-021-00283-y
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author Noel, Gary J.
Nelson, Robert M.
Bucci-Rechtweg, Christina
Portman, Ronald
Miller, Thomas
Green, Dionna J.
Snyder, Donna
Moreno, Carmen
Hovinga, Collin
Connor, Edward
author_facet Noel, Gary J.
Nelson, Robert M.
Bucci-Rechtweg, Christina
Portman, Ronald
Miller, Thomas
Green, Dionna J.
Snyder, Donna
Moreno, Carmen
Hovinga, Collin
Connor, Edward
author_sort Noel, Gary J.
collection PubMed
description Including adolescents in adult clinical trials can play an important role in making innovative new medicines available to children in a timelier fashion. Stakeholders involved in the processes leading to regulatory approval and labeling of new drugs recognize that challenges exist in involving adolescents and older children in clinical trials before the safety and efficacy of these drugs are established for adults. However, it has been possible to design and execute phase 3 trials that combine adults with adolescents which are medically and scientifically sound and ethically justified. Based on this experience and considerations of the medical and scientific, ethical, and operation-related matters, the 2019 Pediatric Innovation Research Forum advocated for the position that adolescents routinely be considered for enrollment in phase 3 clinical trials. The Forum also concluded that exclusion of adolescents in adult pivotal trials occur only when a thorough evaluation of the target disease and the potential benefit and risks of the study intervention supports a delay in their involvement until after completion of clinical trials in adults.
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spelling pubmed-80185112021-04-06 Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children’s Pediatric Innovation Research Forum Noel, Gary J. Nelson, Robert M. Bucci-Rechtweg, Christina Portman, Ronald Miller, Thomas Green, Dionna J. Snyder, Donna Moreno, Carmen Hovinga, Collin Connor, Edward Ther Innov Regul Sci Analytical Report Including adolescents in adult clinical trials can play an important role in making innovative new medicines available to children in a timelier fashion. Stakeholders involved in the processes leading to regulatory approval and labeling of new drugs recognize that challenges exist in involving adolescents and older children in clinical trials before the safety and efficacy of these drugs are established for adults. However, it has been possible to design and execute phase 3 trials that combine adults with adolescents which are medically and scientifically sound and ethically justified. Based on this experience and considerations of the medical and scientific, ethical, and operation-related matters, the 2019 Pediatric Innovation Research Forum advocated for the position that adolescents routinely be considered for enrollment in phase 3 clinical trials. The Forum also concluded that exclusion of adolescents in adult pivotal trials occur only when a thorough evaluation of the target disease and the potential benefit and risks of the study intervention supports a delay in their involvement until after completion of clinical trials in adults. Springer International Publishing 2021-04-02 2021 /pmc/articles/PMC8018511/ /pubmed/33811302 http://dx.doi.org/10.1007/s43441-021-00283-y Text en © The Drug Information Association, Inc 2021 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Analytical Report
Noel, Gary J.
Nelson, Robert M.
Bucci-Rechtweg, Christina
Portman, Ronald
Miller, Thomas
Green, Dionna J.
Snyder, Donna
Moreno, Carmen
Hovinga, Collin
Connor, Edward
Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children’s Pediatric Innovation Research Forum
title Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children’s Pediatric Innovation Research Forum
title_full Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children’s Pediatric Innovation Research Forum
title_fullStr Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children’s Pediatric Innovation Research Forum
title_full_unstemmed Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children’s Pediatric Innovation Research Forum
title_short Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children’s Pediatric Innovation Research Forum
title_sort inclusion of adolescents in adult clinical trials: report of the institute for advanced clinical trials for children’s pediatric innovation research forum
topic Analytical Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8018511/
https://www.ncbi.nlm.nih.gov/pubmed/33811302
http://dx.doi.org/10.1007/s43441-021-00283-y
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