Requirements and special considerations for drug trials with children across six jurisdictions: 1. Clinical trial application review in the regulatory approval process

Requirements and special considerations for drug trials with children across six jurisdictions: 1. Clinical trial application review in the regulatory approval process

BackgroundConducting clinical trials (CTs) with children presents several challenges. A major challenge is the need to enrol participants at multiple sites across different jurisdictions. Regardless of whether the trials involve children, adults, or both, CTs need to meet separate Competent Authorit...

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Main Authors: Breanne Stewart, Pirkko Lepola, Gunter F. Egger, Fahimeda Ali, Albert J. Allen, Alysha K. Croker, Andrew J. Davidson, Pamela Dicks, Saul N. Faust, Dionna Green, Collin Hovinga, Agnes V. Klein, Robyn Langham, Hidefumi Nakamura, Laura Pioppo, Shiva Ramroop, Michiyo Sakiyama, Isabel Sanchez Vigil de la Villa, Junko Sato, Donna L. Snyder, Mark A. Turner, Sarah Zaidi, Kanecia Zimmerman, Thierry Lacaze-Masmonteil
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-04-01
Series:Frontiers in Medicine
Subjects:
pediatrics
clinical trials
regulatory science
clinical trial application
clinical trial authorization
risk-based approach
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2025.1542408/full
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