Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process

Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process

BackgroundConducting clinical drug trials (CTs) with children presents several challenges. A major challenge is the need to enroll participants at multiple sites across different jurisdictions. Recruiting the required number of children within a reasonable timeframe requires the study to be reviewed...

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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. 2025-02-01
Series:Frontiers in Medicine
Subjects:
pediatrics
clinical trials
regulatory science
research ethics review
research ethics committee
institutional review board
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2025.1539787/full
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