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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Hlavní autoři:	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
Médium:	Artigo
Jazyk:	Inglês
Vydáno:	Frontiers Media S.A. 2025-02-01
Edice:	Frontiers in Medicine
Témata:	pediatrics clinical trials regulatory science research ethics review research ethics committee institutional review board
On-line přístup:	https://www.frontiersin.org/articles/10.3389/fmed.2025.1539787/full
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