CONSORT-DEFINE explanation and elaboration: recommendations for enhancing reporting quality and impact of early phase dose-finding clinical trialsResearch in context

Summary: Early phase dose-finding (EPDF) trials are key in the development of novel therapies, with their findings directly informing subsequent clinical development phases and providing valuable insights for reverse translation. Comprehensive and transparent reporting of these studies is critical f...

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Autors principals:	Jan Rekowski, Christina Guo, Olga Solovyeva, Munyaradzi Dimairo, Mahtab Rouhifard, Dhrusti Patel, Emily Alger, Deborah Ashby, Jordan Berlin, Oliver Boix, Melanie Calvert, An-Wen Chan, Courtney H. Coschi, Johann de Bono, Thomas R. Jeffry Evans, Elizabeth Garrett–Mayer, Robert M. Golub, Kathryn S. Hayward, Sally Hopewell, John D. Isaacs, S. Percy Ivy, Thomas Jaki, Olga Kholmanskikh, Andrew Kightley, Shing Lee, Rong Liu, Israel Maia, Adrian Mander, Lynley V. Marshall, James Matcham, Richard Peck, Khadija Rerhou Rantell, Dawn P. Richards, Lesley Seymour, Yoshiya Tanaka, Moreno Ursino, Christopher J. Weir, Christina Yap
Format:	Artigo
Idioma:	Inglês
Publicat:	Elsevier 2025-01-01
Col·lecció:	EClinicalMedicine
Matèries:	Early phase trials Phase I Dose-finding Dose escalation/de-escalation Reporting guidance CONSORT-DEFINE
Accés en línia:	http://www.sciencedirect.com/science/article/pii/S2589537024005662
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