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

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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Main Authors: 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: Article
Language:English
Published: Elsevier 2025-01-01
Series:EClinicalMedicine
Subjects:
Early phase trials
Phase I
Dose-finding
Dose escalation/de-escalation
Reporting guidance
CONSORT-DEFINE
Online Access:http://www.sciencedirect.com/science/article/pii/S2589537024005662
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