SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocolsResearch in context

SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocolsResearch in context

Summary: Transparent and accurate reporting in early phase dose-finding (EPDF) clinical trials is crucial for informing subsequent larger trials. The SPIRIT statement, designed for trial protocol content, does not adequately cover the distinctive features of EPDF trials. Recent findings indicate tha...

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Main Authors: Moreno Ursino, Guillermo Villacampa, Jan Rekowski, Munyaradzi Dimairo, Olga Solovyeva, Deborah Ashby, Jordan Berlin, Oliver Boix, Melanie Calvert, An-Wen Chan, Courtney H. Coschi, Thomas R. Jeffry Evans, Elizabeth Garrett-Mayer, Robert M. Golub, Christina Guo, Kathryn S. Hayward, Sally Hopewell, John D. Isaacs, S. Percy Ivy, Thomas Jaki, Olga Kholmanskikh, Andrew Kightley, Shing Lee, Rong Liu, Adrian Mander, Lynley V. Marshall, James Matcham, Dhrusti Patel, Richard Peck, Khadija Rerhou Rantell, Dawn P. Richards, Mahtab Rouhifard, Lesley Seymour, Yoshiya Tanaka, Christopher J. Weir, Johann de Bono, 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
Protocol guidance
SPIRIT-DEFINE
Online Access:http://www.sciencedirect.com/science/article/pii/S2589537024005674
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