Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study

Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study

Abstract Background Early phase dose-finding (EPDF) trials are crucial for the development of a new intervention and influence whether it should be investigated in further trials. Guidance exists for clinical trial protocols and completed trial reports in the SPIRIT and CONSORT guidelines, respectiv...

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Main Authors: Olga Solovyeva, Munyaradzi Dimairo, Christopher J. Weir, Siew Wan Hee, Aude Espinasse, Moreno Ursino, Dhrusti Patel, Andrew Kightley, Sarah Hughes, Thomas Jaki, Adrian Mander, Thomas R. Jeffry Evans, Shing Lee, Sally Hopewell, Khadija Rerhou Rantell, An-Wen Chan, Alun Bedding, Richard Stephens, Dawn Richards, Lesley Roberts, John Kirkpatrick, Johann de Bono, Christina Yap
Format: Article
Language:English
Published: BMC 2023-07-01
Series:BMC Medicine
Subjects:
early phase
clinical trials
SPIRIT guideline
CONSORT guideline
dose finding
Online Access:https://doi.org/10.1186/s12916-023-02937-0

Internet

https://doi.org/10.1186/s12916-023-02937-0

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