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

Olga Solovyeva1, Munyaradzi Dimairo2, Christopher J Weir3

  • 1The Institute of Cancer Research, London, UK.

BMC Medicine
|July 5, 2023
PubMed
Summary

New guidelines, SPIRIT-DEFINE and CONSORT-DEFINE, were developed for early phase dose-finding (EPDF) trials. These guidelines aim to improve the transparency and reproducibility of EPDF trial protocols and reports.

Keywords:
CONSORT guidelineSPIRIT guidelineclinical trialsdose findingearly phase

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