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Development process of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE (DosE FIndiNg Extensions) study

2023-04-03

Abstract excerpt

<p>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, respectively. However, both guidelines and their extensions do not adequately address the characteristics of EPDF trials. Building o...

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Literature Corpus work: f7039214-a989-576f-84fc-8ffb2ced8c72
DOI: 10.31222/osf.io/jtpz2

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