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, respectively. However, both guidelines and their extensions do not adequately address the characteristics of EPDF trials. Building on the SPIRIT and CONSORT checklists, the DEFINE study aims to develop international consensus-driven guidelines for EPDF trial protocols (SPIRIT-DEFINE) and reports (CONSORT-DEFINE).

Methods

The initial generation of candidate items was informed by reviewing published EPDF trial reports. The early draft items were refined further through a review of the published and g

SUBMITTER: Solovyeva O 

PROVIDER: S-EPMC10324137 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature