Abstract
SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 provides guidance for clinical trial protocol writing. However, neither the original guidance nor its extensions adequately cover the features of early phase dose-finding trials. The SPIRIT Dose-finding Extension (DEFINE) statement is a new guideline that provides recommendations for essential items that should be provided in the protocols of these trials. It details extensions to the SPIRIT 2013 guidance, incorporating 17 new items and modifying 15 existing items. The purpose of this guideline is to promote transparency, completeness, reproducibility of methods, and interpretation of early phase dose-finding trial protocols. It is envisioned that the resulting improvements in the design and conduct of early phase clinical trials will ultimately reduce research inefficiencies and inconsistencies, driving transformational advances in clinical care.
| Original language | English (US) |
|---|---|
| Article number | bmj-2023-076386 |
| Journal | BMJ |
| DOIs | |
| State | Accepted/In press - 2023 |
Funding
Funding: The SPIRIT-DEFINE study obtained no external funding. The principal investigator (CY) used internal staff resources, together with additional resources from external partners, to conduct this study. The SPIRIT-DEFINE study is a component of the DEFINE project, which also developed the MRC/NIHR funded CONSORT-DEFINE guidance. ICR-CTSU receives programmatic infrastructure funding from Cancer Research UK (C1491/A25351), which has contributed to accelerating the advancement and successful completion of this work. TJ received funding from the UK Medical Research Council (MC_UU_00002/14). DA acknowledges support from the National Institute for Health and Care Research (NIHR) Imperial Biomedical Research Centre. KSH received funding from the National Health and Medical Research Council of Australia (grants 2016420, 2015705) and acknowledges support from the Heart Foundation of Australia (grant 106607). LVM is funded by the Oak Foundation via the Royal Marsden Cancer Charity and acknowledges further funding support from the UK’s Experimental Cancer Medicines Centre Paediatric Network grant and the NIHR Royal Marsden/Institute of Cancer Biomedical Research Centre. JdB received programmatic funding support from Cancer Research UK and the UK NIHR, who together support the Experimental Cancer Medicine Centre at the Royal Marsden and ICR, as well as from the Medical Research Council. The funders and sponsor had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; the preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. This article reflects the views of the authors, the Delphi participants, and the Consensus Meeting participants, and may not represent the views of the broader stakeholder groups, the authors' institutions, or other affiliations.
ASJC Scopus subject areas
- General Medicine