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SPIRIT and CONSORT extensions for early phase dose-finding clinical trials: the DEFINE (DosE-FIndiNg Extensions)
Aude Espinasse1, Olga Solovyeva1, Munyaradzi Dimairo2
1Clinical Trial and Statistical Unit, Institute of Cancer Research Sutton, London, UK.
BMJ Open
|March 29, 2023
Summary
New guidelines, SPIRIT-DEFINE and CONSORT-DEFINE, will improve early phase dose-finding (EPDF) trial reporting. These extensions address current gaps to enhance transparency and reproducibility in clinical research.
Area of Science:
- Clinical Trials
- Pharmaceutical Development
- Medical Research Methodology
Background:
- Early phase dose-finding (EPDF) studies are crucial for advancing new treatments.
- Existing guidelines like SPIRIT 2013 and CONSORT 2010 do not fully address EPDF trial specifics.
- Gaps in EPDF trial reporting impact the progression of potential therapies.
Purpose of the Study:
- To enhance transparency, completeness, reproducibility, and interpretation of EPDF trial protocols and reports.
- To develop extensions to SPIRIT and CONSORT guidelines tailored for EPDF studies.
- To build upon existing SPIRIT 2013 and CONSORT 2010 frameworks.
Main Methods:
- Methodological review of published EPDF trials to identify reporting deficiencies.
- Enrichment of draft checklists through literature review, real-world data analysis, and expert consultation.
- Modified Delphi process and international consensus meeting to finalize guidance items.
Main Results:
- Development of SPIRIT-DEFINE and CONSORT-DEFINE is underway, with registration on the EQUATOR Network.
- Candidate items for the new guidelines are being generated and refined.
- International expert and stakeholder engagement is integral to the development process.
Conclusions:
- SPIRIT-DEFINE and CONSORT-DEFINE aim to significantly improve the quality of EPDF trial documentation.
- These extensions will support more robust evaluation and progression of novel therapeutic interventions.
- Enhanced reporting will ultimately benefit patient safety and treatment efficacy.
Keywords:
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