Espinasse, Aude and Solovyeva, Olga and Dimairo, Munyaradzi and Weir, Christopher and Jaki, Thomas and Mander, Adrian and Kightley, Andrew and Evans, Jeffry and Lee, Shing and Bedding, Alun and Hopewell, Sally and Rantell, Khadija and Liu, Rong and Chan, An-Wen and De Bono, Johann and Yap, Christina (2023) SPIRIT and CONSORT extensions for early phase dose-finding clinical trials: the DEFINE (DosE-FIndiNg Extensions) study protocol. BMJ OPEN, 13 (3): e068173. ISSN 2044-6055,
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Introduction Early phase dose-finding (EPDF) studies are critical for the development of new treatments, directly influencing whether compounds or interventions can be investigated in further trials to confirm their safety and efficacy. There exists guidance for clinical trial protocols and reporting of completed trials in the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and CONsolidated Standards Of Reporting Randomised Trials (CONSORT) 2010 statements. However, neither the original statements nor their extensions adequately cover the specific features of EPDF trials. The DEFINE (DosE-FIndiNg Extensions) study aims to enhance transparency, completeness, reproducibility and interpretation of EPDF trial protocols (SPIRIT-DEFINE) and their reports once completed (CONSORT-DEFINE), across all disease areas, building on the original SPIRIT 2013 and CONSORT 2010 statements. Methods and analysis A methodological review of published EPDF trials will be conducted to identify features and deficiencies in reporting and inform the initial generation of the candidate items. The early draft checklists will be enriched through a review of published and grey literature, real-world examples analysis, citation and reference searches and consultation with international experts, including regulators and journal editors. Development of CONSORT-DEFINE commenced in March 2021, followed by SPIRIT-DEFINE from January 2022. A modified Delphi process, involving worldwide, multidisciplinary and cross-sector key stakeholders, will be run to refine the checklists. An international consensus meeting in autumn 2022 will finalise the list of items to be included in both guidance extensions. Ethics and dissemination This project was approved by ICR's Committee for Clinical Research. The Health Research Authority confirmed Research Ethics Approval is not required. The dissemination strategy aims to maximise guideline awareness and uptake, including but not limited to dissemination in stakeholder meetings, conferences, peer-reviewed publications and on the EQUATOR Network and DEFINE study websites. Registration details SPIRIT-DEFINE and CONSORT-DEFINE are registered with the EQUATOR Network.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | STATISTICAL-METHODS; DESIGNS; AGREEMENT; EDUCATION & TRAINING (see Medical Education & Training); STATISTICS & RESEARCH METHODS; Protocols & guidelines |
| Subjects: | 000 Computer science, information & general works > 004 Computer science |
| Divisions: | Informatics and Data Science > Department Machine Learning & Data Science > Lehrstuhl für Computational Statistics (Prof. Dr. Thomas Jaki) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 09 Apr 2024 06:35 |
| Last Modified: | 09 Apr 2024 06:35 |
| URI: | https://pred.uni-regensburg.de/id/eprint/60699 |
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