Academic Journal
SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocolsResearch in context
| العنوان: | SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocolsResearch in context |
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| المؤلفون: | Moreno Ursino, Guillermo Villacampa, Jan Rekowski, Munyaradzi Dimairo, Olga Solovyeva, Deborah Ashby, Jordan Berlin, Oliver Boix, Melanie Calvert, An-Wen Chan, Courtney H. Coschi, Thomas R. Jeffry Evans, Elizabeth Garrett-Mayer, Robert M. Golub, Christina Guo, Kathryn S. Hayward, Sally Hopewell, John D. Isaacs, S. Percy Ivy, Thomas Jaki, Olga Kholmanskikh, Andrew Kightley, Shing Lee, Rong Liu, Adrian Mander, Lynley V. Marshall, James Matcham, Dhrusti Patel, Richard Peck, Khadija Rerhou Rantell, Dawn P. Richards, Mahtab Rouhifard, Lesley Seymour, Yoshiya Tanaka, Christopher J. Weir, Johann de Bono, Christina Yap |
| المصدر: | EClinicalMedicine, Vol 79, Iss , Pp 102988- (2025) |
| بيانات النشر: | Elsevier |
| سنة النشر: | 2025 |
| المجموعة: | Directory of Open Access Journals: DOAJ Articles |
| مصطلحات موضوعية: | Early phase trials, Phase I, Dose-finding, Dose escalation/de-escalation, Protocol guidance, SPIRIT-DEFINE, Medicine (General), R5-920 |
| الوصف: | Summary: Transparent and accurate reporting in early phase dose-finding (EPDF) clinical trials is crucial for informing subsequent larger trials. The SPIRIT statement, designed for trial protocol content, does not adequately cover the distinctive features of EPDF trials. Recent findings indicate that the protocol contents in past EPDF trials frequently lacked completeness and clarity. To address this gap, the international consensus-driven SPIRIT-DEFINE checklist was developed through a robust methodological framework for guideline development, with the aim to improve completeness and clarity in EPDF trial protocols. The checklist builds on the SPIRIT statement, adding 17 new items and modifying 15 existing ones.The SPIRIT-DEFINE explanation and elaboration (E&E) document provides comprehensive information to enhance understanding and usability of the SPIRIT-DEFINE checklist when writing an EPDF trial protocol. Each new or modified checklist item is accompanied by a detailed description, its rationale with supportive evidence, and examples of good reporting curated from EPDF trial protocols covering a range of therapeutic areas and interventions. We recommend utilising this paper alongside the SPIRIT statement, and any relevant extensions, to enhance the development and review of EPDF trial protocols.By facilitating adoption of the SPIRIT-DEFINE statement for EPDF trials, this E&E document can promote enhancement of methodological rigour, patient safety, transparency, and facilitate the generation of high-quality, reproducible evidence that will strengthen the foundation of early phase research and ultimately improve patient outcomes. Funding: This work is a further extension of the SPIRIT-DEFINE study, which 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 ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| Relation: | http://www.sciencedirect.com/science/article/pii/S2589537024005674; https://doaj.org/toc/2589-5370; https://doaj.org/article/16dd34d979024228b814394d19daa037 |
| DOI: | 10.1016/j.eclinm.2024.102988 |
| الاتاحة: | https://doi.org/10.1016/j.eclinm.2024.102988 https://doaj.org/article/16dd34d979024228b814394d19daa037 |
| رقم الانضمام: | edsbas.C6C702C |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.eclinm.2024.102988 |
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