dc.contributor
Institut Català de la Salut
dc.contributor
[Ursino M] ReCAP/F CRIN, INSERM, Nancy, France. Unit of Clinical Epidemiology, University Hospital Centre Robert Debré, Université Paris Cité, Paris, France. INSERM, Centre de Recherche des Cordeliers, Sorbonne Université, Université Paris Cité, Paris, France. HeKA Team, Centre Inria, Paris, France. [Villacampa G] Clinical Trials and Statistics Unit at The Institute of Cancer Research, London, UK. Statistics Unit, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. SOLTI Breast Cancer Research Group, Barcelona, Spain. [Rekowski J, Solovyeva O] Clinical Trials and Statistics Unit at The Institute of Cancer Research, London, UK. [Dimairo M] Division of Population Health, Sheffield Centre for Health and Related Research, University of Sheffield, Sheffield, UK. [Ashby D] School of Public Health, Imperial College London, St Mary's Hospital, London, UK
dc.contributor
Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
Ursino, Moreno
dc.contributor.author
Dimairo, Munyaradzi
dc.contributor.author
Solovyeva, Olga
dc.contributor.author
Ashby, Deborah
dc.contributor.author
Villacampa Javierre, Guillermo
dc.contributor.author
Rekowski, Jan
dc.date.accessioned
2025-10-25T05:38:12Z
dc.date.available
2025-10-25T05:38:12Z
dc.date.issued
2025-03-17T10:54:00Z
dc.date.issued
2025-03-17T10:54:00Z
dc.identifier
Ursino M, Villacampa G, Rekowski J, Dimairo M, Solovyeva O, Ashby D, et al. SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocols. eClinicalMedicine. 2025 Jan;79:102988.
dc.identifier
http://hdl.handle.net/11351/12771
dc.identifier
10.1016/j.eclinm.2024.102988
dc.identifier
001399829000001
dc.identifier.uri
http://hdl.handle.net/11351/12771
dc.description.abstract
Dose escalation/de-escalation; Dose-finding; Early phase trials
dc.description.abstract
Escalada/desescalada de dosis; Búsqueda de dosis; Ensayos de fase temprana
dc.description.abstract
Escalada/desescalada de la dosi; Cerca de dosis; Assaigs de fase inicial
dc.description.abstract
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.
dc.format
application/pdf
dc.relation
eClinicalMedicine;79
dc.relation
https://doi.org/10.1016/j.eclinm.2024.102988
dc.rights
Attribution-NonCommercial 4.0 International
dc.rights
http://creativecommons.org/licenses/by-nc/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Medicaments - Assaigs clínics
dc.subject
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics::Clinical Studies as Topic::Clinical Trials as Topic::Clinical Trials, Phase I as Topic
dc.subject
PHENOMENA AND PROCESSES::Physiological Phenomena::Pharmacological and Toxicological Phenomena::Pharmacological Phenomena::Dose-Response Relationship, Drug
dc.subject
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::métodos epidemiológicos::características de los estudios epidemiológicos::estudios clínicos como asunto::ensayos clínicos como asunto::ensayos clínicos en fase I como asunto
dc.subject
FENÓMENOS Y PROCESOS::fenómenos fisiológicos::fenómenos farmacológicos y toxicológicos::fenómenos farmacológicos::relación dosis-respuesta de medicamentos
dc.title
SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocols
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion
