| Title: |
Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study |
| Authors: |
Solovyeva, Olga; Dimairo, Munyaradzi; Weir, Christopher; Hee, Siew Wan; Espinasse, Aude; Ursino, Moreno; Patel, Dhrusti; Kightley, Andrew; Hughes, Sarah; Jaki, Thomas; Mander, Adrian; Evans, Thomas; Lee, Shing; Hopewell, Sally; Rantell, Khadija Rerhou; Chan, An-Wen; Bedding, Alun; Stephens, Richard; Richards, Dawn; Roberts, Lesley; Kirkpatrick, John; de Bono, Johann; Yap, Christina |
| Contributors: |
The Institute of Cancer Research; School of Health and Related Research; University of Sheffield Sheffield; Usher Institute of Population Health Sciences and Informatics Edinburgh, U.K.; The University of Edinburgh; University of Warwick Coventry; Centre de Recherche des Cordeliers (CRC (UMR_S_1138 / U1138)); École Pratique des Hautes Études (EPHE); Université Paris Sciences et Lettres (PSL)-Université Paris Sciences et Lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Paris Cité (UPCité); Health data- and model- driven Knowledge Acquisition (HeKA); Centre Inria de Paris; Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Centre de Recherche des Cordeliers (CRC (UMR_S_1138 / U1138)); Université Paris Sciences et Lettres (PSL)-Université Paris Sciences et Lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Paris Cité (UPCité)-École Pratique des Hautes Études (EPHE); Patient and public involvement and engagement lead Lichfield (PPIE); University of Oxford; University of Cambridge Cambridge, UK (CAM); Universität Regensburg = University of Regensburg = Université de Ratisbonne Allemagne (UR); GlaxoSmithKline (GSK); University of Glasgow; Columbia University New York; Medicines and Healthcare Products Regulatory Agency (MHRA); University of Toronto; Roche Products Ltd; National Cancer Research Institute London (NCRI); Clinical Trials Ontario; The CONSORT-DEFINE part of this study was supported by the UKRI’s MRC-NIHR grant number MR/T044934/1. The SPIRIT-DEFINE part received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. T Jaki received funding from the UK Medical Research Council (MC_UU_00002/14). Christopher J Weir was supported in this work by NHS Lothian via EdinburghClinical Trials Unit. Shing Lee was funded through the National Center for Advancing Translational Sciences, National Institutes of Health (Grant Number UL1TR001873) |
| Source: |
ISSN: 1741-7015. |
| Publisher Information: |
CCSD; BioMed Central |
| Publication Year: |
2023 |
| Subject Terms: |
[SHS]Humanities and Social Sciences |
| Description: |
International audience ; Abstract Background Early phase dose-finding (EPDF) trials are crucial for the development of a new intervention and influence whether it should be investigated in further trials. Guidance exists for clinical trial protocols and completed trial reports in the SPIRIT and CONSORT guidelines, respectively. However, both guidelines and their extensions do not adequately address the characteristics of EPDF trials. Building on the SPIRIT and CONSORT checklists, the DEFINE study aims to develop international consensus-driven guidelines for EPDF trial protocols (SPIRIT-DEFINE) and reports (CONSORT-DEFINE). Methods The initial generation of candidate items was informed by reviewing published EPDF trial reports. The early draft items were refined further through a review of the published and grey literature, analysis of real-world examples, citation and reference searches, and expert recommendations, followed by a two-round modified Delphi process. Patient and public involvement and engagement (PPIE) was pursued concurrently with the quantitative and thematic analysis of Delphi participants’ feedback. Results The Delphi survey included 79 new or modified SPIRIT-DEFINE ( n = 36) and CONSORT-DEFINE ( n = 43) extension candidate items. In Round One, 206 interdisciplinary stakeholders from 24 countries voted and 151 stakeholders voted in Round Two. Following Round One feedback, one item for CONSORT-DEFINE was added in Round Two. Of the 80 items, 60 met the threshold for inclusion (≥ 70% of respondents voted critical: 26 SPIRIT-DEFINE, 34 CONSORT-DEFINE), with the remaining 20 items to be further discussed at the consensus meeting. The parallel PPIE work resulted in the development of an EPDF lay summary toolkit consisting of a template with guidance notes and an exemplar. Conclusions By detailing the development journey of the DEFINE study and the decisions undertaken, we envision that this will enhance understanding and help researchers in the development of future guidelines. The SPIRIT-DEFINE and ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1186/s12916-023-02937-0 |
| Availability: |
https://hal.science/hal-04336816; https://hal.science/hal-04336816v1/document; https://hal.science/hal-04336816v1/file/s12916-023-02937-0.pdf; https://doi.org/10.1186/s12916-023-02937-0 |
| Rights: |
https://creativecommons.org/licenses/by/4.0/ ; info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.44CD5BEA |
| Database: |
BASE |