Rekowski, J. orcid.org/0000-0002-5207-3864, Guo, C., Solovyeva, O. et al. (35 more authors) (2025) CONSORT-DEFINE explanation and elaboration: recommendations for enhancing reporting quality and impact of early phase dose-finding clinical trials. eClinicalMedicine, 79. 102987. ISSN 2589-5370
Abstract
Early phase dose-finding (EPDF) trials are key in the development of novel therapies, with their findings directly informing subsequent clinical development phases and providing valuable insights for reverse translation. Comprehensive and transparent reporting of these studies is critical for their accurate and critical interpretation, which may improve and expedite therapeutic development. However, quality of reporting of design characteristics and results from EPDF trials is often variable and incomplete. The international consensus-based CONSORT-DEFINE (Consolidated Standards for Reporting Trials Dose-finding Extension) statement, an extension of the CONSORT statement for randomised trials, was developed to improve the reporting of EPDF trials. The CONSORT-DEFINE statement introduced 21 new items and modified 19 existing CONSORT items. This CONSORT-DEFINE Explanation and Elaboration (E&E) document provides important information to enhance understanding and facilitate the implementation of the CONSORT-DEFINE checklist. For each new or modified checklist item, we provide a detailed description and its rationale with supporting evidence, and present examples from EPDF trial reports published in peer-reviewed scientific journals. When reporting the results of EPDF trials, authors are encouraged to consult the CONSORT-DEFINE E&E document, together with the CONSORT and CONSORT-DEFINE statement papers, and adhere to their recommendations. Widespread adoption of the CONSORT-DEFINE statement is likely to enhance the reporting quality of EPDF trials, thus facilitating the peer review of such studies and their appraisal by researchers, regulators, ethics committee members, and funders.
Metadata
Item Type: | Article |
---|---|
Authors/Creators: |
|
Copyright, Publisher and Additional Information: | © 2024 The Authors. Except as otherwise noted, this author-accepted version of a journal article published in eClinicalMedicine is made available via the University of Sheffield Research Publications and Copyright Policy under the terms of the Creative Commons Attribution 4.0 International License (CC-BY 4.0), which permits unrestricted use, distribution and reproduction in any medium, provided the original work is properly cited. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ © 2024 The Authors. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial Licence (https://creativecommons.org/licenses/by-nc/4.0/) |
Keywords: | Early phase trials; Phase I; Dose-finding; Dose escalation/de-escalation; Reporting guidance; CONSORT-DEFINE; CONSORT |
Dates: |
|
Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Medicine and Population Health |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 20 Jan 2025 11:55 |
Last Modified: | 03 Feb 2025 12:31 |
Status: | Published |
Publisher: | Elsevier BV |
Refereed: | Yes |
Identification Number: | 10.1016/j.eclinm.2024.102987 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:221690 |
Downloads
Filename: CONSORT-DEFINE E&E eclinm-D-24-02104.pdf
Licence: CC-BY 4.0
Filename: PIIS2589537024005662.pdf
Licence: CC-BY-NC 4.0
Filename: 1-s2.0-S2589537024005662-mmc1.pdf
Licence: CC-BY 4.0