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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).
© 2024 The Author(s). 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. Funding: This work is a further extension of the CONSORT-DEFINE study, which was funded by the UK Medical Research Council (MRC)- National Institute for Health and Care Research (NIHR) Methodology Research Programme (MR/T044934/1). The Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU) receives programmatic infrastructure funding from Cancer Research UK (C1491/A25351; CTUQQR-Dec 22/100 004), which has contributed to accelerating the advancement and successful completion of this work.
Author(s): Rekowski J, Guo C, Solovyeva O, Dimairo M, Rouhifard M, Patel D, Alger E, Ashby D, Berlin J, Boix O, Calvert M, Chan A-W, Coschi CH, de Bono J, Evans TRJ, Garrett-Mayer E, Golub RM, Hayward KS, Hopewell S, Isaacs JD, Ivy SP, Jaki T, Kholmanskikh O, Kightley A, Lee S, Liu R, Maia I, Mander A, Marshall LV, Matcham J, Peck R, Rantell KR, Richards DP, Seymour L, Tanaka Y, Ursino M, Weir CJ, Yap C
Publication type: Article
Publication status: Published
Journal: eClinicalMedicine
Year: 2025
Volume: 79
Online publication date: 10/01/2025
Acceptance date: 20/11/2024
Date deposited: 21/01/2025
ISSN (electronic): 2589-5370
Publisher: Elsevier Ltd
URL: https://doi.org/10.1016/j.eclinm.2024.102987
DOI: 10.1016/j.eclinm.2024.102987
Data Access Statement: This study compiled examples from previously published articles, each referenced individually in the manuscript. As this study did not generate new data, no additional dataset is provided. Permissions for re-using previously published material can be viewed upon reasonable request.
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