Rekowski, Jan and Guo, Christina and Solovyeva, Olga and Dimairo, Munyaradzi and Rouhifard, Mahtab and Patel, Dhrusti and Alger, Emily and Ashby, Deborah and Berlin, Jordan and Boix, Oliver and Calvert, Melanie and Chan, An-Wen and Coschi, Courtney H. and de Bono, Johann and Evans, Thomas R. Jeffry and Garrett-Mayer, Elizabeth and Golub, Robert M. and Hayward, Kathryn S. and Hopewell, Sally and Isaacs, John D. and Ivy, S. Percy and Jaki, Thomas and Kholmanskikh, Olga and Kightley, Andrew and Lee, Shing and Liu, Rong and Maia, Israel and Mander, Adrian and Marshall, Lynley and Matcham, James and Peck, Richard and Rantell, Khadija Rerhou and Richards, Dawn P. and Seymour, Lesley and Tanaka, Yoshiya and Ursino, Moreno and Weir, Christopher J. and Yap, Christina (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
Full text not available from this repository. (Request a copy)Abstract
Early phase dose-finding (EPDF) trials are key in the development of novel therapies, with their fi ndings 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 (ICRCTSU) 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. Copyright (c) 2024 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC license (http://creativecommons.org/licenses/by-nc/4.0/).
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | ADVANCED SOLID TUMORS; OPEN-LABEL; MULTIPLE-MYELOMA; DOUBLE-BLIND; I TRIAL; RADIATION-THERAPY; RANDOMIZED-TRIALS; KINASE INHIBITOR; SAFETY; ESCALATION; Early phase trials; Phase I; Dose-finding; Dose escalation/de-escalation; Reporting guidance; CONSORT- DEFINE; CONSORT |
| Subjects: | 000 Computer science, information & general works > 004 Computer science 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Informatics and Data Science > Department Machine Learning & Data Science > Lehrstuhl für Computational Statistics (Prof. Dr. Thomas Jaki) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 24 Mar 2026 07:47 |
| Last Modified: | 24 Mar 2026 07:47 |
| URI: | https://pred.uni-regensburg.de/id/eprint/68073 |
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