TY - JOUR
T1 - Enhancing Reporting Quality and Impact of Early Phase Dose-Finding Clinical Trials
T2 - The CONSORT Dose-Finding Extension (CONSORT-DEFINE) Guidance
AU - Yap, Christina
AU - Solovyeva, Olga
AU - de Bono, Johann
AU - Rekowski , Jan
AU - Patel, Dhrusti
AU - Jaki, Thomas
AU - Evans, Thomas R. Jeffry
AU - Peck , Richard
AU - Hayward, Kathryn S
AU - Hopewell, Sally
AU - Ursino, Moreno
AU - Rantell, Khadija Rerhou
AU - Calvert, Melanie
AU - Lee, Shing
AU - Kightley, Andrew
AU - Ashby, Deborah
AU - Chan, An-Wen
AU - Garrett Mayer , Elizabeth
AU - Isaacs, John D
AU - Golub, Robert
AU - Kholmanskikh, Olga
AU - Richards, Dawn P.
AU - Boix, Oliver
AU - Matcham, James
AU - Seymour, Lesley
AU - Ivy, S. Percy
AU - Marshall, Lynley V
AU - Hommais, Antoine
AU - Liu, Rong
AU - Tanaka, Yoshiya
AU - Berlin, Jordan
AU - Espinasse, Aude
AU - Dimairo, Munyaradzi
AU - Weir, Christopher J
N1 - Funding: CONSORT-DEFINE is funded by the UK Medical Research Council (MRC)-National Institute for Health and Care Research (NIHR) Methodology Research Programme (grant MR/T044934/1). ICR-CTSU receives programmatic infrastructure funding from Cancer Research UK (C1491/A25351), which has contributed to accelerating the advancement and successful completion of this work. TJ received funding from the MRC (MC_UU_00002/14). DA acknowledges support from the NIHR Imperial Biomedical Research Centre. LVM is funded by the Oak Foundation via the Royal Marsden Cancer Charity and also acknowledges funding support from the UK’s Experimental Cancer Medicines Centre Paediatric Network grant and the NIHR Royal Marsden/Institute of Cancer Research (ICR) Biomedical Research Centre. The funders and sponsor had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; the preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. This article reflects personal the views of the authors, the Delphi participants, and the consensus meeting participants, and may not represent the views of the broader stakeholder groups, authors’ institutions, or other affiliations. The personal views may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties, or to any organisation with which the authors are affiliated.
PY - 2023/10/20
Y1 - 2023/10/20
N2 - The CONSORT (CONsolidated Standards Of Reporting Trials) 2010 statement is the standard guideline for reporting completed randomised trials. The CONSORT Dose-finding Extension (DEFINE) extends the guidance (with 21 new items and 19 modified items) to early phase dose-finding trials with interim dose escalation or de-escalation strategies. Such trials generally focus on safety, tolerability, activity, and recommending dosing and scheduling regimens for further clinical development. These trials are often inadequately reported, hampering their informativeness and making evidence informed decisions difficult. The CONSORT-DEFINE guidance aims to develop an international, consensus driven guideline for reporting early phase dose-finding trials to promote transparency, completeness, reproducibility, and facilitate the interpretation of the results. The CONSORT-DEFINE guidance provides recommendations for essential items that should be reported in early phase dose-finding trials to promote greater clarity, reproducibility, informativeness, and usefulness of results.
AB - The CONSORT (CONsolidated Standards Of Reporting Trials) 2010 statement is the standard guideline for reporting completed randomised trials. The CONSORT Dose-finding Extension (DEFINE) extends the guidance (with 21 new items and 19 modified items) to early phase dose-finding trials with interim dose escalation or de-escalation strategies. Such trials generally focus on safety, tolerability, activity, and recommending dosing and scheduling regimens for further clinical development. These trials are often inadequately reported, hampering their informativeness and making evidence informed decisions difficult. The CONSORT-DEFINE guidance aims to develop an international, consensus driven guideline for reporting early phase dose-finding trials to promote transparency, completeness, reproducibility, and facilitate the interpretation of the results. The CONSORT-DEFINE guidance provides recommendations for essential items that should be reported in early phase dose-finding trials to promote greater clarity, reproducibility, informativeness, and usefulness of results.
UR - https://www.bmj.com/
U2 - 10.1136/bmj-2023-076387
DO - 10.1136/bmj-2023-076387
M3 - Article
SN - 1756-1833
VL - 383
JO - BMJ
JF - BMJ
M1 - e076387
ER -