Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance.

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BMJ CONSORT-DEFINE Statement_R1_AcceptedVersion.pdf (458.31 KB)

Embargo End Date

ICR Authors

Yap, Christina
 Solovyeva, Olga
 De Bono, Johann
 Rekowski, Jan
 Espinasse, Aude

Authors

Yap, C
Solovyeva, O
de Bono, J
Rekowski, J
Patel, D
Jaki, T
Mander, A
Evans, TRJ
Peck, R
Hayward, KS
Hopewell, S
Ursino, M
Rantell, KR
Calvert, M
Lee, S
Kightley, A
Ashby, D
Chan, A-W
Garrett-Mayer, E
Isaacs, JD
Golub, R
Kholmanskikh, O
Richards, D
Boix, O
Matcham, J
Seymour, L
Ivy, SP
Marshall, LV
Hommais, A
Liu, R
Tanaka, Y
Berlin, J
Espinasse, A
Dimairo, M
Weir, CJ

Document Type

Journal Article

Date

2023-10-20

Date Accepted

2023-08-07

Abstract

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.

Citation

BMJ: British Medical Journal,

DOI

URI

https://repository.icr.ac.uk/handle/internal/5962

Rights

http://creativecommons.org/licenses/by/4.0/

Source Title

BMJ: British Medical Journal

Publisher

BMJ PUBLISHING GROUP

ISSN

0959-535X

eISSN

Collections

Clinical Studies

Research Team

Clin Trials & Stats Unit

Notes