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

URN to cite this document:: urn:nbn:de:bvb:355-epub-762987
DOI to cite this document:: 10.5283/epub.76298

Yap, Christina

; Solovyeva, Olga

; de Bono, Johann

; Rekowski, Jan

; Patel, Dhrusti

; Jaki, Thomas

; Mander, Adrian

; Evans, Thomas R Jeffry ; Peck, Richard ; Hayward, Kathryn S

; Hopewell, Sally ; Ursino, Moreno ; Rantell, Khadija Rerhou ; Calvert, Melanie ; Lee, Shing ; Kightley, Andrew ; Ashby, Deborah ; Chan, An-Wen ; Garrett-Mayer, Elizabeth ; Isaacs, John D ; Golub, Robert ; Kholmanskikh, Olga ; Richards, Dawn ; Boix, Oliver ; Matcham, James ; Seymour, Lesley ; Ivy, S Percy ; Marshall, Lynley V ; Hommais, Antoine ; Liu, Rong ; Tanaka, Yoshiya ; Berlin, Jordan ; Espinasse, Aude ; Dimairo, Munyaradzi

; Weir, Christopher J

License: Creative Commons Attribution 4.0
PDF - Published Version
(410kB)

Date of publication of this fulltext: 18 Mar 2025 10:11

Alternative links to fulltext:DOI Publisher

Details

Preview

Indexed in

Export bibliographical data

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, ...