Ashby, Deborah

Berlin, Jordan

Boix, Oliver

Calvert, Melanie

Chan, An-Wen

de Bono, Johann

Dimairo, Munyaradzi

Espinasse, Aude

Evans, Thomas R. Jeffry

Garrett Mayer , Elizabeth

Golub, Robert

Hayward, Kathryn S

Hommais, Antoine

Hopewell, Sally

Isaacs, John D

Ivy, S. Percy

Jaki, Thomas

Kholmanskikh, Olga

Kightley, Andrew

Lee, Shing

Liu, Rong

Marshall, Lynley V

Matcham, James

Patel, Dhrusti

Peck , Richard

Rantell, Khadija Rerhou

Rekowski , Jan

Richards, Dawn P.

Seymour, Lesley

Solovyeva, Olga

Tanaka, Yoshiya

Ursino, Moreno

Weir, Christopher J

Yap, Christina

English

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

University of Birmingham Research Portal

Enhancing Reporting Quality and Impact of Early Phase Dose-Finding Clinical Trials:The CONSORT Dose-Finding Extension (CONSORT-DEFINE) Guidance

http://pure-oai.bham.ac.uk/ws/files/202665789/BMJ_CONSORT_DEFINE_Statement_R1_clean.pdf

Enhancing Reporting Quality and Impact of Early Phase Dose-Finding Clinical Trials:The CONSORT Dose-Finding Extension (CONSORT-DEFINE) Guidance The CONSORT-DEFINE Statement

Enhancing Reporting Quality and Impact of Early Phase Dose-Finding Clinical Trials:The CONSORT Dose-Finding Extension (CONSORT-DEFINE) Guidance The CONSORT-DEFINE Statement

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University of Birmingham Research Portal