Yap, Christina and Solovyeva, Olga and de Bono, Johann and Rekowski, Jan and Patel, Dhrusti and Jaki, Thomas and Mander, Adrian and Evans, Thomas R. Jeffry and Peck, Richard and Hayward, Kathryn S. and Hopewell, Sally and Ursino, Moreno and Rantell, Khadija Rerhou and Calvert, Melanie and Lee, Shing and Kightley, Andrew and Ashby, Deborah and Chan, An-Wen and Garrett-Mayer, Elizabeth and Isaacs, John and Golub, Robert and Kholmanskikh, Olga and Richards, Dawn and Boix, Oliver and Matcham, James and Seymour, Lesley and Ivy, S. Percy and Marshall, Lynley and Hommais, Antoine and Liu, Rong and Tanaka, Yoshiya and Berlin, Jordan and Espinasse, Aude and Dimairo, Munyaradzi and Weir, Christopher J. (2023) Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance. BMJ-BRITISH MEDICAL JOURNAL, 383: e076387. ISSN 0959-535X, 1756-1833
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | ESCALATION METHODS; RANDOMIZED-TRIALS; ADAPTIVE DESIGNS; INTERVAL DESIGN; CONSENSUS; GUIDELINES; STATEMENT; PROTOCOL; OUTCOMES; UPDATE; |
| Subjects: | 000 Computer science, information & general works > 004 Computer science |
| Divisions: | Informatics and Data Science |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 30 Jan 2024 07:19 |
| Last Modified: | 30 Jan 2024 07:19 |
| URI: | https://pred.uni-regensburg.de/id/eprint/60969 |
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