Yap, Christina and Rekowski, Jan and Ursino, Moreno and Solovyeva, Olga and Patel, Dhrusti and Dimairo, Munyaradzi and Weir, Christopher J. and Chan, An-Wen and Jaki, Thomas and Mander, Adrian and Evans, Thomas R. Jeffry and Peck, Richard and Hayward, Kathryn S. and Calvert, Melanie and Rantell, Khadija Rerhou and Lee, Shing and Kightley, Andrew and Hopewell, Sally and Ashby, Deborah and Garrett-Mayer, Elizabeth and Isaacs, John and Golub, Robert and Kholmanskikh, Olga and Richards, Dawn P. 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 de Bono, Johann (2023) Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance. BMJ-BRITISH MEDICAL JOURNAL, 383: e076386. ISSN 0959-535X, 1756-1833
Full text not available from this repository. (Request a copy)Abstract
SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 provides guidance for clinical trial protocol writing. However, neither the original guidance nor its extensions adequately cover the features of early phase dose-finding trials. The SPIRIT Dose-finding Extension (DEFINE) statement is a new guideline that provides recommendations for essential items that should be provided in the protocols of these trials. It details extensions to the SPIRIT 2013 guidance, incorporating 17 new items and modifying 15 existing items. The purpose of this guideline is to promote transparency, completeness, reproducibility of methods, and interpretation of early phase dose finding trial protocols. It is envisioned that the resulting improvements in the design and conduct of early phase clinical trials will ultimately reduce research inefficiencies and inconsistencies, driving transformational advances in clinical care.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | PATIENT-REPORTED OUTCOMES; ESCALATION METHODS; INTERVAL DESIGN; GUIDELINES; CONSENSUS; DELPHI; |
| 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 07:21 |
| Last Modified: | 30 Jan 2024 07:21 |
| URI: | https://pred.uni-regensburg.de/id/eprint/60970 |
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