SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocols

Ursino, M., Villacampa, G., Rekowski, J. orcid.org/0000-0002-5207-3864 et al. (34 more authors) (2025) SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocols. eClinicalMedicine, 79. 102988. ISSN 2589-5370

Abstract

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Item Type: Article
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Copyright, Publisher and Additional Information:

© 2024 The Authors. Except as otherwise noted, this author-accepted version of a journal article published in eClinicalMedicine is made available via the University of Sheffield Research Publications and Copyright Policy under the terms of the Creative Commons Attribution 4.0 International License (CC-BY 4.0), which permits unrestricted use, distribution and reproduction in any medium, provided the original work is properly cited. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/

© 2024 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY-NC license (http://creativecommons.org/licenses/by-nc/4.0/).

Keywords: Early phase trials; Phase I; Dose-finding; Dose escalation/de-escalation; Protocol guidance; SPIRIT-DEFINE; SPIRIT
Dates:
  • Published: January 2025
  • Published (online): 10 January 2025
  • Accepted: 20 November 2024
  • Submitted: 25 June 2024
Institution: The University of Sheffield
Academic Units: The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Medicine and Population Health
Depositing User: Symplectic Sheffield
Date Deposited: 17 Jan 2025 16:42
Last Modified: 03 Feb 2025 12:38
Status: Published
Publisher: Elsevier BV
Refereed: Yes
Identification Number: 10.1016/j.eclinm.2024.102988
Open Archives Initiative ID (OAI ID):

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