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

URN to cite this document:: urn:nbn:de:bvb:355-epub-777659
DOI to cite this document:: 10.5283/epub.77765

Ursino, Moreno ; Villacampa, Guillermo ; Rekowski, Jan ; Dimairo, Munyaradzi ; Solovyeva, Olga ; Ashby, Deborah ; Berlin, Jordan ; Boix, Oliver ; Calvert, Melanie ; Chan, An-Wen ; Coschi, Courtney H. ; Evans, Thomas R. Jeffry ; Garrett-Mayer, Elizabeth ; Golub, Robert M. ; Guo, Christina ; Hayward, Kathryn S. ; Hopewell, Sally ; Isaacs, John D. ; Ivy, S. Percy ; Jaki, Thomas

; Kholmanskikh, Olga ; Kightley, Andrew ; Lee, Shing ; Liu, Rong ; Mander, Adrian ; Marshall, Lynley V. ; Matcham, James ; Patel, Dhrusti ; Peck, Richard ; Rantell, Khadija Rerhou ; Richards, Dawn P. ; Rouhifard, Mahtab ; Seymour, Lesley ; Tanaka, Yoshiya ; Weir, Christopher J. ; de Bono, Johann ; Yap, Christina

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Date of publication of this fulltext: 18 Sep 2025 05:15

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Abstract

Transparent and accurate reporting in early phase dose-finding (EPDF) clinical trials is crucial for informing subsequent larger trials. The SPIRIT statement, designed for trial protocol content, does not adequately cover the distinctive features of EPDF trials. Recent findings indicate that the protocol contents in past EPDF trials frequently lacked completeness and clarity. To address this gap, ...