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

URN zum Zitieren dieses Dokuments:
urn:nbn:de:bvb:355-epub-777659
DOI zum Zitieren dieses Dokuments:
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
Veröffentlichungsdatum dieses Volltextes: 18 Sep 2025 05:15



Zusammenfassung

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, ...

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