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., Dimairo, M., Solovyeva, O., Ashby, D., Berlin, J., Boix, O., Calvert, M., Chan, A.-W., Coschi, C. H., Evans, T. R. J., Garrett-Mayer, E., Golub, R. M., Guo, C., Hayward, K. S., Hopewell, S., Isaacs, J. D., Ivy, S. P., … Yap, C. (2025). SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocols. EClinicalMedicine, 79, 102988. https://doi.org/10.1016/j.eclinm.2024.102988
Authors:
Moreno Ursino
Guillermo Villacampa
Jan Rekowski
Munyaradzi Dimairo
Olga Solovyeva
Deborah Ashby
Jordan Berlin
Oliver Boix
Melanie Calvert
An-Wen Chan
Courtney H Coschi
Thomas R Jeffry Evans
Elizabeth Garrett-Mayer
Robert M Golub
Christina Guo
Kathryn S Hayward
Sally Hopewell
John D Isaacs
S Percy Ivy
Thomas Jaki
Olga Kholmanskikh
Andrew Kightley
Shing Lee
Rong Liu
Adrian Mander
Lynley V Marshall
James Matcham
Dhrusti Patel
Richard Peck
Khadija Rerhou Rantell
Dawn P Richards
Mahtab Rouhifard
Lesley Seymour
Yoshiya Tanaka
Christopher J Weir
Johann de Bono
Christina Yap
Affiliated Authors:
Shing Lee
Columbia Affiliation:
Author Keywords:
early phase trials
phase i
dose-finding
dose escalation/de-escalation
protocol guidance
spirit-define
spirit
elink
Publication Type:
Article
Unique ID:
10.1016/j.eclinm.2024.102988
PMID:
39877554
DOI:
10.1016/j.eclinm.2024.102988
Journal:
EClinicalMedicine
Publication Date:
Data Source:
PubMed
Source Link:
View PubMed Record
View Web of Science Record
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Record Created: