Enhancing Quality and Impact of Early Phase Dose-Finding Clinical Trial Protocols: The SPIRIT Dose Finding Extension (SPIRIT-DEFINE) Guidance

Christina Yap*, Moreno Ursino, Olga Solovyeva, Dhrusti Patel, Munyaradzi Dimairo, Christopher J Weir, An-Wen Chan, Thomas Jaki, Adrian Mander, Thomas R. Jeffry Evans, Richard Peck , Kathryn S Hayward, Melanie Calvert, Khadija Rerhou Rantell, Shing Lee, Andrew Kightley, Sally Hopewell, Deborah Ashby, Elizabeth Garrett Mayer , John IsaacsRobert Golub, Olga Kholmanskikh, Dawn P. Richards, Oliver Boix, James Matcham, Lesley Seymour, S. Percy Ivy, Lynley V Marshall, Antoine Hommais, Rong Liu, Yoshiya Tanaka, Jordan Berlin, Aude Espinasse, Johann de Bono

*Corresponding author for this work

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