Yap, Christina 
; Rekowski, Jan ; Ursino, Moreno ; Solovyeva, Olga ; Patel, Dhrusti ; Dimairo, Munyaradzi ; Weir, Christopher J ; Chan, An-Wen ; Jaki, Thomas ; Mander, Adrian ; Evans, Thomas R Jeffry ; Peck, Richard ; Hayward, Kathryn S ; Calvert, Melanie ; Rantell, Khadija Rerhou ; Lee, Shing ; Kightley, Andrew ; Hopewell, Sally ; Ashby, Deborah ; Garrett-Mayer, Elizabeth ; Isaacs, John ; Golub, Robert ; Kholmanskikh, Olga ; Richards, Dawn P ; Boix, Oliver ; Matcham, James ; Seymour, Lesley ; Ivy, S Percy ; Marshall, Lynley V ; Hommais, Antoine ; Liu, Rong ; Tanaka, Yoshiya ; Berlin, Jordan ; Espinasse, Aude ; de Bono, Johann
; Rekowski, Jan ; Ursino, Moreno ; Solovyeva, Olga ; Patel, Dhrusti ; Dimairo, Munyaradzi ; Weir, Christopher J ; Chan, An-Wen ; Jaki, Thomas ; Mander, Adrian ; Evans, Thomas R Jeffry ; Peck, Richard ; Hayward, Kathryn S ; Calvert, Melanie ; Rantell, Khadija Rerhou ; Lee, Shing ; Kightley, Andrew ; Hopewell, Sally ; Ashby, Deborah ; Garrett-Mayer, Elizabeth ; Isaacs, John ; Golub, Robert ; Kholmanskikh, Olga ; Richards, Dawn P ; Boix, Oliver ; Matcham, James ; Seymour, Lesley ; Ivy, S Percy ; Marshall, Lynley V ; Hommais, Antoine ; Liu, Rong ; Tanaka, Yoshiya ; Berlin, Jordan ; Espinasse, Aude ; de Bono, Johann 
Abstract
SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 provides guidance for clinical trial protocol writing. However, neither the original guidance nor its extensions adequately cover the features of early phase dose-finding trials. The SPIRIT Dose-finding Extension (DEFINE) statement is a new guideline that provides recommendations for essential items that should be ...
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