TY  - Type of reference 
TI  - Assessing Dunnett and MCP-Mod based approaches in two-stage dose-finding trials 
AU  - Jihane AOUNI 
AU  - Jean Noel BACRO 
AU  - Gwladys TOULEMONDE 
AU  - Pierre COLIN 
AU  - Loic DARCHY 
AU  - Bernard SEBASTIEN 
AB  - Identifying the right, or the optimal, dose is one of the major difficulty during drug development. As a
consequence, the dedicated dose-finding study is a key milestone in the drug development and recent methodological progress has been made for the analysis of those studies, in putting more emphasis on the identification of the efficacy dose-response profile. The placebo controlled, parallel group, fixed design is still a standard for the dose-finding studies, but adaptive designs are becoming more attractive in some cirumstances. The aim of this paper is to review the most recent methodologies for adaptive dose-finding trials : those methods are applicable in the cases when one or several doses are dropped after the interim analysis as well when only the patient allocation is modified after the interim analysis. This review is complemented by simulations illustrating the methodologies, including a two-stage version of the MCP-Mod method proposed by the authors. 
DO  - 10.21494/ISTE.OP.2019.0397 
JF  - Biostatistics and Health Sciences 
KW  - Adaptive trials,  Design optimization,  Dose selection,  Dunnett,  MCP-Mod,  Multiple testing,  Two-stage, Essais adaptatifs,  Optimisation du design,  Sélection de dose,  Dunnett,  MCP-Mod,  Tests multiples,  Deux étapes,  
L1  - http://openscience.fr/IMG/pdf/iste_biostat19v1n1_5.pdf 
LA  - en 
PB  - ISTE OpenScience 
DA  - 2019/05/29 
SN  - 2632-8291 
TT  - Évaluation des approches basées sur le test de Dunnett et MCP-Mod dans des essais de détermination de dose en deux étapes 
UR  - http://openscience.fr/Assessing-Dunnett-and-MCP-Mod-based-approaches-in-two-stage-dose-finding-trials 
IS  - Issue 1 
VL  - 1 
ER  -