Titre : Assessing Dunnett and MCP-Mod based approaches in two-stage dose-finding trials 

Auteurs : Jihane AOUNI, Jean Noel BACRO, Gwladys TOULEMONDE, Pierre COLIN, Loic DARCHY, Bernard SEBASTIEN,  

Revue : Biostatistics and Health Sciences 

Numéro : Issue 1 

Volume : 1 

Date : 2019/05/29 

DOI : 10.21494/ISTE.OP.2019.0397 

ISSN : 2632-8291 

Résumé : 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. 

Éditeur : ISTE OpenScience