Open Access Research Article

Utility-Based Dose-Finding in Practice: Some Empirical Contributions and Recommendations

Jihane Aouni1,2, Jean Noel Bacro2, Gwladys Toulemonde2,3 and Bernard Sebastien1

1Sanofi, Research and Development, 91385 Chilly-Mazarin, France

2IMAG, Univ Montpellier, CNRS, Montpellier, France

3Lemon, Inria

Corresponding Author

Received Date: July 24, 2019;  Published Date: August 22, 2019


Aspects related to dose-finding trials are of major importance in clinical development. Poor dose selection has been recognized as a key driver of failures in late phase development programs and postponements in drug approvals. The aim of this paper is to develop a flexible utility-based dose selection framework for phase II dose-finding studies that has satisfactory operating characteristics. This framework also allows to plan interim analyses with stopping rules that can be easily defined and interpreted by the clinical team within this same framework.

Keywords: Adaptive trials; Decision rules; Dose selection; Interim analysis; Utility function

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