This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 26
Type: Topic Contributed
Date/Time: Sunday, August 1, 2010 : 2:00 PM to 3:50 PM
Sponsor: Section on Nonparametric Statistics
Abstract - #306875
Title: Bivariate Semiparametric Bayesian Approach for Finding Minimum Effective Dose and Maximum Safe Dose
Author(s): Satrajit Roychoudhury*+ and Pulak Ghosh
Companies: Novartis Pharmaceuticals Corporation and Indian Institute of Management, Bangalore
Address: , , ,
Keywords: minimum effective dose ; Maximum tolerated dose ; hierarchical bayesian model ; Dirichlet process
Abstract:

In early stage clinical trials the dosing range or therapeutic window is jointly determined by dose-efficacy curve and dose-safety curve. Minimum effective dose(MED) refers to the minimum dose that has clinically significant effect over the placebo/control and maximum tolerated dose (MTD) refers to the maximum dose which is comparably safe with the placebo/active control dose. In this paper a hierarchical semi-parametric bayesian approach is explored to find the MED and MTD simultaneously. Both monotonic and non-monotonic dose response relations are explored. The model described detection of MED and MTD event when the dose effect between different dose groups are heterogeneous. The model is illustrated with simulations and real dose-response data.


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