Model-Based Approach to Predict Adherence to Protocol During Antiobesity Trials.

ABSTRACT: Development of antiobesity drugs is continuously challenged by high dropout rates during clinical trials. The objective was to develop a population pharmacodynamic model that describes the temporal changes in body weight, considering disease progression, lifestyle intervention, and drug effects. Markov modeling (MM) was applied for quantification and characterization of responder and nonresponder as key drivers of dropout rates, to ultimately support the clinical trial simulations and the outcome in terms of trial adherence. Subjects (n = 4591) from 6 Contrave^® trials were included in this analysis. An indirect-response model developed by van Wart et al was used as a starting point. Inclusion of drug effect was dose driven using a population dose- and time-dependent pharmacodyna

SUBMITTER: Sharma VD 

PROVIDER: S-EPMC5811797 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature