A systems approach to designing effective clinical trials using simulations.

ABSTRACT:

Background

Pharmacogenetics in warfarin clinical trials have failed to show a significant benefit in comparison with standard clinical therapy. This study demonstrates a computational framework to systematically evaluate preclinical trial design of target population, pharmacogenetic algorithms, and dosing protocols to optimize primary outcomes.

Methods and results

We programmatically created an end-to-end framework that systematically evaluates warfarin clinical trial designs. The framework includes options to create a patient population, multiple dosing strategies including genetic-based and nongenetic clinical-based, multiple-dose adjustment protocols, pharmacokinetic/pharmacodynamics modeling and international normalization ratio prediction, and various types of outcome m

SUBMITTER: Fusaro VA 

PROVIDER: S-EPMC3747989 | biostudies-literature | 2013 Jan

REPOSITORIES: biostudies-literature