Clinical Trial Modeling and Simulation—Work in Progress *

Suboptimal clinical trials and data management are critical concerns to the pharmaceutical industry, where there is increasing pressure to contain costs, drive profits, and expedite drug development. Using data from three completed trials of a central nervous system drug, a collaborative effort between Zeneca Pharmaceuticals and the Center for Drug Development Science at Georgetown University Medical Center is being made to develop computer-assisted simulation models that predict outcomes measures of clinical trials. The objectives for this project are to more fully understand computer-assisted modeling and simulation techniques (including steps and assumptions made), their application in the design of clinical trials, and their potential impact on the drug development process. Using mixed-effects pharmacokinetic/pharmacodynamic modeling and Bayesian techniques, models were built showing a relationship between predicted and measured drug concentrations and between predicted and measured Brief Psychiatric Rating Scale scores. Although the work is ongoing, it has yielded valuable insight into how clinical trial modeling and simulation may contribute to more efficient drug development.