Computer Simulation and Modeling of Clinical Trial in Drug Development

Author: Lan Yang, BS

Primary Advisor: Jiajie Zhang, PhD

Committee Members: Kathy A. Johnson, PhD

Masters thesis, The University of Texas School of Health Information Sciences at Houston.

Clinical trial is a multi-step process to determine the safety and efficacy of a new drug. It costs up to millions of dollars and several years to conduct a full clinical trial. Computer simulation of a single phase or full process of clinical trials can significantly reduce the cost and save the time for drug development. The simulation is based on various models such as drug action, disease progression, and trial execution. These models are mechanistic or empirical models, which can be constructed according to pharmacokinetic and pharmacodynamic data of the drug or experimental testing results. Several commercial software products have been developed and released to conduct the modeling and simulation of clinical trials and some successful examples have been reported. Pharmaceutical industry is becoming more interested in this in silico strategy for clinical trial, or computer-aided trial design (CATD) technology. However, validation of the models and simulation results represent a challenge in this field. Resource sharing becomes one of the key issues to further expand the scope and applicability of the technology. Although computer simulation can not totally replace the real clinical trials, the new development of pharmacogenetics opens an avenue for CATD in the future.