Using Pharsight® Trial Simulator™

The Pharsight Trial Simulator enables your drug development team to test proposed clinical trials in a series of "what if" scenarios. This process, called Computer-Assisted Trial Design (CATD), consists of performing a series of Monte Carlo simulations of a clinical trial to approximate the distribution of possible outcomes for that trial. The simulations are based on a stochastic model describing drug disposition and effects over time in a single subject, based on subject characteristics and other influences. The model encapsulates known sources of variability, and formalizes assumptions about unknowns. By repeating the simulations over a range of values for key model and trial design parameters, the development team can test the impact of specific design elements and sources of variability or uncertainty on trial outcomes and power. The Trial Simulator is organized so that the CATD process can be carried out by a single user or divided among members of the development team to take advantage of each contributor’s expertise.

CATD can be applied by the clinical development team to characterize and minimize the risk of trial failures by conducting computerized "virtual clinical trials" before embarking on the clinical trial process.  You can quickly test multiple assumptions to optimize the design of individual trials, increasing the predictability of the process and the likelihood that each trial will give definitive results and lead to a successful clinical program.

For a detailed view of the Pharsight Trial Simulator, see:

Guided Tour

An online overview of the main functions of Trial Simulator.

Detailed Quick Tour

Download this PDF file to take a step-by-step tour through a simplified Trial Simulator project.