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®SCS Capabilities — Computer Assisted Trial Design (CATD) and Analysis
Many compounds are terminated because of inappropriate trial design, particularly incorrect dose selection, mis-specified trial power, and mismatched patient inclusion and exclusion criteria.
To optimize designs of clinical trials and programs, Pharsight® has pioneered Computer-Assisted Trial Design (CATD). CATD provides pharmaceutical and biotechnology companies with:
Rational clinical trial designs based on:
- Models that incorporate all available knowledge
- Software tools that simulate these models to anticipate the likely range of trial outcomes
CATD can be applied to characterize and minimize the risk of trial failures by conducting computerized “virtual clinical trials” before embarking on costly and time-consuming trials.
Clinical development scientists and researchers can quickly test multiple "what if" scenarios, can consider the effects of different assumptions and trial designs, including inclusion/exclusion criteria, and can propagate the uncertainty in the dose-response relationship to trial outcome. Simulations are updated as relevant dose-response information emerges. Trial and program decisions can be made on a quantitative basis, increasing the likelihood that each trial will give definitive results and lead to a successful clinical program.
With our scientific tool Pharsight Trial Simulator™, Pharsight has helped leading pharmaceutical companies increase the likelihood of success in a range of clinical programs by enabling clinical project teams to assess decisions and make informed decisions quickly. Pharsight also has expertise in adaptive trial design strategies that use modeling and simulation, Bayesian methods and decision analysis.
The benefits of using CATD are faster time-to-market, fewer failed studies, and more effective use of clinical study enrollees.