Speaker Abstract: Breakout Session B
Modeling & Simulation Across Pharmaceutical Boundaries

Computer-Assisted Trial Design (CATD) can be used to test a variety of "what if" scenarios related to specific trial design issues and drug characteristics. By using CATD, the drug development team can determine the range of plausible results a trial would produce prior to actually conducting the trial. A model of drug action and disease response that integrates current knowledge and assumptions is required to explore the different "what if" scenarios. The incorporation of CATD in the development process can result in better decision making on drug dosing and trial design because of better use of available knowledge and ability to explore the importance of a large amount of drug and trial design variables. For example, CATD can be used in drug development:

• To optimize the design of several key trials in the drug development program, for example apply CATD to design major phase II-III efficacy trials when the cost of a non-definitive result is highest.
• To evaluate the potential range of treatment outcomes (including clinical effect and potential side-effects) across the patient population as a function of dose and patient characteristics.
• To evaluate the sensitivity of trial results and the sensitivity of the power of the trial to design parameters and operational variability (variability due to poor compliance and dropouts).
• To evaluate the sensitivity of trial results and the sensitivity of the power of the trial to model assumptions and model uncertainties.
• To formalize assumptions made for a specific trial
• To compare predictions based on simulations to actual results of completed trials.
• To design marketing-support studies, which are concerned with the objective demonstration of a drug's positive attributes to differentiate one product from another.
• As a platform for sharing knowledge and discussing proposed trial designs and analysis within the drug development company's and with the FDA.