Using Simulations To Optimize The Design Of Clinical Trials

Clinical trial simulations can be used to predict study results and guide the selection of study design parameters under multiple scenarios. To better cope with the rising cost of drug development and efficiently allocate budgets and resources, it is important to ensure that a study answers the questions it was designed to address, such as:

• Maximum tolerated dose
• True shape of the dose response curve
• Statistically significant difference in response between the investigational and comparator treatment

In this white paper, PPD statistical and clinical development experts discuss how simulations can optimize traditional and adaptive clinical trial designs to identify potential gaps in a development plan and reduce the likelihood of an inconclusive study.