Big Data Tool for Estimating Baseline Event Rates in Clinical Trials

• Activity Number: 592
• Type: Topic Contributed
• Date/Time: Thursday, August 7, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Roshan Shah and C. Andy Schuetz*+
• Companies: Evidera and Evidera
• Keywords: Cardiovascular ; Baseline event ; Archimedes ; Clinical trial

Abstract

In cardiovascular (CV) safety studies, understanding the baseline CV risk is critical to designing a robust study. Sponsors often have to demonstrate that the difference in the CV risk between placebo and study drug is within a pre-specified boundary, in addition to recruiting a population within reasonable time and budget parameters. In order to achieve this, more advanced methods are necessary to understand how population compositions, i.e. the combinations of I/E criteria and risk factors that define a population, contribute to baseline CV risk. Through understanding the contributions to CV risk for various populations, the scientific and practical aims of the study can be established. Using the Archimedes Model, a continuous time, discrete event simulation model of physiology, disease, interventions, and the healthcare system, in combination with Population Explorer, a real-time analysis and reporting tool, baseline CV risk can be estimated by specifying variations in I/E criteria and risk factors. A presentation of how Population Explorer can estimate CV risk for various populations will be shown, as well as how variations can increase the potential recruitment size.