Simulation of Safety Data for Clinical Trials

• Activity Number: 547
• Type: Contributed
• Date/Time: Wednesday, August 7, 2013 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Scott Diegel*+ and John Kloke and Neil Baron
• Companies: University of Wisconsin and University of Wisconsin and University of Wisconsin
• Keywords: Clinical trials ; Simulation ; Interim monitoring

Abstract

Monitoring of interim clinical trial data for safety and efficacy is a crucial part of the drug development process. Trial summary data is available in published manuscripts; however, data at the individual subject-level is typically confidential and proprietary. To develop and evaluate new statistical methods for monitoring safety in clinical trials, it is important to have access to realistic data. It is also important to have sources of realistic data for training as well as educational purposes. We are developing a software package to simulate realistic interim clinical trials data. The algorithm steps through each of the main components of a clinical trial. Key dates, subject status, adverse events, and demographic data, as well as other important subject-specific information are generated. The software will be modular so that steps can easily be added or modified as desired. We utilize publicly available demographic information and summary statistics and models from the literature that summarize actual studies as the basis for simulation. In this poster presentation we describe the methods in more detail and discuss the similarities of our simulated data to actual results.