Optimization as a Practical Tool in Clinical Trial Design

• Activity Number: 616
• Type: Contributed
• Date/Time: Thursday, August 2, 2012 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Walter Boyle*+
• Companies: SAS Institute
• Keywords: Optimization ; Trial Design ; Clinical Trials ; Simulation ; Forecasting ; Analytics

Abstract

In the hierarchy of analytics maturity optimization typically represents the pinnacle of sophistication and capability. A variety of steps and improvements to current processes are required to reach this level; ranging from changing the decision making process to refining the data gathering and analytics. Specifically, optimization is best predicated upon a thorough system of forecasting, predictive modeling, segmentation and analytics combined with an engaged work force willing to integrate validation, calibration and exploration into the day to day process. This talk will cover the general concept of what optimization is, what it means, and how it can be deployed in the life sciences illustrated by an example in trial drug supply optimization. The example will demonstrate how different types of analytics build together to develop the necessary underpinnings to optimize the manufacture, distribution and resupply algorithm for a clinical trial. This presentation will not focus on the mathematical theory of optimization and but rather the data drive process which paves the way for its utilization.