Operational Benchmarks for Clinical Trials

• Activity Number: 616
• Type: Contributed
• Date/Time: Wednesday, August 12, 2015 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Steven Schwager* and Joshua Hartman and John Savage and David Lee
• Companies: Medidata Solutions and Medidata Solutions and Medidata Solutions and Medidata Solutions
• Keywords: clinical trials

Abstract

Clinical trials operations managers must understand the performance of their organizations. They need a set of metrics that measure efficiency in every stage of the process. Considering these metrics across a set of relevant dimensions will enable action to systematically improve performance. Dimensions include phase, therapeutic area, indication group, geographic region, and country. Granularity levels include sponsor, TA, study, and site. Using industry-wide data, we present a web-based dashboard that gives a summary visualization of metrics for a specific company and for the industry, displaying the company's relative performance. Substantial performance gaps are visually differentiated from smaller gaps and areas where the company performs well. The dashboard also enables views by therapeutic area or geographic region. Results may be filtered by time and phase. Additional detail for any company rank can be obtained for all metrics. The detailed visualization displays the range of performance for all selected metrics. The view can be narrowed to a specific indication group or country, or to the performance for one or more studies relative to similar studies by other companies.