Open-Source Tools for Monitoring Clinical Trial Safety – Taking it to the Next Level Towards Cross-Functional Collaboration

• Activity Number: 166 - New Developments for Using R in the Biopharmaceutical Industry
• Type: Topic Contributed
• Date/Time: Monday, July 29, 2019 : 10:30 AM to 12:20 PM
• Sponsor: Section for Statistical Programmers and Analysts
• Author(s): Paul Schuette* and Jeremy Wildfire* and Min Lee* and Satha Thill* and Eric Nantz*
• Companies: AbbVie and Amgen and Eli Lilly and FDA and RHO, Inc

Abstract

Clinical trial research is highly regulated and notoriously slow moving. As a result, modern data analysis tools and statistical techniques that have become commonplace in other industries have struggled to achieve broad or consistent adoption. While many commercial analytics frameworks and home-grown solutions exist, they do not always implement best practices for statistical graphics. Further, access to commercial solutions is expensive which makes collaboration across platforms difficult or impossible. The assessment of safety signals in particular is still a largely manual process dependent on huge outputs of safety information. A more open and collaborative environment may be a first step towards modernizing this key clinical trial process. There have been many efforts including the joint ASA/DIA working group on Safety Evaluation and Best Practice which is working to create and promote open source tools and processes that foster inter-disciplinary, cross-regional safety monitoring and management.