On September 5, the Engelberg Center for Health Care Reform hosted “Overcoming Statistical Challenges to the Reuse of Data within the Mini-Sentinel Distributed Database” to provide an opportunity for experts in the field to discuss the issue of data reuse and to identify a practical path forward to resolve the challenges. This meeting explored the scientific concerns of data reuse and proposed solutions and next steps for implementation within Mini-Sentinel.
The development of the Mini-Sentinel pilot for medical product safety surveillance marks an important expansion of surveillance capabilities, with the potential for delivering more rapid and actionable information to inform regulators, health professionals, and patients. Accomplishing the goals of active medical product surveillance will require solutions for the statistical challenges presented within Mini-Sentinel.
Overview of Data Reuse Challenges within Mini Sentinel
9:05 am - 9:15 am
Perspective on the Context of Drug Safety Evaluation and Data Reuse
9:15 am - 9:45 am
Session I: Proposed Solutions for Data Reuse
9:45 am - 10:30 am
Session II: Scientific Concerns Related to Data Reuse
10:45 am - 12:00 pm
Session III: Next Steps for Implementation with Mini Sentinel
12:00 pm - 1:00 pm
Welcome, Introduction, and Expert Workshop Objectives
8:45 am - 9:05 am