Overcoming Statistical Challenges to the Reuse of Data within the Mini-Sentinel Distributed Database
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.
Agenda
Overview of Data Reuse Challenges within Mini Sentinel
Perspective on the Context of Drug Safety Evaluation and Data Reuse
Session I: Proposed Solutions for Data Reuse
David Graham
Deputy Chief Operating Officer - Office of Neighborhood Services, City of San Diego
Session II: Scientific Concerns Related to Data Reuse
Session III: Next Steps for Implementation with Mini Sentinel
Lesley Huntley Curtis
Associate Professor in Medicine - Duke University School of Medicine
Jennifer Clark Nelson
Group Health Research Institute
Closing Remarks and Adjournment
Welcome, Introduction, and Expert Workshop Objectives
Rachel Sherman
Principal, Drug and Biological Drug Products - Greenleaf Health LLC
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