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Expert Workshop on Overcoming Statistical Challenges to the Reuse of Data in the Mini-Sentinel Distributed Database

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    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.


    Mark McClellan MD, PhD, MPA; Engelberg Center for Health Care Reform, Brookings Institution, Washington, DC

    Rachel E. Sherman MD, MPH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD


    Expert Workshop