Informatics Research Seminar: Leveraging electronic health care data for medical product safety: The Mini-Sentinel Experience

August 26 @ 4:00 – 5:00 pm


Speaker: Leslie Curtis, PhD
Presented from Duke University

Broadcast Link: Seminar



Mini-Sentinel is a pilot project sponsored by the US Food and Drug Administration to create an active surveillance system to monitor the safety of FDA-regulated medical products. Routinely collected electronic healthcare data are at the foundation of the system. Mini-Sentinel uses a distributed data approach in which Data Partners retain physical control over their data, execute standardized programs within their own institutions and, in most cases, share aggregate results.


Lesley H. Curtis, PhD, is professor in medicine at the Duke University School of Medicine and directs the Center for Pragmatic Health Services Research in the Duke Clinical Research Institute.

A health services researcher by training, Dr. Curtis oversees a portfolio of projects that use observational data to address questions related to clinical and comparative effectiveness, pharmacoepidemiology, health care delivery, and epidemiological trends. Dr. Curtis has considerable experience analyzing Medicare claims data, large clinical registries, and prescription drug data, and has led the linkage of large clinical registries with longitudinal Medicare claims data.  In addition, Dr. Curtis has been responsible for the linkage of those data with longitudinal cohorts in the Cardiovascular Health Study, the Framingham Heart Study, the Jackson Heart Study, and the Multi-Ethnic Study of Atherosclerosis (MESA).

Experienced in facilitating large-scale multi-institutional research through the use of distributed health data networks, Curtis co-leads the Data Core for the FDA’s Mini-Sentinel Initiative, co-leads the Electronic Health Record Core for the NIH’s Health Care Systems Collaboratory, and co-leads the Data Standards, Security, Networking, and Infrastructure Task Force for the Patient-Centered Outcomes Research Initiative’s National Clinical Research Network.