Event Summary:
A one-day workshop organized by the Center for Interdisciplinary Research and
Consulting at the University of Maryland, Baltimore County (UMBC), and the
Center for Innovative Study Design (CISD) at Stanford University in the field of Clinical Trials and Regulatory Science.
Registration is now closed
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Organizing Committee:
Faculty from UMBC and Stanford University and leaders from FDA and industry.
For more information:
Please contact Dr. Yi Huang, Department of Mathematics and
Statistics, University of Maryland Baltimore County (UMBC),
1000 Hilltop Circle, Baltimore, MD 21250.
E-Mail: yihuang@umbc.edu.
For any Technical difficulties Please contact Zana Coulibaly at czana1@umbc.edu.
Participant Information
Rima Izem from FDA.
Paper: Drug Safety at FDA, Challenges with New Data
This presentation will discuss drug safety, new observational data sources and the statistical challenges in study design and analysis that they bring up. The presentation will start with a quick overview of the scope of statistical review in post-market safety. Under its new authority, FDA created the Sentinel system, a network of large databases with health information that can be quickly queried to assess drug safety. With the new data source come new challenges. These include adapting diagnostics and data analyses to aggregated data to protect patient privacy, adequately balancing the tradeoff between control for confounding and generalizability of results, and evaluating impact of patterns of uptake and real-world adherence to new drugs to typical survival or time-series analyses methods. These challenges will be illustrated with examples from drug safety.