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:
Yi Huang (UMBC)
Nagaraj Neerchal (UMBC)
Bimal Sinha (UMBC)
Tze Lai (Stanford)
Phillip Lavori (Stanford)
Ying Lu (Stanford)
Jie Chen (Novartis)
Joseph Heyse (Merck)
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
Lilly Yue from U.S. FDA.
Paper: Challenges and Opportunities in Utilizing National and International Registries to Enhance Medical Product Evaluation
National and international registries provide real world evidence and are playing more and more important roles in enhancing the safety and effectiveness evaluations of medical products. While these registries provide a huge amount of data reflecting real world practice and potentially reduce the cost of clinical trials, challenges arise concerning how to use the data to draw reliable statistical inferences. This presentation will focus on developing innovative analytics - prospectively designing pre-market clinical studies utilizing such registries with propensity score methodology for objective statistical inference.