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
Lilly Yue from U.S. FDA.
Paper: Leveraging “Big Data” for regulatory decision making: Challenges and Opportunities
In this era of “Big Data”, there are many sources of possible real world healthcare data that could be leveraged in the clinical studies in the regulatory settings. While such large quantities of data reflect real world clinical practice and could potentially be used to reduce the cost of clinical trials, challenges arise concerning transforming the real world data into valid scientific evidence and using such evidence in the regulatory decision making. This presentation will discuss the opportunities and challenges from statistical and regulatory perspectives with examples.