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
⇒View Archives here⇐
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
Estelle Russek-Cohen from US Food and Drug Administration .
Paper: Statistical Science at the FDA
I plan on talking about the statistical community at the US Food and Agricultural Administration (FDA) including contributions that FDA statisticians have made to statistical research, the statistical profession and the mission of FDA. Along the way I will highlight a few topics motivated by regulatory concerns. Topics I will mention will be adaptive designs, the increased interest in formulating an estimand when planning a clinical trial, personalized medicine and the role of companion diagnostics, and vaccine safety in postmarket. The latter will include multiple projects that involve the use of “big data”, including data mining in Sentinel, the system used to monitor millions of individuals via claims data. I will also touch base on research funding and training for a career at FDA.