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
Jason Roy from University of Pennsylvania.
Paper: Drug safety and effectiveness studies using large healthcare databases: challenges and opportunities
Large healthcare databases, such as claims and EHRs, are potentially rich sources of information about the safety and effectiveness of drugs. However, because these data were not collected primarily for research purposes, there are a number of challenges. These include missing data, informative observations times, confounding, uncertainty about the validity of outcomes, and variations in laboratory data collection methods. In this talk we outline some of the challenges, potential solutions, and illustrate the ideas with results from several current and recent postmarketing safety studies.