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
Electronic medical records and claims databases provide rich information about medications and outcomes. These databases are an excellent opportunity to investigate associations that were not explored in clinical trials. Questions of interest could involve treatment effect heterogeneity, long-term effects, dynamic treatment strategies, effects in co-morbid populations, and so on. However, use of these data involve unique challenges, including identifying outcomes that have high validity, handling missing data, and informative observation times, along with the usual challenges with observational studies (controlling for confounding). We discuss some of these challenges, propose solutions, and illustrate with some recent examples.