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CBER BEST Seminar Series - Addressing Selection and Confounding Bias in Test-Negative Study Designs for Flu and COVID-19 Monitoring
Background: The CBER BEST Initiative Seminar Series is designed to share and discuss recent research of relevance to ongoing and future surveillance activities of CBER regulated products, namely biologics. The series focuses on safety and effectiveness of biologics including vaccines, blood components, blood-derived products, tissues and advanced therapies. The seminars will provide information on characteristics of biologics, required infrastructure, study designs, and analytic methods utilized for pharmacovigilance and pharmacoepidemiologic studies of biologics. They will also cover information regarding potential data sources, informatics challenges and requirements, utilization of real-world data and evidence, and risk-benefit analysis for biologic products. The length of each session may vary, and the presenters will be invited from outside FDA. Please see the details below for our upcoming seminar. Anyone can register and join for free. Stay tuned for more details and additional webinars during the year.

Topic: Addressing Selection and Confounding Bias in Test-Negative Study Designs for Flu and COVID-19 Monitoring

Speaker: Dr. Eric Tchetgen Tchetgen
Luddy Family President’s Distinguished Professor, the Wharton School of the University of Pennsylvania

Description: The test-negative design (TND) has become a standard approach to evaluate vaccine effectiveness against the risk of acquiring infectious diseases such as Influenza, Rotavirus, Dengue fever and more recently COVID-19 in real world settings. Despite the TND's potential to reduce unobserved differences in healthcare seeking behavior (HSB) between vaccinated and unvaccinated subjects, substantial variability in unobserved HSB may remain among study participants. As latent HSB is likely also a strong predictor of selection into the TND sample, confounding bias of the vaccine's causal effect by latent HSB may be induced by collider stratification bias resulting from the TND.

Apr 27, 2022 11:00 AM in Eastern Time (US and Canada)

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