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Activity Number: 321 - Causal Inference in Vaccine Trials and Outbreak Investigations: Epidemiologic Study Design and Statistical Analysis
Type: Invited
Date/Time: Tuesday, July 30, 2019 : 10:30 AM to 12:20 PM
Sponsor: Section on Statistics in Epidemiology
Abstract #300532 Presentation
Title: Chasing Cases: Customizing Vaccine Trials for Emerging Infectious Diseases
Author(s): Natalie E Dean* and M Elizabeth Halloran and Ira M. Longini
Companies: University of Florida and University of Washington and Fred Hutchinson Cancer Research Center and University of Florida
Keywords: vaccine efficacy; emerging pathogens; trial planning; sequential monitoring; test negative design

Outbreaks of emerging infectious diseases pose a critical threat to human health. Rapid evaluation of targeted vaccine candidates is crucial for reducing transmission and preventing future outbreaks, but it is challenging to plan adequately powered vaccine trials due to the unpredictable spatiotemporal incidence of disease. The standard clinical trial paradigm is inadequate in these settings. To maximize power to detect vaccine efficacy, trial protocols must be adequately flexible, adding study populations in response to the evolving outbreak and allowing the trial to extend across outbreaks until the scientific questions are addressed. We discuss several disease-specific examples of vaccine trial strategies for emerging infectious diseases. Challenges in sequential monitoring are considered. Where randomized clinical trials are severely underpowered or otherwise deemed unethical, observational studies such as the test negative design can yield critical data on vaccine effectiveness. We discuss considerations for applying the test negative design in these settings.

Authors who are presenting talks have a * after their name.

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