2015
DOI: 10.48550/arxiv.1503.01978
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Continuous Post-Market Sequential Safety Surveillance with Minimum Events to Signal

Martin Kulldorff,
Ivair R. Silva

Abstract: The CDC Vaccine Safety Datalink project has pioneered the use of near real-time post-market vaccine safety surveillance for the rapid detection of adverse events. Doing weekly analyses, continuous sequential methods are used, allowing investigators to evaluate the data nearcontinuously while still maintaining the correct overall alpha level. With continuous sequential monitoring, the null hypothesis may be rejected after only one or two adverse events are observed. In this paper, we explore continuous sequenti… Show more

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