Mini-Sentinel: Continuous Versus Group Sequential Analysis for Post-Market Drug and Vaccine Safety Surveillance

This report compares the use of continuous and group statistical analysis for prospective post-market vaccine and drug safety surveillance based on observational electronic health data. The comparison focuses on 1) type 1 error, 2) statistical power, 3) the expected time to signal when the null hypothesis is rejected, and 4) the sample size required to end surveillance without rejecting the null.

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