|Project Title||Mini-Sentinel: Continuous versus Group Sequential Analysis for Post-Market Drug and Vaccine Safety Surveillance|
Thursday, March 13, 2014
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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Ivair R. Silva PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA and Department of Statistics, Universidade Federal de Ouro Preto, Ouro Preto, Minas Gerais, Brazil
Martin Kulldorff PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
- Vaccines, Blood & Biologics
- Devices and Radiologic Health