Continuous versus group sequential analysis for post-market drug and vaccine safety surveillance.

ABSTRACT: The use of sequential statistical analysis for post-market drug safety surveillance is quickly emerging. Both continuous and group sequential analysis have been used, but consensus is lacking as to when to use which approach. We compare the statistical performance of continuous and group sequential analysis in terms of type I error probability; statistical power; expected time to signal when the null hypothesis is rejected; and the sample size required to end surveillance without rejecting the null. We present a mathematical proposition to show that for any group sequential design there always exists a continuous sequential design that is uniformly better. As a consequence, it is shown that more frequent testing is always better. Additionally, for a Poisson based probability model and a fl

SUBMITTER: Silva IR 

PROVIDER: S-EPMC4888780 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature