Efficient Score Statistic in Drug and Vaccine Safety Surveillance

摘要

Surveillance of health care performance indicators is of growing interest as drugs need to be monitored even after they passed phase 3 clinical trials and are on the market. Individuals in small subpopulations may still have adverse reaction to it, and even if no such adverse reaction is present, monitoring is the only way public concerns can be settled. We compare methods using large sample approximations and exact distributions for the likelihood ratio and show that the efficient score vector is just as effective tool. Furthermore, we demonstrate that it can be applied even for data structures that are too complicated for the likelihood ratio. All new monitoring schemes are simple and they can be represented by simple graphs.