Key issues in performing epidemiological vaccine safety studies
Dr Nick Andrews, Deputy Head, Statistics Modelling and Economics Department, Health Protection Agency joined us at the World Vaccine Congress Lyon to present on the key issues in performing epidemiological vaccine safety studies. An essential part of post licensure vaccine safety surveillance is signal testing using epi-studies. The use of routine data sources along with appropriate statistical methods can provide an efficient way to investigate signals. The key issues include: Defining the question , Data sources, Design issues, Statistical methods and Infrastructure .
This presentation focuses on:
- Lessons from doing over 20 safety studies will be presented
- Key issues will include identifying and defining the safety question, data sources for case finding, study design and statistical methods
- The merits of having an infrastructure for doing safety studies will also be discussed