Prospective surveillance of vaccine safety by case series analysis
Lead Research Organisation:
The Open University
Department Name: Mathematics & Statistics
Abstract
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Technical Summary
The aim of this project is to develop new techniques for the prospective surveillance of vaccine safety. These new techniques will be based on the self-controlled case series method, which was developed by the applicant and has been widely used in pharmacoepidemiology. This is a method for estimating the relative risk of acute events following transient exposures, using only information on cases. It is thus well-suited for surveillance. The method also controls for non-varying confounders, and hence is less prone to bias than other non-randomised methods.
We shall work towards two related objectives. The first is to develop a method for monitoring the safety of a single product, for example a new vaccine. To this end, we shall adapt the sequential probability ratio test for use with the case series method. The second objective is to develop a method for monitoring a range of products (for example, several childhood vaccines) to identify new problems. This will be based on a version of the cumulative sum method.
The case series method is retrospective. New work is therefore required to adapt it to prospective surveillance. Initial investigations have shown that this is possible, by sequentially inspecting the data at fixed time intervals. Further work is required to fully develop the approach, in particular to allow for age effects, study different inspection intervals, and validate the method fully for use in a surveillance context. This application is for 12 months? funding to support one post-doctoral researcher to undertake the necessary development and validation work.
The project will find applications both for routine vaccine safety surveillance and to more focused surveillance of new products, as undertaken by public health bodies and the pharmaceutical industry. The methods are likely to be applicable to pharmacovigilance more widely.
We shall work towards two related objectives. The first is to develop a method for monitoring the safety of a single product, for example a new vaccine. To this end, we shall adapt the sequential probability ratio test for use with the case series method. The second objective is to develop a method for monitoring a range of products (for example, several childhood vaccines) to identify new problems. This will be based on a version of the cumulative sum method.
The case series method is retrospective. New work is therefore required to adapt it to prospective surveillance. Initial investigations have shown that this is possible, by sequentially inspecting the data at fixed time intervals. Further work is required to fully develop the approach, in particular to allow for age effects, study different inspection intervals, and validate the method fully for use in a surveillance context. This application is for 12 months? funding to support one post-doctoral researcher to undertake the necessary development and validation work.
The project will find applications both for routine vaccine safety surveillance and to more focused surveillance of new products, as undertaken by public health bodies and the pharmaceutical industry. The methods are likely to be applicable to pharmacovigilance more widely.
Organisations
People |
ORCID iD |
| Conor Farrington (Principal Investigator) |