Statistical Methods for Multi-jurisdictional Australian Vaccine Safety Investigations of Rare Adverse Events.

ABSTRACT:

Background

In Australia, surveillance of adverse events following immunisation is primarily conducted by states and territories, with each jurisdiction only able to view and analyse reports originating from their own population. Distributed data models (aka federated data models) are a form of decentralised collaboration, with each site maintaining ownership of its data from end-to-end including data collection, storage and analysis. The primary benefit of this model is that it maintains independence and autonomy while enabling interdependence, collaboration and scalability.

Objective

We aimed to investigate statistical methods for a multi-jurisdictional collaboration when conducting a rigorous assessment of rare adverse events following immunisation at a national level.

SUBMITTER: Morgan HJ 

PROVIDER: S-EPMC12924870 | biostudies-literature | 2026 Mar

REPOSITORIES: biostudies-literature