The goal of PROTECT is to strengthen the monitoring of the benefit-risk of medicines in Europe. This will be achieved by developing a set of innovative tools and methods that will enhance the early detection and assessment of adverse drug reactions from different data sources, and enable the integration and presentation of data on benefits and risks.

A methodological framework for pharmacoepidemiological studies will be developed and tested to enable data mining, signal detection and evaluation in various types of datasets, including data of spontaneous reports, registries and other electronic databases.

PROTECT will trial direct patient data collection in natural languages using web-based, telephone and text messaging systems. It will test the transferability of the data into a common language and explore linkages to data from electronic health records and registries.

PROTECT Key Achievements
PROTECT Publications