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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. These methods will be tested in real-life situations in order to provide all stakeholders (patients, prescribers, public health authorities, regulators and pharmaceutical companies) with accurate and useful information supporting risk management and continuous benefit-risk assessment.
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. Means of combining results from clinical trials, spontaneous reporting and observational data will be developed, comparing Bayesian modelling, multi-criteria decision analysis and other analytical methods. Methods for graphical expression of benefit-risk will be tested with different stakeholders.
Collection of data directly from patients is essential in many situations. 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.
Using methods developed in the project, validation studies performed with additional data resources available in the European Union will help create the foundation for multi-site investigations. Development will continue beyond the initial IMI funding, with training given and results disseminated using the EMEA-led European Network of Centres for Pharmacovigilance and Pharmacoepidemiology and relevant publications.
PROTECT consists of 34 public and private partners coordinated by the European Medicines Agency. It will be managed by a Coordinator and Deputy Coordinator with extensive experience in pharmacovigilance, aided by a strong governance structure, including a Steering Committee, an experienced project management team and a distinguished international External Advisory Board.