EMA to assess results of EU pharmacoepidemiological research project

Published: 28-Mar-2015

PROTECT project was launched to develop ways to monitor the benefits and risks of medicines marketed in Europe


A five-year pharmacoepidemiological research project on the outcomes of therapeutics aimed at strengthening the assessment of medicines has wrapped up, with the European Medicines Agency (EMA) planning to review results this year.

The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) project was launched to develop innovative ways to monitor the benefits and risks of medicines marketed in Europe.

'PROTECT results may significantly influence practices in pharmacovigilance and benefit-risk evaluation. Therefore, during 2015, EMA will systematically scrutinise PROTECT’s research outputs in order to identify priority results that are robust and which if implemented, have the greatest potential to positively impact public health,' the Agency said.

This included methods such as enhancing early detection and assessment of adverse drug reactions from data sources including clinical trials and observational studies; establishing a framework for pharmacoepidemiology studies; and exploring how benefit-risk methods can be integrated into scientific assessment of medicines and communicating the benefits and risks.

It also examined new methods for collecting data from consumers, which is 'essential in many situations', according to project documents. PROTECT had aimed to trial directing data collected in patients’ own language by using web-based, telephone and text messaging systems. It tested to what extent data can be transferred into one common language to allow researchers to explore linkages to data from electronic health records and registries. The project was a public-private partnership of 34 European partners, and was coordinated by the EMA and GlaxoSmithKline.

The EU’s Innovative Medicines Initiative joint undertaking funded the project, which had a budget of €29.81m.

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