Key regulatory science results of the PROTECT project published

Since 2009, the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) has generated a significant amount of scientific research in pharmacovigilance, pharmacoepidemiology and benefit-risk evaluation, including 72 original articles in peer-reviewed scientific journals, as well as 14 doctoral theses and 3 master theses carried out in universities across the EU.

In a special issue of the journal Pharmacoepidemiology and Drug Safety published this week, a series of 16 articles provide guidance for observational studies on medicines in several databases and several countries with common protocols. This guidance aims to increase consistency in findings from safety studies and revealing causes of differential drug effects, and will lead to updates to the methods guide of ENCePP. Other key recommendations published recently include a comprehensive review of good detection practices that identified significant improvements to signal detection methods, recommendations for benefit-risk assessment methodologies and visual representations based on real-world case examples to facilitate clear and transparent decision-making, and new methods to collect data directly from patients, including via the internet, applied to the collection of information from pregnant women via the web to better understand the safety of medicines during pregnancy.

Related information: EMA press release| Main results of the four key publications| PROTECT website| PROTECT benefit-risk website