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Objectives of PROTECT

The overall objective of PROTECT is to strengthen the monitoring of the benefit-risk of medicines in Europe. In order to achieve this overall goal, PROTECT has been designed as a comprehensive and integrated project aiming to develop and validate a set of innovative tools and methods that will:

  • Enhance data collection directly from consumers of medicines in their natural language in several European Union countries, using modern tools of communication;
  • Improve early and proactive signal detection from spontaneous reports, electronic health records and clinical trials;
  • Develop, test and disseminate methodological standards for the design, conduct and analysis of pharmacoepidemiological studies applicable to different safety issues and using different data sources;
  • Develop methods for continuous benefit-risk monitoring of medicines, by integrating data on benefits and risks from clinical trials, observational studies and spontaneous reports, including both the underpinning modelling and the presentation of the results, with a particular emphasis on graphical methods;
  • Test and validate various methods developed in PROTECT using a large variety of different sources in the European Union (e.g. clinical registries) in order to identify and help resolve operational difficulties linked to multi-site investigations.