IMI Members
PROTECT
Pharmacoepidemiological research on outcomes of therapeutics by a European consortium
Summary
The PROTECT project will enhance the monitoring of the safety of medicinal products. It will also contribute to better evaluate and communicate their benefit-risk profile throughout their lifecycle. To this end, innovative tools and methodological standards will be developed. The European Medicines Agency coordinates PROTECT and manages a Consortium of 29 public and private participants.
PROTECT aims at explaining discrepancies between the reported outcomes from pharmacoepidemiology studies by studying combinations of drugs and adverse events in several databases. It will identify and further explore sources of variability that may currently affect drug safety studies. Modern ways of collecting data on medication, lifestyle and risk factors directly from consumers using internet and telephony will also be explored in 4 countries with 5600 pregnant women. The ability of these systems to collect regular,
accurate and complete reporting without the intervention of health professionals will be tested. Good practice recommendations for the detection of safety signals are developed based on extensive testing of existing and new methods, creation of a database of known adverse drug reactions, and exploring the use of electronic health records and clinical trials data. In addition, PROTECT will use new modeling approaches to integrate existing information from various data sources to facilitate and enhance the continuous monitoring of the benefit-risk of medicines. Particular emphasis will be given on a graphical representation of benefit-riskprofiles for use by patients, healthcare professionals, regulatory agencies, and drug manufacturers.
Participants
EFPIA member companies
- GlaxoSmithKline Research and Development LTD, Brentford, UK
- Amgen NV, Brussels, Belgium
- Bayer Schering Pharma AG, Berlin, Germany
- AstraZeneca AB, Södertälje, Sweden
- Genzyme Europe B.V., Naarden, The Netherlands
- H. Lundbeck A/S, Valby, Denmark
- Merck KGaA, Darmstadt, Germany
- Novartis Pharma AG, Basel, Switzerland
- Novo Nordisk A/S, Bagsvaerd, Denmark
- Pfizer Limited, Sandwich, United Kingdom
- F. Hoffmann-La Roche AG, Basel, Switzerland
- Sanofi-Aventis Research and Development, Chilly-Mazarin, France
Universities, Research Organisations, Public Bodies & Non-Profit
- European Medicines Agency
- Lægemiddelstyrelsen (Danish Medicines Agency, Copenhagen, Denmark
- Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain
- Fundación Centro Español de Investigación
- Farmacoepidemiológica, Madrid, Spain
- Fundació Institut Català de Farmacologia, Barcelona, Spain
- International Alliance of Patients’ Organizations, London, UK
- Imperial College of Science, Technology & Medicine, London, UK
- Institut National de la Santé et de la Recherche Médicale, Paris, France
- Ludwig-Maximilians-Universität München, München, Germany
- Mario Negri Institute for Pharmacological Research, Milan, Italy
- Medicines and Healthcare products Regulatory Agency, London, UK
- Rijksuniversiteit Groningen, Groningen, The Netherlands
- Stiftelsen WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
- University of Newcastle upon Tyne, Newcastle upon Tyne, UK
- Universiteit Utrecht, Utrecht, The Netherlands
SMEs
- LA Santé Épidémiologie Evaluation Recherche, Paris, France
- Outcome Europe Sarl, St. Prex, Switzerland
Facts & Figures
| Start date | 01/09/2009 |
| Duration | 60 months |
| Contributions | € |
| IMI funding | 11 009 715 |
| EFPIA in kind | 9 984 734 |
| Other | 8 816 164 |
| Total costs | 29 810 613 |
Contact
Project Coordinator
Xavier Kurz
European Medicines Agency
Pharmacovigilance and Risk Management
London
United Kingdom
EFPIA
Elizabeth Swain
GlaxoSmithKline Research and Development
LTD,
Harlow
United Kingdom
Managing entity of IMI beneficiaries
Per Helboe
Danish Medicines Agency, Licensing Division
Copenhagen
Denmark
Innovative Medicines Initiative 2010