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Welcome to the PROTECT website!

The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium is a collaborative European project that comprises a programme to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. The European Medicines Agency (EMA) is the coordinator of PROTECT and GSK is the deputy co-ordinator of PROTECT. They manage a multi-national consortium of 34 partners including academics, regulators, SMEs and EFPIA companies


Latest News

March 2014

PROTECT 4th Periodic Project Report. 

The fourth PROTECT project periodic report covering the period 1 September 2012 to 31 August 2013, endorsed by the Innovative Medicines Initiative last December 2013, is now available on the PROTECT website. Please find a summary in the news section.

February 2014


PROTECT has submitted 26 abstracts to the 30th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE), which will be held in Taipei (Taiwan) from 24th to 27th October 2014. You can find more details here.


Janaury 2014

PROTECT WP2/WG3 has published the updated version of the Drug Consumption Databases.

The authors have reviewed, compiled, and updated the knowledge about European sources of data on drug utilisation in the out- and inpatient healthcare setting.  Information is available for Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Slovenia, Spain, Sweden, The Netherlands, and The United Kingdom.  Information was last updated December 2013.

Two documents are available.  A master document organised as a scientific article, with a detailed and accurate account of the information already available, methods to retrieve this information, and a discussion.  And, a country profile document with a summary of the relevant information from the masters document: country’s health system, reimbursement characteristics, and a list of websites of interest, summarised by country.

These documents are a shared resource for researchers, regulatory agencies, and pharmaceutical companies. They can be found here.


November 2013

PROTECT WP 3.7 has published two studies on the masking effect of measures of disproportionality analyses.

The authors of these studies have developed and validated a mathematical algorithm aimed at identifying the presence, direction and magnitude of a masking effect associated with the use of quantitative methods based on disproportionality analysis (ROR, PRR and RRR). This algorithm has been used on two spontaneous reporting databases (EudraVigilance and Pfizer databases). The study suggests that important masking associated with a single (highest) masking product might be rare, is induced by products for which the reaction is known or has been extensively or over reported. The masking mainly affects events rarely reported in the database. These two studies have been published in Pharmacoepidemiology and Drug Safety. They can be found here.



November 2013


PROTECT publishes the final recommendations Report from WP5 on the IMI-PROTECT Benefit Risk.


The Report "Recommendations for the methodology and visualisation techniques to be used in the assessment of benefit and risk of medicines" can be found here.



October 2013


PROTECT publishes presentations and posters from the 29th ICPE Meeting.

Presentations and posters from the 29th ICPE Meeting held in Montreal on the 25-28 August 2013 are now on line on THE PROTECT website.



                                                                                          Please find them here.


May 2013

PROTECT publishes reviews of benefit - risk methods and results of real-life case studies


PROTECT has published reviews of available methodologies for the assessment, integration and visualisation of the benefit-risk of medicines, as well as recommendations on methods of graphical expression for use by patients, healthcare providers, the pharmaceutical industry and regulators. Results of real-life case studies comparing methods with different levels of complexity are also posted. These case studies were conducted in two waves and concern the following medicines: efalizumab, natalizumab, rimonabant, rosiglitazone, telithromycin and warfarin.

                                                                                 The reports are available here.


May 2013

PROTECT at 29th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (25-28 Aug 2013, Montreal)

Twenty-nine (29) abstracts have been accepted for ICPE 2013. This include the Symposium “De Groot M et al, Improving consistency in findings from pharmacoepidemiological studies: the IMI-PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) project”.

The following abstracts have been accepted for oral or poster presentations:


Framework for pharmacoepidemiology studies

Work Package 2

- Abbing-Karahagopian V, Antidepressant prescribing in five European countries: application of common definitions to assess exposure prevalence - poster

- Afonso A et al, Comparison of six electronic healthcare databases in Europe using standardized protocols: a descriptive study on the incidence of cancer - poster

- Ali M.S. et al., Quantitative Verification of Instrumental Variables Assumption Using Balance Measures - poster

- Ali M.S. et al, Assessment of balance in propensity score analysis in the medical literature: a systematic review - poster

- Ballarin et al, Epidemiologic Measures of Drug use: Antiepileptic drugs, benzodiazepines, and antidepressants in four European countries - poster

- Brauer R et al, Prevalence of antibiotic use: A methodological comparison across various European health care data sources - poster

- De Groot M et al, Antiepileptic drug use in seven electronic health record databases in Europe: A methodological comparison - poster

- De Groot M et al, Comparison of seven electronic healthcare databases in EU countries using a standardized methodology; a descriptive study on the exposure to calcium-channel blockers (CCBs) - poster

-  Ferrer et al, Antiepileptic drugs and suicide: a systematic review - poster

- Groenwold RHH et al, Impact of censoring on estimates of adverse drug effects: a simulation study - poster

- Huerta C et al, Prevalence of use of benzodiazepines and related drugs in seven European databases: A cross-national descriptive study from the PROTECT-EU Project - poster

- Rañopa M et al, Conflicting Results among Observational Studies Investigating Statin Use and Cancer risk: a Systematic Review - poster

- Rañopa M et al,, The Identification of Incident Cancers in UK Primary Care Databases: A Systematic Review - poster

- Requena G et al, Trends in incidence rates (IR) of hip/femur fractures in 5 European countries: a comparison using electronic health care records (e-HCR) - poster

- Rottenkolber M et al, Prevalence of inhaled long-acting beta-2-adrenoceptor–a comparison of seven European databases - poster

- Rottenkolber M et al, Association between bronchodilator treatment and myocardial infarction in COPD patients: a structured assessment of systematic reviews and meta-analyses - poster

- Sabate et al, Assessing quality in systematic reviews of adverse effects - poster

- Sanni M et al, Balance Measures for Determining Optimal Caliper Width in Propensity Score Matching: a simulation study - poster

- Uddin M J et al, Application of Instrumental Variables Analysis in Pharmacoepidemiology: an Example of Beta2-Agonist Use and Myocardial Infarction - slide presentation


Methods for Signal Detection

Work Package 3

- Edwards IR et al, Risk identification in Healthcare Records: comparison to epidemiological studies - poster

- Slattery J et al, A comparative evaluation of disproportionality measures in EudraVigilance – striking variability with time on market

- Tregunno P et al, Hit-miss model detects duplicates missed by rule-based screening of individual case safety reports - poster


Benefit- Risk integration and representation

Work Package 5

- van den Ham H.A. et al, Balancing individual benefits and risks of warfarin in patients with atrial fibrillation - poster

Replication Studies

Work Package 6

- Astrup A et al, Impact of censoring at or truncating risk time of hospitalizations on the effect measure of the association between antiepileptic drugs (AED) and suicide attempt - poster

- Gasse Ch et al, Impact of previous suicide attempts and family history of psychiatric disease on the size of the association between antiepileptic drugs and suicide related events - poster

- Grimaldi - Bensouda L et, Risk of suicide attempts associated with antiepileptic drugs: a case-control study looking at the effect of differing design options - poster

- Tcherny - Lessenot et al, Replication study on the risk of liver injury associated with the use of antibiotics using a US database with linkage with hospital data- poster and presentation

- Udo R et al, Validation of hospital discharge diagnoses and liver related laboratory measurements to identify patients with idiopathic acute liver injury- poster


                                                             29th ICPE Meeting, Montreal,, 25-28 August


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