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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
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| 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.
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| 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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