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International collaborations

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We collaborate with other databases and experts in multi-country database studies under the principles of the European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP). We are dedicated to excellence in research by adhering to the ENCePP Guide on Methodological Standards and promoting scientific independence and transparency. We have registered studies in the EU PAS register, a publicly accessible resource for the registration of pharmacoepidemiological and pharmacovigilance studies.

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Current collaborations include the European Medical Information Framework (EMIF) funded by the European Innovative Medicines Initiative (IMI), the European Cancer Pharmacoepidemiology Group,the diabetes cancer research consortium and many multi-country database studies where PHARMO takes part either as coordinator or as partner database.

 

 

Current Pan-European studies include:

SAFEGUARD

The SAFEGUARD – Safety Evaluation of Adverse Reactions in Diabetes – project aims to quantify the cardiovascular, cerebrovascular and pancreatic safety risk of T2DM drugs. New safety issues of drugs used in diabetes are constantly arising, such as potential associations with pancreatitis, pancreas cancer, bladder cancer and acute renal failure.For SAFEGUARD a multidisciplinary consortium of 14 centers in Europe, including PHARMO, aims to quantify the cardiovascular, cerebrovascular and pancreatic safety risk of the T2DM drugs, in particular the more novel drugs, by investigating published clinical trials and observational studies, spontaneously reported adverse event reports and data from population-based health care databases capturing longitudinal drug exposure and event data on more than 1.7 million T2DM patients across Europe. The SAFEGUARD consortium will yield a harmonized epidemiological data platform on a large T2DM population, which could easily be used to address newly occurring safety issues in the future.The SAFEGUARD project is funded by the European Commission in the 7th Framework Programme. www.safeguard-diabetes.org

European Medical Information Framework (EMIF)

To help improve access to patient-level data, the European Medical Information Framework (EMIF) was launched beginning of 2013. As part of the broader European Innovative Medicines Initiative (IMI), the EMIF project aims to create an environment that allows for efficient re-use of existing health data. A common Information Framework (EMIF-Platform) will link up and facilitate access to diverse medical and research data sources.To ensure immediate applicability, the EMIF project includes two specific therapeutic research topics that will help guide the development of the Information Framework: the onset of Alzheimer’s Disease (EMIF-AD) and metabolic complications of obesity (EMIF-Metabolics).The project consortium is a partnership between Academia, small and medium sized companies and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and comprises a large number of world-renowned experts in data access and linkage and the Metabolic and AD therapeutic areas from across Europe.To read more about the study, please click here.

Pan European multi-database bladder cancer risk characterisation study

PHARMO is one of the centres involved in the pan-European multi-database bladder cancer risk characterisation study. This observational study, requested by the EMA, is being undertaken to further assess the association between pioglitazone use and bladder cancer risk among patients with type 2 diabetes mellitus in four European countries: Finland, the Netherlands, Sweden and the United Kingdom.To read more about the study, please click here

Comparison of the Risk of Cancer Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments

This is a multinational cohort database study to estimate the incidence of female breast cancer and bladder cancer, by insulin use at cohort entry, in patients who are prescribed dapagliflozin compared to patients prescribed other specific oral antidiabetic drugs to treat type 2 diabetes mellitus. Because of the mechanism of action for dapagliflozin and results from small safety monitoring studies, there is interest in further evaluating the safety of dapagliflozin in large populations.The study is implemented in four administrative health care data sources in three countries: Clinical Practice Research Datalink (CPRD; UK); Centers for Medicare and Medicaid Services (CMS) Medicare databases (US);  HealthCore Integrated Research Database (HIRDSM; US); andthe PHARMO Database Network (NL).This study is registered in the EU PAS Register. To read more, please click here

Evaluation of the Use of Nepafenac in Selected European Populations

This study is a drug utilisation study to evaluate the use of nepafenac (Nevanac), an ophthalmic non-steroidal agent, in two selected European populations in Denmark and The Netherlands. In Europe, nepafenac has been approved for (1) prevention and treatment of postoperative pain and inflammation associated with cataract surgery in adults (approval in 2007) and (2) to reduce the risk of macular edema after cataract surgery in diabetic patients (approval in 2011).The aim of this study is describe the use of nepafenac. This is a cohort study including new users of nepafenac and new users of other selected ophthalmic NSAIDs. The study is conducted in the network of databases from the National Health Databases in Denmark and the PHARMO Database Network in the Netherlands. The study reported the frequency of the demographic characteristics of nepafenac users and users of other selected individual ophthalmic NSAIDs.This study is registered in the EU PAS Register. To read more, please click here

A pharmacoepidemiological study of Rivaroxaban use and potential adverse outcomes in routine clinical pratice in the Netherlands

This prospective cohort study assesses patterns of drug utilisation and to quantify outcomes related to safety and effectiveness in new users of rivaroxaban compared with new users of standard of care in routine clinical practice in the Netherlands. A description will be provided of patients who are prescribed oral rivaroxaban for the first time in comparison with those who are prescribed standard of care for the first time, of the characteristics of rivaroxaban use (including indication, dose and duration) and of time-trends in the characteristics of first-time use of rivaroxaban. The occurrence of hospitalisation for three bleeding events will be studied in comparison with individuals receiving current standard of care.This study is registered in the EU PAS Register. To read more, please click here

A multinational active safety surveillance study of crizotinib in Europe

Crizotinib (XALKORI®), an orally administered selective ATP competitive small molecule inhibitor of the anaplastic lymphoma kinase (ALK), has been approved for the treatment of patients with previously treated locally advanced ALK-positive non small cell lung cancer (NSCLC). This non-interventional Post-Authorisation Safety Study (PASS) examines the safety and effectiveness of crizotinib among ALK-positive NSCLC patients using existing healthcare databases in Denmark, Sweden, Finland, the Netherlands and the United States.

The primary objective of this study is to estimate the incidence of adverse events that were observed in crizotinib clinical trials including 1) hepatotoxicity, 2) pneumonitis/ interstitial lung disease, 3) QT interval prolongation, 4) bradycardia, and 5) vision disorder. Less frequently observed adverse events, i.e. renal cysts, edema, leukopenia, neuropathy, and photosensitivity as well as patient survival will also be examined. To contextualise the incidence of the adverse event in crizotinib treated patients, the incidence of these adverse events in patients prescribed three other orally administered tyrosine kinase inhibitors, ceritinib, erlotinib and gefitinib, will be estimated.

This study is registered in the EU PAS Register. To read more, please click here

Post-approval safety study (PASS) of the utilisation pattern of apixaban in the Netherlands

Apixaban is an orally administered anticoagulant that inhibits coagulation factor Xa. It is currently approved (since 2011) for the prevention of venous thromboembolism (VTE) in patients undergoing total hip arthroplasty (THA) or total knee arthroplasty (TKA). Because VTE prevention is the first approved indication of apixaban, use of apixaban outside this indication is a regulatory concern. To address this concern, a drug utilisation study focusing on off-label use of apixaban in the Netherlands was performed. The overall objective of this study is to describe the utilisation patterns of apixaban in the Netherlands.

This study is registered in the EU PAS Register. To read more, please click here

Drug Utilization Study on Diane®-35 (and generics) in European healthcare databases

Cyproterone acetate (CPA) 2mg, in combination with ethinylestradiol (EE) 35mcg is a medicinal product currently indicated for the treatment of moderate to severe acne and/or for hirsutism in women of reproductive age. Androgen-dependent symptoms such as acne, hirsutism, seborrhea, and alopecia, as well as androgen sensitivity-related symptoms of Polycystic Ovary Syndrome (PCOS) have been considered as potential therapeutic targets for CPA.

Since CPA/EE also acts as a hormonal contraceptive, women should not take this medicine in combination with a hormonal contraceptive. The concomitant use of CPA/EE with a hormonal contraceptive would expose women to a higher hormonal dose and therefore potentially increase the risk of thromboembolism.

The study objectives are to characterize new users of Cyproterone Acetate / Ethinylestradiol (CPA/EE) in 2011/2012 and in 2014 according to demographics, treatment characteristics, previous diagnosis of acne, hirsutism or other hyperandrogenic conditions, previous acne treatment and (concomitant) use of hormonal contraceptives identified in Healthcare Databases in the UK (THIN), the Netherlands (PHARMO) and Italy (HSD).

This study is registered in the EU PAS Register. To read more, please click here