The EU-ADR Alliance offers highest standard observational research using multi-database approach with routinely collected data and advanced technology to answer pharmacoepidemiological and drug safety questions

Our databases include about 20 million of active multi-country population

The EU-ADR Alliance provides a unique amalgamation of expertise with a solid governance structure and tested working methods

Our federated databases network is managed by an Honest Broker to ensure the highest standards from the study request to the study closure

BACKGROUND

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WHAT IS EU-ADR-ALLIANCE?

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OUR PRINCIPLES

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What is the EU-ADR Alliance?

The EU-ADR Alliance represents an unprecedented collaboration Framework that has the goal of running studies and answering drug safety questions with the use of extracted data from multiple European privately and publicly owned Electronic Healthcare Records (HER) databases. Such studies are performed in a collaborative and federated manner at the request of the EU-ADR Alliance Members and/or external organisations, generally in those cases where the participation of more than one database is required. The EU-ADR Alliance is also be devoted to the maintenance and continuing improvement of the EU-ADR system.

Despite the focus on drug safety studies, other kind of studies can be tackled by means of the Alliance, such as support to policy making (i.e. generating indicators that can then be of use to policymakers in their regulatory work).

The EU-ADR Alliance is composed by Members bringing in relevant expertise (EHR databases, information technologies (IT)). It is based on the concepts of:

• Federated databases
• Non-competition with its Members
• Independence and scientific interest.

The EU-ADR Alliance undertakes commissioned or Members individual studies and the annual Alliance Research Plan.

EU-ADR Alliance candidate Member organisations include eight European EHR databases with access to +45 million patients from Italy, Netherlands, UK, Germany and Denmark.

Background

The EU-ADR Alliance builds on the results of the EU-ADR project “Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records and Biomedical Knowledge” (funded by the ICT Unit of the European Commission in the 7th Framework Programme (7FP)), which has been a breakthrough in the use of technology to improve pharmacovigilance in federated studies.

Several FP7 drug safety studies have successfully implemented the approach and tools developed EU-ADR:
SOS, on the safety of non-steroidal anti-inflammatory drugs
ARITMO, studying the arrhythmogenic potential of drugs
SAFEGUARD, on the safety evaluation of adverse reactions in diabetes

The advantage of running studies through the Alliance is that more powerful studies can be set up and run faster, given that a governance structure and working methods are in place.

Between December 2011 and January 2012, several EU-ADR Alliance Members have started three projects awarded by the European Medicines Agency (EMA). Awarded in the context of a restricted invitation to tender sent to a number of candidates across Europe.

The first of the awarded projects evaluates patterns and determinants of use of oral contraceptives; another project monitors the effectiveness of risk minimisation in patients treated with pioglitazone-containing products; while the third one is a drug safety study exploring an association between cardiac valve disorders and the use of bisphosphonates.

Our Principles

The EU-ADR Alliance is an open and flexible federation of organisations with relevant expertise (EHR databases, information technologies, epidemiological research, text mining, statistical methodologies, omics), based on the following principles:

  • Federated databases
  • Autonomy
  • Scientific independence
  • Professionally managed by an Honest Broker (compliance with timelines, costs, quality, scope)
  • Study-centric approach
  • Extensive collaboration track record, including liaison with regulatory authorities, pharma, PPPs

The EU-ADR Alliance: a federated collaborative framework for drug safety studies

OUR MEMBERS

The EU-ADR Alliance is devised as a collaboration framework for running studies and answering drug safety questions in a federated manner, using extracted data from multiple European EHR and healthcare databases. The EU-ADR Alliance is composed of members bringing in relevant expertise (EHR databases, information technologies, epidemiological research). It is based on the concept of federated databases, non-competition with its members, independence and scientific interest. The EU-ADR Alliance provides an unprecedented framework to set up and run more powerful studies faster, by virtue of a governance structure and operating methods already in place. The table offers an overview of the databases available and their high-level characteristics. For more details please visit Database Profiles.

DATABASES

For more info click on the Organisation name

Key Researchers

  • Katia Verhamme
  • Johan van der Lei
  • Peter Rijnbeek

IPCI Database, The Netherlands

Erasmus University Medical Center (EMC)

Medical Informatics at EMC is an interdisciplinary research group, studying new methods for acquiring, representing, processing, and managing knowledge and data within healthcare and the biomedical sciences. Its research clusters around two main themes: structuring of medical data, with the electronic patient record as an important application area, and structuring of medical knowledge. An important focus is to link data from various sources for observational studies regarding drug safety. EMC is coordinator of the EU-ADR project and the drug safety projects SOS (Safety of NSAIDs), ARITMO (Arrythmogenic Potential of Drugs), SAFEGUARD (Evaluation of Adverse reactions in Diabetes), and VAESCO (Vaccine Adverse Event Surveillance & Communication). EMC also coordinates EMIF (European Medical Information Framework), a public-private partnership to create a medical information infrastructure.

Database Summary

The IPCI (Integrated Primary Care Information) database is located at the Erasmus MC Rotterdam in The Netherlands and is operated by the department of Medical Informatics in close collaboration with the Unit of Pharmaco-epidemiology at EMC.

The database is a longitudinal collection of electronic patient’s records from Dutch GPs into a central research database. The IPCI project was started in 1989 and has been proven suitable for the conduct of descriptive and analytic research with respect to:

• Incidence and prevalence of disease;
• Natural history of disease;
• Determinants of disease;
• Drug utilization by indication;
• Monitoring of new prescription drugs;
• Safety and effectiveness of prescription drugs;
• Application guidelines in daily practice;
• Clinical decision analysis.

Key Researchers

  • Lars Pedersen

Aarhus Regional Database, Denmark

Aarhus University Hospital, Department of Clinical Epidemiology (AUH -DCE)

The Department of Clinical Epidemiology (DCE) at Aarhus University Hospital was established in 2000 as a collaboration between two Danish counties and Aarhus University. The department is part of the Clinical Institute at Aarhus University and has two research sections in Aarhus and Aalborg. DCE deals with a great variety of clinical epidemiological topics and has approximately 50 employees. It is a department where clinical experience, biological knowledge, advanced biostatistics, laboratory research, medical informatics and computer technology are integrated. The department is continuously looking to optimize diagnostics and treatment of diseases and to prevent recurrence and complications through research and education. DCE has participated or participates in the EU-funded projects: EU-ADR, Arrythmogenic Potential of Drugs (ARITMO), Safety Evaluation of Adverse reactions in Diabetes (SAFEGUARD) and European Medical Information Framework (EMIF) projects.

Database Summary

Aarhus University Prescription Database collects data on reimbursed medications dispensed at all community pharmacies of the North and Central Denmark Regions. The regions have a combined population of 1.8 million inhabitants, or one-third of the Danish population. Denmark’s primary health care sector, which includes general practitioners, specialists, and dentists, generates about 96% of the prescription sales, most of which are reimbursable and are dispensed by the community pharmacies. The Aarhus University Prescription Database combines the region’s pharmacy records in a single database, maintained and updated for research purposes. Each dispensation record contains patient-, drug-, and prescriber-related data. Dispensation records retain patients’ universal personal identifier, which allows for individual-level linkage to all Danish registries and medical databases. The linked data have many applications in clinical epidemiology, including drug utilization studies, safety monitoring, etiologic research, and validation studies.

Key Researchers

  • Daniel Prieto-Alhambra
  • Bonaventura Bolíbar Ribas

SIDIAP Database, Spain

The University Institute in Primary Care Research Jordi Gol (IDIAP Jordi Gol)

The University Institute in Primary Care Research Jordi Gol (IDIAP Jordi Gol) was founded in 2006. It is a private, nonprofit making organization promoted by the Catalan Health Institute (CHI) and the Autonomous University of Barcelona, Spain. Since its inception IDIAP Jordi Gol has pioneered research in Primary Health Care in Spain.

The IDIAP aims to generate new knowledge and practical evidence to promote, advance and manage Primary Care research in Catalonia and other areas, by means of training, dissemination of results and translation of research findings into clinical practice. The IDIAP aims to lead research in Primary Health Care nationally and internationally, to become a centre of excellence that facilitates the participation of professionals and guarantees the dissemination and applicability of research into clinical practice.

Primary Care is organized in Catalonia (North-East Spain) in Primary Care Practices (PCPs) made up of a variable number of general practitioners, nurses, pediatricians, social workers, dentists and administrative staff. Each citizen resident in Catalonia has a general practitioner (GP) and a nurse assigned to them in one of these PCPs. Healthcare is universally provided, and in one year 70% of the population is attended at least once by their PCP. This increases to about 85% every three-year period. The CHI is the lead provider of primary care medical services in Catalonia; it manages, among others, 279 PCPs with 5.8 million citizens assigned to them – about 80% of the population of Catalonia.

The more than 10,000 Primary Care professionals of the CHI use the same electronic medical records software, named E-CAP. Implementation of this software started in 1998 in some PCPs, and since 2005 its use is generalized in all visits in all the PCPs of the CHI.

Database Summary

The Information System for the Development of Research in Primary Care (SIDIAP database) was created in 2010 as a joint venture set up by the CHI and the Primary Care Research Institute Jordi Gol (PCRI). Its main aim is to promote the development of research based on data from primary care electronic medical records and other complementary databases.
Currently the SIDIAP database stores clinical information obtained from 274 Primary Care Practices in Catalonia (equivalent to >3,000 GPs), with a total population of 5,835,000 patients (>80% of the Catalan population). Research-usable information is available for the period 2006-2012, making a total of >35 million person-years of data.
In brief, the information gathered in SIDIAP accounts for clinical and referral events, socio-demographics, lifestyle risk factors and other relevant variables (eg blood pressure, body mass index, smoking, alcohol drinking), socio-economic status (MEDEA ecologic index), primary care laboratory test results, and pharmacy invoice data. In addition, SIDIAP is fully linked to the official hospital inpatient database for Catalonia (CMBD-AH), as well as to some disease and procedure-specific registries (eg the Catalan Arthroplasty Registry).

Key Researchers

  • Dr. Francesco Lapi

Health Search Database (HSD), Italy

S.I.M.G. (Società Italiana di Medicina Generale)

S.I.M.G. (Società Italiana di Medicina Generale) is the Italian College of General Practitioners. Its aim is to promote the development of knowledge in the field of medical education and medical research, particularly for the following issues: (1) diagnosis, prevention and care of communicable and non-communicable diseases; (2) health service research and organization; (3) appropriateness of drug use and drug safety. Research is mainly developed throughout the Health Search Database (HSD), managed and coordinated by Genomedics Srl.

Database Summary

The Health Search/Longitudinal Patients Database (HSD) is a longitudinal observational database that is representative of the General Italian population. It was established in 1998 by the Italian College of General Practitioners. The HSD contains data from computer-based patient records from a select group of GPs [covering a total of 1 million active patients; 2.5 million of total patients (i.e. those died or transferred out); 18 million of person-years] located throughout Italy who voluntarily agreed to collect data for the database and attend specified training courses. Turnover occurs as patients move and transfer to new practices. The records of ‘transferred out’ patients remain in the database and are available for retrospective studies with the appropriate time periods. The HSD complies with European Union, guidelines on the use of medical data for research. The HSD has been the data source for a number of peer-reviewed publications on the prevalence of disease conditions, drug safety and prescription patterns in Italian primary care. Approval for use of data is obtained from the Italian College of Primary Care Physicians. Data are in house, no ethical approval needed. The HSD is fully compliant with EU guidelines on the use of medical data for medical research, it relies on anonymised data (European guidelines allow the use of anonymised data for research). The database is updated continuously, every 6 months a data draw down is made for research purposes.

Key Researchers

  • Dr. Luigi Cantarutti
  • Carlo Giaquinto MD

PEDIANET Paediatric Database, Italy

Società Servizi Telematici (PEDIANET)

Società Servizi Telematici is an SME, which uses the acronym PEDIANET. PEDIANET was established in 1998 and it is the first European network of family-paediatricians and has been part of a number of EU funded projects including: TEDDY, EU-ADR, SOS, GRIP and EMIF.

Database Summary

The PEDIANET Paediatric Database was established in Italy in 1998 to collect epidemiological information for clinical research from family paediatricians. The system is based on the transmission of specific data including reason of access, diagnosis, prescriptions, clinical data and outcomes from computerized clinical files, which the paediatricians in the network fill out during their daily professional activities. Data sent to the central server also include text fields which are very useful for data validation. Recently Pedianet has developed the possibility of linking individual patient information with hospitalization and vaccination databases. This opportunity represents a unique tool for conducting pharmacovigilance studies. Informed consent is acquired from the parents. Such data is collected anonymously by a central server in Padova, where it is validated and elaborated. The database is owned by a SME called Società Servizi Telematici.

Key People

  • Carlos Díaz
  • Eva Molero
  • Natasha Yefimenko

Synapse Research Management Partners

EU-ADR Alliance honest broker and management office

Synapse is a company specialized in the management of research projects in the biomedical sector, working with a great variety of stakeholders at both national and international levels (pharmaceutical and biotechnology companies, research centres, academia, hospitals, etc.). Synapse’s partners are typically visionary, creative researchers able to attract and lead large and ambitious research projects in the biomedical domain, for which they need professional and specialized managerial support at all levels.

Synapse focuses on complex research projects that are highly innovative, ambitious, and distributed (based on collaboration of teams scattered in different institutions and countries), with a specific focus on European and IMI projects, pharmaceutical research (from pre-clinical to post-marketing) and IT development.

Synapse services aim to provide integral support to the scientific coordination throughout the project life cycle, and include strategic planning and scoping of the project, configuration and development of work plans (full Work Breakdown Structure definition, including milestones and deliverables, dependencies and risk management), development of governance mechanisms, design and implementation of management tools, budget elaboration and financial monitoring, knowledge management, legal management, design and deployment of a dissemination/communication strategies, and advanced exploitation/sustainability strategies for research endeavours and results. Furthermore, Synapse has extensive experience in the design and organization of training activities. The company acts as exploitation, IPR and sustainability leader or key player in many recent/ongoing projects (e.g., FP7 HEALTH projects GEN2PHEN, SAFEGUARD, ARITMO; IMI projects eTOX, OpenPhacts, EMIF and ADVANCE; ICT projects INBIOMEDvision and EU-ADR; etc.).

Synapse is currently involved in the IMI JU Knowledge Management group aiming at facilitating the knowledge exchange and collaboration among funded projects in pursue of optimal utilisation of generated results.

Synapse leverages the expertise of highly skilled, experienced project management professionals with a track record of over 15 years in international collaborative research projects, with special attention to EC-funded projects since FP3 (including ESPRIT, INCO, TAP, LIFE, IST, ICT, HEALTH, ENVIRONMENT, NMP, IMI JU) among other programmes and funding schemes, acting e.g. as Coordinators of the Programme Management Office of the IMI JU funding for EMIF, a large-scale (48 M€) IMI project.

Synapse also acts as consultant in project management for a variety of national and international organisations, and undertakes private projects for the pharmaceutical industry, acting as honest broker and management office for the EU-ADR Alliance and participating in several vaccine and drug research and development projects.

RESEARCH SERVICES

EU-ADR Alliance provides deep expertise and high standards in

setting up and coordinating multi-country database studies:

Post-Authorisation Safety Study (PASS) Effectiveness of Risk management
Observational Studies Drug Utilization Studies (DUS)

FAQs

Frequently Asked Questions

I want to undertake a study. How do I start the process with EU-ADR Alliance?

The first step is to contact a member of the EU-ADR Alliance with a brief study concept. The first point of contact during the early stages of planning a study is usually Synapse Research Management Partners, as this partner holds the role of “honest broker”. However, if you already know, or have worked with other partners in the Alliance, do not hesitate to make the first contact through that organization.

What is the EU-ADR Alliance procedure for choosing studies?

The Alliance partner that you first approached with the study concept will then share the information with the whole EU-ADR Alliance network. Any database may chose to participate or not in any study.
Once the partners confirm their interest in the study area, the most suitable Scientific Coordinator is agreed by all the partners involved. This will usually be the partner with the most experience in the field of that specific study.

From first point of contact, how soon can the EU-ADR Alliance start a new study?

This primarily depends on the study requester (sponsor). Once the EU-ADR Alliance partners decide that they are interested in undertaking a study, and the study concept is agreed upon with the sponsor, a contract can be drawn up. Once the contract is signed, a study can start.

My study may require European Medicines Agency approval (EMA); how might this impact the study timeframe?

It can take 4 to 6 months to design a study protocol and get it fully approved by EMA. EU-ADR Alliance experience has shown that the preparation of the protocol for submission to EMA usually takes around 2 to 3 months, depending on the time of year. EMA then may take a further 2 months to carry out the review and request changes, or even reject a study.

Can you compare the data across the Alliance countries?

In general yes, there are examples of some countries with a stable relationship between the patient and the GP.

What is the process for data gathering and amalgamation?

Studies are selected by Alliance partners based on interest and whether they feel their data are suitable for purpose. The Alliance partners then work on developing a common protocol. After this the databases do the coding, and then a software data structure (Jerboa) takes the results.

When you have multiple databases involved how can you ensure that Alliance partners understand what has been done with the data and then control quality?

These issues are checked by benchmarking to see if all are partners understood correctly. Within Jerboa, the data sources provide information but analysis is carried out by Jerboa itself.

LIST OF PUBLICATIONS

2017

Katia MC Verhamme, Marjolein Engelkes, Maria de Ridder, Elisabeth Svensson, K. Klara Berencsi, Daniel Prieto-Alhambra, Francesco Lapi, Carlo Giaquinto, Gino Picelli, Nada Boudiaf, Frank Albers, Sarah M. Cockle, Eric Bradford, Melissa K. Van Dyke, Esmé Baan Peter Rijnbeek, Guy Brusselle, Miriam Sturkenboom (2017) Characteristics of adult onset vs. late onset asthma – a multinational database cohort study. Poster presentation at ERS 2017

M Sanni Ali, Klara Berencsi, Karine Marinier, Nicolas Deltour, Samuel Hawley, Lars Pedersen, Peter Rijnbeek, R.G. Duijnhoven, Johan Van der Lei, Francesco Lapi, Monica Simonetti, Cristina Reyes-Reyes, Miriam Sturkenboom, and Daniel Prieto-Alhambra (2017) Comparative cardiovascular safety of strontium ranelate and bisphosphonates amongst patients with no contraindications: a multi-database study in four European countries by the EU-ADR Alliance. Poster presentation at ISPE 2017

Klara Berencsi, M Sanni Ali, Karine Marinier, Nicolas Deltour, Samuel Hawley, Lars Pedersen, Peter Rijnbeek, R.G. Duijnhoven, Johan Van der Lei, Francesco Lapi, Monica Simonetti, Cristina Reyes-Reyes, Miriam Sturkenboom, and Daniel Prieto-Alhambra. Impact of risk minimisation measures on the use of strontium ranelate: a multi-national cohort study in 5 EU countries by the EU-ADR Alliance. Oral presentation at ISPE 2017

2016

Klara Berencsi, Cristina Reyes Reyes, Lars Pedersen, Preciosa Coloma, Francesco Lapi, Monica Simonetti, Peter Rijnbeek, Miriam C Sturkenboom and Daniel Prieto-Alhambra (2016). The impact of risk minimisation measures on the incidence and prevalence of use of strontium ranelate at the population level: preliminary results of a multi-national cohort study including 5 European countries. ICPE 2016

Marjolein Engelkes, Maria de Ridder, Elisabeth Svensson, Klara Berencsi, Daniel Prieto-Alhambra, Francesco Lapi, Carlo Giaquinto, Gino Picelli, Nada Boudiaf, Frank Albers, Sarah Cockle, Eric Bradford, Robert Suruki, Hana Mullerova, Peter Rijnbeek, Miriam Sturkenboom, Katia Verhamme. Multinational, database cohort study to study mortality in patients with severe asthma. ERS 2016

Marjolein Engelkes, Maria de Ridder, Elisabeth Svensson, Klara Berencsi, Dani Prieto, Francesco Lapi, Carlo Giaquinto, Gino Picelli, Nada Boudiaf, Frank Albers, Sarah Cockle, Eric Bradford, Robert Suruki, Peter Rijnbeek, Miriam Sturkenboom, Katia Verhamme (2015) Multinational, multi-database asthma cohort study to assess the incidence rate of severe asthma exacerbations. ERS 2016

Katia MC Verhamme, Maria De Ridder, Lars Pedersen, Daniel Prieto-Alhambra, Francesco Lapi, Peter Rijnbeek, Rajeev K Amar (2016). Patient characteristics of new initiators of glycopyrronium bromide (GLY) – a multinational, multi-database real-world drug-utilization study. ERS 2016

2015

Marjolein Engelkes, Maria de Ridder, Elisabeth Svensson, Klara Berencsi, Daniel Prieto-Alhambra, Francesco Lapi, Carlo Giaquinto, Gino Picelli, Nada Boudiaf, Frank Albers, Sarah Cockle, Eric Bradford, Robert Suruki, Peter Rijnbeek, Miriam Sturkenboom, Katia Verhamme (2015) Multinational, database cohort study to assess severe asthma exacerbation rate in patients with asthma. ERS 2015

Marjolein Engelkes, Maria de Ridder, Elisabeth Svensson, Klara Berencsi, Daniel Prieto-Alhambra, Francesco Lapi, Carlo Giaquinto, Gino Picelli, Nada Boudiaf, Frank Albers, Sarah Cockle, Eric Bradford, Robert Suruki, Peter Rijnbeek, Miriam Sturkenboom, Katia Verhamme (2015). Multinational, database cohort study to assess all-cause mortality following severe asthma exacerbations. ERS 2015

Articles

P. M. Coloma & M. de Ridder & I. Bezemer & R. M. C. Herings & R. Gini & S. Pecchioli & L. Scotti & P. Rijnbeek & M. Mosseveld & J. van der Lei & G. Trifirò & M. Sturkenboom & on behalf of the EU-ADR Consortium (2015) Risk of cardiac valvulopathy with use of bisphosphonates: a population-based, multi-country case-control study. Osteoporos Int Pubmed

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