Collaborative experience

Members of the SIGMA Consortium have extensive experience in collaborating in several multi-country studies under the principles of the European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP). All members are dedicated to excellence in research by adhering to the ENCePP Guide on Methodological Standards and promoting scientific independence and transparency. Past and current examples of collaborative experience are highlighted below. All studies are registered in the EU PAS register, a publicly accessible resource for the registration of pharmacoepidemiological and pharmacovigilance studies (See Table ‘European Collaborations‘).

Each SIGMA member has access to different data, as summarized in the Table below.

The SIGMA consortium was presented virtually at ISPE’s 37th International Conference on Pharmacoepidemiology and Therapeutic Risk Management (ICPE 2021 All Access) held August 23-25 2021.

ICPE poster

Members of the SIGMA Consortium have extensive research experience and protocol-based access to data sources for the conduct of RWE/pharmacoepidemiology studies

Name of database
Country
ARS Toscana Italy
Danish Health
Registers
Denmark
GePaRD
Germany
SNDS
France
SIDIAP
Spain
PHARMO Database
Network
Netherlands
Scottish Prescribing
Information System
UK
Name of database Country
Type
ARS Toscana Italy
Claims
Danish Health Registers Denmark
Linked registers for dispensed prescriptions, laboratory values, hospitalizations, and mortality
GePaRD Germany
Claims from 4 SHI providers
SNDS France
Claims
SIDIAP Spain
Primary health care electronic medical records + partial linkage to other data
PHARMO Database Network Netherlands
Primary health care electronic medical records + partial linkage to other data
Scottish Prescribing Information System UK
Prescriptions linked to diagnoses
Name of database Country
Size (% coverage)
ARS Toscana Italy
3.6 million
(100% Tuscany)
Danish Health Registers Denmark
5.8 million
(100% Denmark)
GePaRD Germany
17.5 million
(21% Germany)
SNDS France
66 million
(99% France)
SIDIAP Spain
5.6 million
(73% Catalonia)
PHARMO Database Network Netherlands
4 million
(23% Netherlands)
Scottish Prescribing Information System UK
5.4 million
(100% Scotland)
Name of database Country
Prescription/dispensings data
ARS Toscana Italy
Danish Health Registers Denmark
GePaRD Germany
SNDS France
SIDIAP Spain
PHARMO Database Network Netherlands
Scottish Prescribing Information System UK
Name of database Country
Hospital data
ARS Toscana Italy
Danish Health Registers Denmark
GePaRD Germany
SNDS France
SIDIAP Spain
PHARMO Database Network Netherlands
Scottish Prescribing Information System UK
Name of database Country
Primary care data
ARS Toscana Italy
Danish Health Registers Denmark
GePaRD Germany
SNDS France
SIDIAP Spain
PHARMO Database Network Netherlands
Scottish Prescribing Information System UK
Name of database Country
Laboratory data
ARS Toscana Italy
Danish Health Registers Denmark
GePaRD Germany
SNDS France
SIDIAP Spain
PHARMO Database Network Netherlands
Scottish Prescribing Information System UK
Name of database Country
Cancer data
ARS Toscana Italy
Danish Health Registers Denmark
GePaRD Germany
SNDS France
SIDIAP Spain
PHARMO Database Network Netherlands
Scottish Prescribing Information System UK
Name of database Country
Pregnancy data
ARS Toscana Italy
Danish Health Registers Denmark
GePaRD Germany
SNDS France
SIDIAP Spain
PHARMO Database Network Netherlands
Scottish Prescribing Information System UK
Name of database Country
Emergency data
ARS Toscana Italy
Danish Health Registers Denmark
GePaRD Germany
SNDS France
SIDIAP Spain
PHARMO Database Network Netherlands
Scottish Prescribing Information System UK
ARS = Agenzia regionale di sanità della Toscana; EMR = Electronic medical records; GePaRD = German Pharmacoepidemiological Research Database; SNDS = French National Healthcare System database; SIDIAP = Sistema d'Informació per al Desenvolupament de la Investigació en Atenció Primaria

SIGMA Members Utrecht University and RTI Health Solutions also have the ability to access and work with data from the Clinical Practice Research Datalink (CPRD) in the UK

European collaborations

Full Title & EUPAS Link Funding entity Coord. Center Other Participating SIGMA Members Start Year
Malignancies in Multiple Sclerosis: multi-country cohort database studies (feasibility study) Merck KGaA BPE, Aarhus U., PHARMO 2017
Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus, Pimecrolimus, and Corticosteroids LEO Pharma A/S RTI-HS, PHARMO, SDU 2017
Intravenous Iron Postauthorisation Safety Study (PASS): Evaluation of the Risk of Severe Hypersensitivity Reactions IV Iron Marketing Authorisation Holders Consortium RTI-HS, Aarhus U., BIPS, PHARMO 2017
Cohort Study of the Incidence of Major Cardiovascular Events in New Adult Users of Lisdexamfetamine and Remote Adult Users of Other ADHD Treatments Shire Human Genetic Therapies, Inc. RTI-HS, Aarhus U. 2017
Non-interventional post-authorization multi-database safety study to assess the risk of myotoxicity, hepatotoxicity and acute pancreatitis in statin-exposed heart failure patients with or without concomitant use of sacubitril/valsartan (Entresto®) Novartis Pharma AG PHARMO, Aarhus U., ARS Toscana, BIPS, IDIAPJGol 2017
Non-interventional post-authorization multi-database safety study to characterize the risk of angioedema and other specific safety events of interest in association with use of Entresto® (sacubitril/valsartan) in adult patients with heart failure Novartis Pharma AG PHARMO, Aarhus U., ARS Toscana, BIPS, IDIAPJGol 2017
Post-authorization Safety Study Evaluation of Cardiovascular Events in Users of Mirabegron and Other Treatments for Overactive Bladder Astellas Pharma Global Development, Inc. RTI-HS, SDU 2016
Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU European Medicines Agency (EMA) UMCU, BPE 2016
Drug utilization study of mirabegron (Betmiga®) using real-world healthcare databases from the Netherlands, Spain, United Kingdom and Finland Astellas PHARMO, IDIAPJGol 2016
Post-authorisation safety study in patients with type 2 diabetes mellitus to assess the risk of acute liver injury, acute kidney injury and chronic kidney disease, severe complications of urinary tract infection, genital infections, and diabetic ketoacidosis among patients treated with empagliflozin compared to patients treated with DPP-4 inhibitors Boehringer Ingelheim International GmbH RTI-HS, Aarhus U. 2016
An Observational Post-Authorisation Safety Study of Lesinurad Patients Astra Zeneca RTI-HS, IDIAPJGol 2016
Cohort study of cardiovascular events in patients with chronic obstructive pulmonary disease initiating olodaterol or other long-acting beta2-agonists Boehringer Ingelheim International GmbH RTI-HS, Aarhus U. 2015