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
Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of pertussis and pertussis related outcomes of whole-cell pertussis and acellular pertussis vaccines in pre-school children European Commission Aarhus U., ARS Toscana, IDIAPJGol 2013
Evaluation of potential off-label use of dabigatran etexilate in Europe Boehringer Ingelheim GmbH RTI-HS, SDU 2013
Evaluation of the Use of Nepafenac in Selected European Populations Alcon Labs, Inc. RTI-HS, PHARMO, SDU 2013
Safety Evaluation of Adverse Reactions in Diabetes - Drug utilisation studies European Commission BIPS, PHARMO, RTI-HS 2013
Risk of Skin Cancer and Lymphoma in Users of Topical Tacrolimus, Pimecrolimus, and Corticosteroids Astellas Pharma Europe B.V. RTI-HS, PHARMO, SDU 2013
Cilostazol Drug Utilisation Study Otsuka Pharmaceutical Europe, Ltd. RTI-HS, BIPS, IDIAPJGol 2013
Safety Evaluation of Adverse Reactions in Diabetes - Comparative studies European Commission BIPS, PHARMO, RTI-HS 2011
Patterns and Determinants of Use of Oral Contraceptives in the European Union European Medicines Agency (EMA) ARS Toscana, PHARMO 2011
CAncer Risk and INsulin analoGues (CARING) European Commission Utrecht U., Aarhus U. 2011
Study of Acute Liver Transplant: A study of NSAIDs-exposed acute liver failure in European transplant centres Helsinn Healthcare S.A. BPE, RTI-HS 2008