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
Cohort monitoring of Adverse Events of Special Interest and COVID-19 diagnoses prior to and after COVID-19 vaccination European Medicines Agency (EMA) UMCU, ARS Toscana, PHARMO, Utrecht U. 2020

Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine
Pfizer RTI-HS, UMCU, ARS Toscana, IDIAPJGol, PHARMO 2020
Pregnancy outcomes in women exposed to oral cladribine: a multi-country cohort database study Merck Healthcare KGaA RTI-HS, Dundee U. 2019
A Retrospective Cohort Study to Assess Drug Utilisation and Long-Term Safety of Galcanezumab in European Patients in the Course of Routine Clinical Care Eli Lilly and Company PHARMO, ARS Toscana, BIPS, BPE, IDIAPJGol 2019
Adherence, persistence and switching patterns – once- and twice-daily direct oral anticoagulants Daiichi Sankyo Europe GmbH PHARMO, ARS Toscana, BIPS 2019
Impact of EU label changes and pregnancy prevention programme for medicinal products containing valproate and related substances: risk awareness and adherence European Medicines Agency (EMA) Utrecht U., UMCU, ARS Toscana, PHARMO 2019
Impact of EU label changes and revised pregnancy prevention programme for oral retinoid containing medicinal products: utilization and prescribing trends European Medicines Agency (EMA) UMCU, ARS Toscana, BPE, IDIAPJGol, PHARMO 2019
Drug utilisation study of Radium 223 under routine clinical practice in Europe Bayer AG RTI-HS, Aarhus U., BIPS 2019
The BRodalumab Assessment of Hazards: A Multinational Safety (BRAHMS) study in electronic healthcare databases LEO Pharma SDU, ARS Toscana, BIPS, PHARMO 2018
Impact of EU label changes for hydroxyzine products: post-referral prescribing trends European Medicines Agency (EMA) Dundee U., PHARMO, SDU 2018
Multisource Surveillance Study of Pregnancy and Infant Outcomes in Ocrelizumab-Exposed Women With Multiple Sclerosis Roche RTI-HS, Aarhus U. 2017
Impact of EU label changes for systemic diclofenac products: post-referral prescribing trends European Medicines Agency (EMA) Dundee U., PHARMO, SDU 2017