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

Effectiveness of heterologous and booster Covid-19 vaccination in 5 European countries, using a cohort approach in children and adults with a full primary Covid-19 vaccination regimen
European Medicines Agency (EMA) ARS Toscana, IDIAPJGol, PHARMO, RTI-HS, UMCU, Utrecht U. 2022

An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using European Healthcare Data through VAC4EU (COVID-19)
Janssen UMCU, ARS Toscana, IDIAPJGol, PHARMO 2022

Post-Authorization Active Surveillance Safety Study Using Secondary Data to Monitor Real-World Safety of Spikevax in Europe (COVID-19)
Moderna Aarhus U., ARS Toscana, IDIAPJGol 2021

A post-authorisation/post-marketing observational study to evaluate the association between exposure to AZD1222 and safety concerns using existing secondary health data sources (COVID-19)
AstraZeneca AB RTI-HS, ARS Toscana, IDIAPJGol, PHARMO, UMCU 2021
Renin-angiotensin-aldosterone system inhibitors and adverse outcomes of COVID-19: a Danish nationwide cohort study Aarhus University Aarhus U., SDU 2020
First-line anticancer drugs in patients with advanced, primary Non-Small Cell Lung Cancer: drug-utilization and effectiveness studies from Tuscany Region healthcare database N/A BPE, ARS Toscana 2020
Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines European Medicines Agency (EMA) UMCU, Aarhus U., ARS Toscana, BIPS, BPE, IDIAPJGol, PHARMO, RTI-HS, Utrecht U. 2020
Drug-drug interactions between dicloxacillin/flucloxacillin and DOACs N/A SDU, Utrecht U. 2020
Strengthening Use of Real-World Data in Medicines Development: Metadata for Data Discoverability and Study Replicability European Medicines Agency (EMA) RTI-HS, Aarhus U., ARS Toscana, BIPS, BPE, PHARMO, UMCU, Utrecht U. 2020
CONSIGN study: COVID-19 infection and medicines in pregnancy - a multinational registry based study European Medicines Agency (EMA) Aarhus U., ARS Toscana, BIPS, BPE, RTI-HS, UMCU, Utrecht U. 2020
Data source heterogeneity in multi-database pharmacoepidemiologic studies: a scoping review (DIVERSE) International Society for Pharmacoepidemiology (ISPE) Utrecht U., ARS Toscana 2020
Description of international collaboration in the area of medicines use and effects in COVID-19 affected pregnancies (CONSIGN-International)) European Medicines Agency (EMA) UMCU, Aarhus U., ARS Toscana, BIPS, BPE, RTI-HS, Utrecht U. 2020