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 HMA-EMA Catalogue of Real-World Data (RWD) Studies, 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

Methodological Approach

The SIGMA Consortium uses state-of-the-art methodology including causal inference target trial emulation methods. 
All studies are aligned with the ENCePP research guidance, ISPE good practice guidance, and GVP module VIII principles.
In order to allow efficient execution of programs against local data, a common data model (CDM) can be used in SIGMA studies. 
SIGMA Members and Collaborators have experience in mapping to various study-specific and non-study-specific CDMs, including the ConcePTION harmonisation pipeline, BRAHMS, OMOP, Sentinel, and TheShinISS.

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

Name of data source
Danish Health
Registers
Finnish Health
Registers
SNDS
GePaRD
ARS Toscana
Caserta Regional
Database
THIN
PHARMO Database
Network
Norwegian Health
and Administrative
Registers
SIDIAP
Swedish Health Registers
Scottish Prescribing
Information System
CPRD
Country
Denmark
Finland
France
Germany
Italy
Italy
Italy
Netherlands
Norway
Spain
Sweden
UK
UK
Institution
Aarhus University | SDU
University of Eastern Finland
Bordeaux
PharmacoEpi
BIPS GmbH
ARS Toscana
University of
Verona
UNIMIB
PHARMO Institute
NIPH
IDIAP JGol
Karolinska
Institute
University of
Dundee
RTI Health Solutions | Ultretch Univerity
Name of database Country
Type
Danish Health Registers
Linked registers for dispensed prescriptions, laboratory values, hospitalizations, and mortality
Finnish Health Registers
Linked national registers for dispensed prescriptions, hospitalisations and outpatient visits, laboratory values, mortality, causes of death​
SNDS
Claims
GePaRD
Claims from 4 SHI proveiders
ARS Toscana
Claims data
Caserta Regional Database
Claims
THIN
Primary health care electronic medical records
PHARMO Database Network
Primary health care electronic medical record + partial linkage to other dcata
Norwegian Health and Administrative Registers
Linked national registers for dispensed prescriptions, hospitalizations, specialist outpatient care, primary care, and causes of death
SIDIAP
Primary health care electronic medical records + partial linkage to other data
Swedish Health Registers
Linked national national refisters for dispensed prescriptions, hospitalizations, and mortality.
Scottish Prescribing Information System
Prescriptions linked to diagnoses
CPRD
Primary healt care electronic medical records + partial linkage to other data
Name of database Country
Size
Danish Health Registers
5.8 million
Finnish Health Registers
5.5 million
SNDS
66 million
GePaRD
17.5 million
ARS Toscana
3.6 million
Caserta Regional Database
1.2 million
THIN
1.7 million full db
/ 860.000 active
patients
PHARMO Database Network
4 million
Norwegian Health and Administrative Registers
5.5 million
SIDIAP
5.6 million
Swedish Health Registers
10.5 million
Scottish Prescribing Information System
5.4 million
CPRD
 Aurum: 13.3 million GOLD: 2.9 million of acceptable patients
Name of database Country
(% coverage)
Danish Health Registers
(100% Denmark)
Finnish Health Registers
(100% Finland)
SNDS
(99% France)
GePaRD
(21% Germany)
ARS Toscana
(100% Tuscany region)
Caserta Regional Database
(21% Campania region)
THIN
(1,5% Italy)
PHARMO Database Network
(23% Netherlands)
Norwegian Health and Administrative Registers
(100% Norway)
SIDIAP
(73% Catalonia)
Swedish Health Registers
(100% Sweden)
Scottish Prescribing Information System
(100% Scotland)
CPRD
(Aurum: 19.83 % UK, GOLD: 4.4% UK)
Name of database Country
Prescription/dispensings data
Danish Health Registers
Finnish Health Registers
SNDS
GePaRD
ARS Toscana
Caserta Regional Database
THIN

(prescription data)
PHARMO Database Network
Norwegian Health and Administrative Registers
SIDIAP
Swedish Health Registers
Scottish Prescribing Information System
CPRD
Name of database Country
Hospital data
Danish Health Registers
Finnish Health Registers
SNDS
GePaRD
ARS Toscana
Caserta Regional Database
THIN

(partial)
PHARMO Database Network
Norwegian Health and Administrative Registers
SIDIAP
Swedish Health Registers
Scottish Prescribing Information System
CPRD
Name of database Country
Primary care data
Danish Health Registers
Finnish Health Registers

(since 2011)
SNDS
GePaRD
ARS Toscana
Caserta Regional Database
THIN
PHARMO Database Network
Norwegian Health and Administrative Registers
SIDIAP
Swedish Health Registers
Scottish Prescribing Information System
CPRD
Name of database Country
Laboratory data
Danish Health Registers
Finnish Health Registers

(since 2014)
SNDS
GePaRD
ARS Toscana
Caserta Regional Database

(Lab test request available;
around 20% of the of the lab tests
results for
people residing in Caserta
are performed in
public healthcare structures
and can be traced)
THIN

(partial)
PHARMO Database Network
Norwegian Health and Administrative Registers

(Only positive tests fot notifiable infectious diseases)
SIDIAP
Swedish Health Registers
Scottish Prescribing Information System
CPRD
Name of database Country
Cancer data
Danish Health Registers
Finnish Health Registers
SNDS
GePaRD
ARS Toscana
Caserta Regional Database
THIN

(partial)
PHARMO Database Network
Norwegian Health and Administrative Registers
SIDIAP
Swedish Health Registers
Scottish Prescribing Information System
CPRD
Name of database Country
Pregnancy data
Danish Health Registers
Finnish Health Registers
SNDS
GePaRD
ARS Toscana
Caserta Regional Database

(pregnant persons can be identified through birth registry - 2018)
THIN

(partial)
PHARMO Database Network
Norwegian Health and Administrative Registers
SIDIAP
Swedish Health Registers
Scottish Prescribing Information System
CPRD
Name of database Country
Emergency data
Danish Health Registers
Finnish Health Registers

(limited)
SNDS
GePaRD
ARS Toscana
Caserta Regional Database

(limited)
THIN
PHARMO Database Network
Norwegian Health and Administrative Registers
SIDIAP
Swedish Health Registers
Scottish Prescribing Information System
CPRD
Most relevant publication
Most relevant publication
Danish Health Registers
Finnish Health Registers
Caserta Regional Database
THIN
PHARMO Database Network
Norwegian Health and Administrative Registers
SIDIAP
Scottish Prescribing Information System
ARS = Agenzia regionale di sanità; CPRD = Clinical Practice Research Datalink;  GePaRD = German Pharmacoepidemiological Research Database; NIPH = Norwegian Institute of Public Health; SDU = Southern Denmark University; SIDIAP = Sistema d'Informació per al Desenvolupament de la Investigació en Atenció Primaria; SNDS = French National Healthcare System database; THIN = The Health Improvement Network; UNIMIB = University of Milano Bicocca.

European collaborations

Full Title & EUPAS Link Funding entity Coord. Center Other Participating SIGMA Members Start Year
Post-authorisation Safety Study of Rimegepant in Patients with Migraine and History of Cardiovascular Disease in European Countries Pfizer RTI-HS, IDIAPJGol, PHARMO 2023

Drug Utilization Study Evaluating Additional Risk Minimisation Measures for Upadacitinib in the Treatment of Ulcerative Colitis in Europe
AbbVie KI, Aarhus U., RTI-HS 2022

Cohort Study of Long-term Safety of Upadacitinib for the Treatment of Ulcerative Colitis and Crohn’s Disease in a Real-world Setting in Europe
AbbVie KI, Aarhus U., RTI-HS 2022

Clinical course, outcomes and risk factors of myocarditis and pericarditis following administration of Moderna vaccines targeting SARS-CoV-2
Moderna Aarhus U., IDIAPJGol 2022

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, RTI-HS 2022

Post-authorisation Safety Study of Tralokinumab Use in Pregnancy: An Observational Study Based on Electronic Healthcare Data
LEO Pharma A/S RTI-HS, BIPS, BPE 2021

Cohort Study of Long-term Safety of Upadacitinib in the Treatment of Atopic Dermatitis in Denmark and Sweden
AbbVie KI, Aarhus U. 2021

Post-Authorisation Active Surveillance Study of Myocarditis and Pericarditis Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine
Pfizer UMCU, ARS Toscana, IDIAPJGol, PHARMO, RTI-HS 2021

Monitoring safety of Spikevax in pregnancy: an observational study using routinely collected health data in five European countries (COVID-19)
Moderna Aarhus U., ARS Toscana, IDIAPJGol 2021

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