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 SIGMA data table.

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, propensity score-based approaches to confounding control, and other advanced methods in pharmacoepidemiology.
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.

SIGMA Collaboration approaches

At SIGMA, we are committed to advancing epidemiological research through the most effective collaboration approaches. We offer two distinct strategies to facilitate data analysis and interpretation:

Local programming and analyses

Each participating site conducts the data analysis using local programming, adhering to the common protocol and statistical analysis plan. The individual results from each site are then pooled together to generate overall results. This method leverages the unique expertise and resources of each site, ensuring that the analysis is tailored to local contexts while contributing to a broader understanding of the research question.

Central programming and analyses

Data from all participating sites are standardized into a common data model. Centralized programming and analysis are then conducted on this harmonized dataset, based on the common protocol and statistical analysis plan. This strategy ensures consistency and comparability across sites, enabling robust and scalable analyses.

European collaborations

Title & Link to HMA-EMA Catalogue of RWD studies	Funding entity	Participating SIGMA Members	Start Year
Postauthorisation Safety Study (PASS) of Avatrombopag and Haematological Malignancies in Patients With Primary Immune Thrombocytopaenia	Swedish Orphan Biovitrum AB (publ)	RTI-HS, Aarhus U., KI	2024
SAFETY-VAC: Background incidence estimation of flares of pre-existing chronic diseases using pan-European electronic healthcare data sources	European Medicines Agency (EMA)	UMCU, Aarhus U., ARS Toscana, BPE, FISABIO, IDIAPJGol, Utrecht U.	2024
The utilisation of antiepileptics in men and women of childbearing age, and pregnant women in Europe (ADEPT)	European Medicines Agency (EMA)	Utrecht U., ARS Toscana, FISABIO, IDIAPJGol, PHARMO, UMCU	2024
SAFETY-VAC: Network of Data Sources for Vaccine Safety Evaluation	European Medicines Agency (EMA)	UMCU, Aarhus U., ARS Toscana, BPE, FISABIO, IDIAPJGol, Utrecht U.	2024
Post-authorisation Safety Study of Rimegepant in Patients with Migraine and History of Cardiovascular Disease in European Countries	Pfizer	RTI-HS, IDIAPJGol, PHARMO	2023
A Drug Utilization Study to Evaluate the Effectiveness of Risk Minimization Measures (RMMs) for Abrocitinib in the EU Using Electronic Healthcare Data	Pfizer	Aarhus U., BPE, IDIAPJGol, KI	2022
An Active Surveillance Study to Monitor the Safety of Abrocitinib Among Real-World Patients with Atopic Dermatitis (AD) in the European Union (EU)	Pfizer	Aarhus U., BPE, KI	2022
Long-term real-world safety of ozanimod – A post-authorisation safety study (PASS) in patients diagnosed with ulcerative colitis	Bristol-Myers Squibb (BMS)	BPE, BIPS, Dundee U., NIPH, PHARMO, RTI-HS, SDU	2022
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., FISABIO, IDIAPJGol	2022
Safety of Paxlovid Among Patients with Moderate or Severe Hepatic or Renal Impairment	Pfizer	RTI-HS, ARS Toscana, BPE, IDIAPJGol, UMCU	2022