Collaborative experience

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 Coord. Center Participating SIGMA Members Start Year

Safety of Paxlovid During Pregnancy
Pfizer RTI-HS, ARS Toscana, BPE, IDIAPJGol, UMCU 2022
FINErenone druG Utilization Study and assessment of Temporal changes following availability of different treatment options in patients with chronic kidney disease and type 2 diabetes (FINEGUST)
Bayer AG RTI-HS, Aarhus U., PHARMO, FISABIO 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 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

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

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., 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, FISABIO, IDIAPJGol, PHARMO, UMCU 2021

Rapid Safety Assessment of SARS-CoV-2 vaccines in EU Member States using electronic health care datasources (CVM Covid19-Vaccine-Monitor-EHR)
European Medicines Agency (EMA) UMCU, FISABIO, IDIAPJGol, PHARMO, RTI-HS, Utrecht U. 2021
Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines (ACCESS-BGR)
European Medicines Agency (EMA) UMCU, Aarhus U., ARS Toscana, BIPS, BPE, FISABIO, IDIAPJGol, PHARMO, RTI-HS, Utrecht U. 2020
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