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
ACCESS template protocol for safety of COVID-19 vaccines	European Medicines Agency (EMA)	UMCU, Aarhus U., ARS Toscana, BIPS, BPE, IDIAPJGol, PHARMO, RTI-HS, 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
Cohort monitoring of Adverse Events of Special Interest and COVID-19 diagnoses prior to and after COVID-19 vaccination (ECVM)	European Medicines Agency (EMA)	UMCU, ARS Toscana, PHARMO, Utrecht U.	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, FISABIO, KI, RTI-HS, 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
CONSIGN study: COVID-19 infection and medicines in pregnancy - a multinational registry based study	European Medicines Agency (EMA)	Aarhus U., ARS Toscana, BIPS, BPE, FISABIO, RTI-HS, UMCU, Utrecht U.	2020
MINERVA: 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, FISABIO, KI, PHARMO, UMCU, Utrecht U.	2020
Drug-drug interactions between dicloxacillin/flucloxacillin and DOACs	N/A	SDU, Utrecht U.	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
Renin-angiotensin-aldosterone system inhibitors and adverse outcomes of COVID-19: a Danish nationwide cohort study	Aarhus University	Aarhus U., SDU	2020
Adherence, persistence and switching patterns – once- and twice-daily direct oral anticoagulants	Daiichi Sankyo Europe GmbH	PHARMO, ARS Toscana, BIPS	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