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.
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
|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|