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|
|Cohort monitoring of Adverse Events of Special Interest and COVID-19 diagnoses prior to and after COVID-19 vaccination||European Medicines Agency (EMA)||UMCU, ARS Toscana, PHARMO, 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|
|Pregnancy outcomes in women exposed to oral cladribine: a multi-country cohort database study||Merck Healthcare KGaA||RTI-HS, Dundee U.||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|
|Adherence, persistence and switching patterns – once- and twice-daily direct oral anticoagulants||Daiichi Sankyo Europe GmbH||PHARMO, ARS Toscana, BIPS||2019|
|Impact of EU label changes and pregnancy prevention programme for medicinal products containing valproate and related substances: risk awareness and adherence||European Medicines Agency (EMA)||Utrecht U., UMCU, ARS Toscana, PHARMO||2019|
|Impact of EU label changes and revised pregnancy prevention programme for oral retinoid containing medicinal products: utilization and prescribing trends||European Medicines Agency (EMA)||UMCU, ARS Toscana, BPE, IDIAPJGol, PHARMO||2019|
|Drug utilisation study of Radium 223 under routine clinical practice in Europe||Bayer AG||RTI-HS, Aarhus U., BIPS||2019|
|The BRodalumab Assessment of Hazards: A Multinational Safety (BRAHMS) study in electronic healthcare databases||LEO Pharma||SDU, ARS Toscana, BIPS, PHARMO||2018|
|Impact of EU label changes for hydroxyzine products: post-referral prescribing trends||European Medicines Agency (EMA)||Dundee U., PHARMO, SDU||2018|
|Multisource Surveillance Study of Pregnancy and Infant Outcomes in Ocrelizumab-Exposed Women With Multiple Sclerosis||Roche||RTI-HS, Aarhus U.||2017|
|Impact of EU label changes for systemic diclofenac products: post-referral prescribing trends||European Medicines Agency (EMA)||Dundee U., PHARMO, SDU||2017|