The Quantify Research team has years of experience of designing, supporting, and managing post-authorization studies, and has been a proud partner to the European Medicines Agency-coordinated ENCePPย (European Network for Centres of Pharmacoepidemiology and Pharmacovigilance) initiative since 2020.
The Nordic data landscape is uniquely suited for studies on drug utilization, assessments of risk minimization measures, and long-term safety, due to several key factors:
๐๐๐ญ๐ข๐จ๐ง๐๐ฅ ๐๐จ๐ฏ๐๐ซ๐๐ ๐ ๐๐ง๐ ๐ฆ๐ข๐ง๐ข๐ฆ๐๐ฅ ๐ฅ๐จ๐ฌ๐ฌ ๐ญ๐จ ๐๐จ๐ฅ๐ฅ๐จ๐ฐ-๐ฎ๐ฉ
– Citizens are covered from birth to death, with no requirement of continuous enrolment as would be the case with claims data
– Deterministic linkage based on national personal identity numbers
๐๐จ๐ง๐ ๐ข๐ญ๐ฎ๐๐ข๐ง๐๐ฅ๐ข๐ญ๐ฒ ๐จ๐ ๐๐๐ญ๐ ๐๐ง๐ ๐ฅ๐จ๐ง๐ -๐ญ๐๐ซ๐ฆ ๐๐จ๐ฅ๐ฅ๐จ๐ฐ-๐ฎ๐ฉ
– Registers generally date back decades, enabling the study of long-term safety far beyond the time horizons of clinical trials
๐๐ฅ๐จ๐ฌ๐ ๐ญ๐จ ๐ซ๐๐๐ฅ-๐ญ๐ข๐ฆ๐ ๐ฆ๐จ๐ง๐ข๐ญ๐จ๐ซ๐ข๐ง๐ ๐จ๐ ๐ฎ๐ฉ๐ญ๐๐ค๐ ๐จ๐ ๐ง๐๐ฐ ๐๐ซ๐ฎ๐ ๐ฌ
– Monitoring of uptake of new drugs allows for informed decision-making on when suitable sample size and power for key endpoints have been reached and studies may be initiated, minimizing cost and maximizing impact
๐๐ฏ๐๐ข๐ฅ๐๐๐ข๐ฅ๐ข๐ญ๐ฒ ๐จ๐ ๐ข๐ง๐๐จ๐ซ๐ฆ๐๐ญ๐ข๐จ๐ง ๐จ๐ง ๐๐๐ฎ๐ฌ๐ ๐จ๐ ๐๐๐๐ญ๐ก
– Cause of death registers based on medical death certificates enable the inclusion of cause-specific mortality as an endpoint
๐๐ข๐๐ก๐ง๐๐ฌ๐ฌ ๐จ๐ ๐๐๐ญ๐
– Linkage between different data sources allows for the capture and control of a wide range of observable potential confounding factors, such as concomitant medications, socioeconomic indicators, polypharmacy, comorbidities, disease and treatment history, etc.
– Disease-specific quality-of-care registries can provide additional key data on e.g. disease severity, patient-reported outcome measures, and more
– Richness of data also allows for emulating eligibility criteria of key clinical trials and comparing RCT-like cohorts to fully representative RWE cohorts
Get in touch if you would like to know more about our services and capabilities supporting post-authorization studies and regulatory-grade RWE!
