Interested in how the Quantify team can help in meeting post-authorization commitments through Nordic RWE?

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 ENCePP (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:

𝐍𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐜𝐨𝐯𝐞𝐫𝐚𝐠𝐞 𝐚𝐧𝐝 𝐦𝐢𝐧𝐢𝐦𝐚𝐥 𝐥𝐨𝐬𝐬 𝐭𝐨 𝐟𝐨𝐥𝐥𝐨𝐰-𝐮𝐩
– 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

𝐋𝐨𝐧𝐠𝐢𝐭𝐮𝐝𝐢𝐧𝐚𝐥𝐢𝐭𝐲 𝐨𝐟 𝐝𝐚𝐭𝐚 𝐚𝐧𝐝 𝐥𝐨𝐧𝐠-𝐭𝐞𝐫𝐦 𝐟𝐨𝐥𝐥𝐨𝐰-𝐮𝐩
– Registers generally date back decades, enabling the study of long-term safety far beyond the time horizons of clinical trials

𝐂𝐥𝐨𝐬𝐞 𝐭𝐨 𝐫𝐞𝐚𝐥-𝐭𝐢𝐦𝐞 𝐦𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠 𝐨𝐟 𝐮𝐩𝐭𝐚𝐤𝐞 𝐨𝐟 𝐧𝐞𝐰 𝐝𝐫𝐮𝐠𝐬
– 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

𝐀𝐯𝐚𝐢𝐥𝐚𝐛𝐢𝐥𝐢𝐭𝐲 𝐨𝐟 𝐢𝐧𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧 𝐨𝐧 𝐜𝐚𝐮𝐬𝐞 𝐨𝐟 𝐝𝐞𝐚𝐭𝐡
– Cause of death registers based on medical death certificates enable the inclusion of cause-specific mortality as an endpoint

𝐑𝐢𝐜𝐡𝐧𝐞𝐬𝐬 𝐨𝐟 𝐝𝐚𝐭𝐚
– 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!