PURPOSE: To discuss the opportunities and challenges of pooling data from Nordic registers for safety and outcome research drawing on experience with Nordic collaborators.

DESCRIPTION:

Authorities responsible for drug safety (including FDA and EMA) and pricing/reimbursement are increasingly requesting studies based on Real World Evidence (RWE). The workshop will show how the Nordic registers contain rich longitudinal patient data from cradle to grave across diseases, treatments, resource utilization and socio-economic status and facilitates monitoring and quality measurements at the patient level to support early intervention and improved management. The Nordic registries have similar data structure, validity, and potentials for longitudinal follow-up for epidemiological and health economic studies. Statistical power of rare exposures and interventions can be increased by pooling data from the Nordic health registers at the same time heterogeneity between countries can be assessed improving the interpretation of differences of effectiveness of treatment.

Comparative forecasting (of disease populations from observed incidence and prevalence) as well as modelling of drug treatment-lines/pathways from prescription data is possible across the Nordic countries and may, combined with data from the abundant clinical quality registers including laboratory data, provide information otherwise difficult to obtain.

Despite many similarities the use and pooling of health data from the Nordic countries require in-depth, local knowledge and time-consuming management of how to harmonize and combine data, considering local coding schemes and practices as well as variability in validity aspects. Collaboration across Nordic teams is essential for the process.

The workshop is relevant for researchers, sponsors, decision makers and payers and will cover 1) Discussion of opportunities and challenges as outlined above based on 2) Examples of safety and outcome studies combining health registers (i.e. patient, cancer, diabetes, prescription), health-economic and socio-economic (DRG&DAG/National Statistics) and clinical data. 3) The pooling and harmonization of individual data across countries.