Innovation in clinical trials is vital for the future of medical research and development, and clinical quality registries offer significant opportunities by providing a rich source of real-world data. Clinical quality registries collect individual-based clinical data and serve a clinical, scientific and/or public health purpose.
In clinical trials, such registries can be used to determine how well randomized controlled trial (RCT) data represent the target population, and provide comparator groups for single-arm trials when RCTs are not feasible or ethical. Further, registries provide an important source of data on rare diseases and patients treated with advanced therapy medicinal products (ATMP), including gene therapy.
Clinical quality registries can also be integrated into clinical trial designs to gather data on treatments, outcomes and follow-up. This approach can reduce effort and time commitments for both investigators and study participants.
Sweden’s comprehensive clinical quality registries provide a unique opportunity to leverage these benefits in clinical trials. Furthermore, the European Health Data Space (EHDS) initiative, designed to facilitate the reuse of health data, opens new possibilities for using registry data in clinical trials across the European Union.
Read the EMA guideline on registry-based studies: Guideline on registry-based studies | European Medicines Agency (europa.eu)
