Patient registries play an important role in post marketing surveillance of pharmaceuticals
Drug exposure and safety measurements through registries are well accepted by regulatory bodies and health authorities, and are often required in post-marketing surveillance. Registry goals and purposes vary, but when designed with the right approach and built with the right analytics technology, they improve care.
ENDPOINTS OF OBSERVATIONAL STUDIES
A patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes.
Patient registries are used to prospectively collect, analyse and disseminate data on a group of patients with specific characteristics in common having a certain treatment or using a health-related service.
Registries are conducted in a real-world setting in order to measure a product’s effectiveness and are useful tools that can help validate its safety and efficacy.
OXON provides national and international disease and product (drug and device) registries in all therapeutic areas, including orphan and rare diseases.
REGISTRIES FOR A REAL-WORLD VIEW
Patient registries are used to:
• Support the European Medicines Agency’s (EMA’s) initiatives for early access to medicines.
• Monitor orphan drugs, personalized medicines, advanced therapies and biosimilars
• Provide insight into the use of medicines under real-life conditions
• Improve healthcare systems, through disease registries and through product-specific registries
• To collect cost data and effectiveness data for use in modelling cost-effectiveness.
Thus, studies derived from properly designed and executed patient registries can provide a real-world view of clinical practice, patient outcomes, safety, and clinical, comparative, and cost-effectiveness, and can serve evidence development and decision-making purposes.