The main objectives of the GLORIA™-AF Registry Program are to:
- Characterize patients newly diagnosed with non-valvular AF at risk for stroke on a global level
- Study patterns, predictors and outcomes of different treatment regimens for stroke prevention in non-valvular AF
- Collect data on the safety and effectiveness of antithrombotic treatments, such as the long time standard of care VKA, and novel oral anticoagulants such as dabigatran etexilate.
GLORIA™-AF collects real-world data
in a real-world population
and in real-world population
and in actual clinical practice settings.
Although randomized clinical trials provide important data for the registration of new drugs, they generally study carefully selected groups of patients under controlled conditions. Physicians, payers, and patients all want evidence of the results in larger and more diverse populations and in situations that represent real-world conditions. A registry can provide supplementary data compared to randomized clinical trials, which have more strict inclusion criteria and dictated monitoring schemes.
Disease registries and observational studies are an effective tool to observe the course of a disease and evaluate treatment effectiveness and safety, investigate the variations in the outcomes and to provide insight into factors that affect patient survival. This is especially important when evaluating new therapies such as novel oral anticoagulants for stroke prevention in AF. Real-world data allow the exploration of disease management patterns, treatment safety monitoring and identification of optimization strategies in clinical practice, which are vital for studying broad patient populations in relation to co-morbidities and co- medications.
Figure 3: GLORIA™-AF Registry Program overview
In a world of limited resources and patients with a myriad of risk factors and health conditions, it is for the benefit of all to understand the patients' characteristics, and to determine the safety, the effectiveness and the outcomes of treatments under a variety of real-world scenarios and in the populations that they serve.
For more information about Registries, please read "Registries for Evaluating Patient Outcomes: A User's Guide"
published by the Agency for Healthcare Research and Quality (AHRQ). This is a landmark federal publication providing key information on developing, operating and evaluating patient registries. The handbook provides tools intended to help evaluate the quality of a patient registry.