Case Study: Registry #2
In the population at risk of atherothrombotic events, the objectives were to evaluate the long-term risk (yearly event rate) of atherothrombotic events in the global population and in different population subgroups, to compare long-term outcomes within different subject profiles, to evaluate the importance of cross risks of subjects at risk, and to define predictors of risk for subsequent atherothrombotic events.
Secondary objectives were to obtain data on treatment strategies used during the registry follow-up and on patient management for pharmaco-economic analysis.
64,000 patients were included (40,000 to 55,000 patients were planned) in approximately 5,500 sites in 38 countries (Europe, North and Latin America, and Asia). Services included data management, statistics, and medical writing.
• Size of the registry in terms of number of patients, sites and countries.
• Patient follow-up over a period of 2 years.
• Data collection (paper and electronic; 4 languages).
• One core protocol and 6 sub-studies.
• Development of a user-friendly, multi-lingual, hybrid paper-EDC solution.
• Centralized site Management.
Client very satisfied with the outcome of the registry in particular as concerns subject recruitment, quality of data and drop out rate at year 1 and 2.