Translating Research Findings Into Practice—The Unfulfilled and Unclear Mission of Observational Data

Randomized clinical trials (RCTs) are rightfully valued as the primary source of research data that drives changes in practice and directs evidence-based care. However, the time and associated costs of initiating a trial and completing patient accrual and follow-up are important limitations. Among 28 phase 3 studies funded by the National Institute of Neurologic Disorders and Stroke of the National Institutes of Health, the total costs were more than $335 million, with a mean of approximately $12 million and a range from approximately $1 million to $64 million.1 By comparison, data from administrative claims, clinical registries, and electronic health records are readily available, cost-effective, and efficient for conducting observational research. These favorable features make observational data powerful tools that, when used properly, could potentially increase the rate at which scientific evidence is incorporated into contemporaneous clinical practice.