Hybrid Studies: A Foundation For Comprehensive Evidence Development

Hybrid studies, which integrate prospective and existing health data, can generate evidence of drug and device safety and effectiveness through long-term patient follow-up in real-world settings.

Hybrid studies are growing in popularity. This approach utilizes existing data from sources such as electronic medical records (EMRs) and pharmacy claims, and collects other data that are essential to the study purpose. Hybrid studies take advantage of the increasing quantities of data that are now stored in electronic format. Some health systems are developing processes that allow reasonable use of their data for purposes beyond that which they were originally intended. The methods used to link information from EMR and claims to “identifiable” patients and physicians are improving. Clinical data have been collected electronically for many years, but searching for specific information within these records was laborious. Today, clinical information can be assembled using post hoc common data formats, driving down the overall cost of data collection.

The devil, however, is in the details. Hybrid studies are useful to study everyday medical practice and real-world patients, but...

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