Abstract
This chapter introduces registries and registry trials. Registries are collections of observational data about individuals with a common exposure or condition. They are useful tools for the assessment of the natural history of diseases and can complement the information obtained in a randomized clinical trial with information about the real-world outcomes of efficacious interventions. The registry trial is a relatively new study design that uses a registry as a source of information about trial participants. This offers the ability to rapidly recruit participants and forego the traditional and labor-intensive case report form, reducing cost and effort. Registry trials are limited by the type and quality of data in the registry. Thus, registries should be carefully assessed for quality and relevance before a registry trial is undertaken.
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