The NIH Collaboratory this week published a new chapter of its Living Textbook of Pragmatic Clinical Trials. The chapter, “Acquiring Real-World Data,” outlines strategies for obtaining real-world data for use in research.
“Real-world data” include data relating to the health status of a patient or the delivery of healthcare services. Common sources include electronic health records (EHRs), administrative claims, patient-reported outcomes, patient-generated health data, medical product and device registries, and databases relating to environmental factors or social determinants of health. Real-world data can support a number of activities in pragmatic clinical trials, such as patient identification and recruitment, monitoring of outcomes, and ascertainment of endpoints.
The new chapter includes the following sections:
- Introduction
- Common Real-World Data Sources
- Gaining Permission to Use Real-World Data
- Data Formats
- Methods of Access
The new chapter updates a previous resource, one of the most popular on the Living Textbook, based on work by experts in the NIH Collaboratory’s Electronic Health Records Core Working Group.