According to an editorial published in JAMA Network Open, pragmatic clinical trials can leverage EHR data to assist decrease costs and human effort involved with randomized clinical trials. EHRs can also cut costs, as data collected from them does not require participant contracts or adjudications, which can be costly.
- Announcement: The commentary was written by cardiologists Mahmoud Rifai, MD, of Houston-based Baylor College of Medicine; Dipti Itchhaporia, MD, of Newport Beach, Calif.-based Hoag Medical Group; and Salim Virani, MD, Ph.D., of Baylor College of Medicine.
- Trails: The authors noted that randomized clinical trials have strong internal validity, but may not hold up in real-world applications, as clinical care dynamics differ from the controlled setting of a randomized trial.
- Limitations: Pragmatic trials, which are conducted in “everyday settings,” can cover limitations and costs associated with conducting traditional randomized clinical trials, the authors said in the commentary.
- Assessment: “Assessment of study outcomes via linkage with EMRs decreases the burden on the participants and the research team,” the authors said in the commentary. “This is especially important in the current COVID-19 pandemic.”
- Enhancement: Pragmatic trials, which are conducted in everyday clinical settings, aim to enhance the external validity of clinical research and cut costs associated with conducting traditional RCTs. The National Institutes of Health (NIH) has promoted pragmatic trials as a viable path forward given the availability of EHRs that permit the adoption of such trials.