The role of EHRs in pragmatic clinical trials

Pragmatic clinical trials can use EHR data to help cut costs and human effort associated with randomized clinical trials, according to commentary published in JAMA Network Open on Dec. 28.

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, PhD, of Baylor College of Medicine. 

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. 

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.

EHRs can also cut costs, as data collected from them does not require participant contract or adjudications, which can be costly. 

"Assessment of study outcomes via linkage with EMRs decreases burden on the participants and the research team," the authors said in the commentary. "This is especially important in the current COVID-19 pandemic."


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