Pragmatic Trials

Pragmatic clinical trials (PCTs) are randomized controlled trials designed to determine how a health technology works in usual clinical practice. They are often contrasted with explanatory trials, which evaluate how well medical products work under optimal circumstances in a carefully chosen, treatment-adherent patient population to maximize the chance of observing a biological effect of a new treatment. In contrast to explanatory trials, PCTs generally include a broader range of patients by reducing the number of inclusion / exclusion criteria, generally include a broader range of study sites (versus only including academic medical centers) and generally include outcomes that are aligned with the evidence needs of post-regulatory decision makers. PCTs address practical questions about the risks, benefits, and costs of an intervention as they would occur in routine clinical practice.