Research Methods 101: Pragmatic Clinical Trials

Earlier this month we wrote about randomized controlled trials and observational studies and the pros and cons of each for answering research questions. According to Dr. Marc Berger, executive vice president and senior scientist, Life Sciences, OptumInsight, there is a middle ground between the two: pragmatic clinical trials (PCTs).

Earlier this month we wrote about randomized controlled trials and observational studies and the pros and cons of each for answering research questions. According to Dr. Marc Berger, executive vice president and senior scientist, Life Sciences, OptumInsight, there is a middle ground between the two: pragmatic clinical trials (PCTs).

PCTs are randomized controlled trials (RCTs) that are designed to determine the risks, benefits, and costs of an intervention as they would occur in routine clinical practice. They are often contrasted with explanatory trials, which aim to determine whether a clinical intervention is effective under optimal circumstances (eg, in a carefully chosen, treatment-adherent patient population).

Dr. Berger explains the concept as well as the importance of using different types of comparative effectiveness research study designs to answer research questions.

Adapted from Making Informed Decisions: Assessing the Strengths and Weaknesses of Study Designs and Analytic Methods for Comparative Effectiveness Research