Process / pipelineClinical / epidemiology

Pragmatic Randomized Clinical Trial — Effectiveness in Real-World Care

A pragmatic randomized clinical trial (pragmatic RCT) is an interventional study that tests whether a treatment works under routine clinical conditions, as opposed to the tightly controlled setting of an explanatory trial. It prioritizes broad eligibility, flexible delivery, and patient-relevant outcomes to answer the question 'Does this treatment work in everyday practice?' rather than 'Can this treatment work under ideal circumstances?' The distinction between pragmatic and explanatory trials was formally articulated by Schwartz and Lellouch in 1967 and operationalized by the PRECIS tool in 2009.

Open in MethodMindSoonVideoSoon

Read the full method

Members only

Sign in with a free account to read this section.

Sign in

Sources

  1. Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648. DOI: 10.1016/0021-9681(67)90041-0
  2. Thorpe, K. E., Zwarenstein, M., Oxman, A. D., Treweek, S., Furberg, C. D., Altman, D. G., ... & Chalkidou, K. (2009). A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers. Journal of Clinical Epidemiology, 62(5), 464–475. DOI: 10.1016/j.jclinepi.2008.12.011

Related methods

Referenced by

ScholarGatePragmatic randomized clinical trial (Pragmatic Randomized Controlled Trial). Retrieved 2026-06-04 from https://scholargate.app/en/epidemiology/pragmatic-randomized-clinical-trial