Schwartz and Lellouch were the first to use the word “pragmatic” in relation to clinical trials in 1967. They defined a pragmatic trial as a trial designed to help chose between care options, as opposed to an explanatory trial which is used to test causal research hypotheses, for example about biological processes.
About 30 years later Roland and Torgerson made the distinction between these two types of trial in a slightly different way, explaining that explanatory trials evaluate efficacy, the effect of treatment in ideal conditions and pragmatic trials evaluate effectiveness, the effect of treatment in routine clinical practice.
In the twenty-first century it has been recognised that there is, in fact, a spectrum of trials with very explanatory trials at one end and very pragmatic trials at the other end.
Schwartz, D. and Lellouch, J. (1967) ‘Explanatory and Pragmatic attitudes in Therapeutical Trials’, J. chron, Vol. 20, pp. 637-648.
Roland, M. and Torgerson, D, J. (1998) ‘What are pragmatic trials’, BMJ, Vol. 316 (7127), pp. 285-285
CONSORT for pragmatic trials
Explore the resources below to find out more about pragmatic clinical trials.
Watch PCTU Director Professor Richard Hooper giving a talk titled 'The Shape of Trials'.
Former PCTU Director Professor Sandra Eldridge provides an introduction to pragmatic clinical trials, presented at the Belgian Health Care Knowledge Centre (KCE) in June 2017:
Professor Sandra Eldridge answers the question, "What is a pragmatic trial?" as part of the Q&A session at the Belgian health Care Knowledge Centre (KCE) in June 2017:
Professor Sandra Eldridge gives her top 10 tips for launching pragmatic trials, in her keynote address to the Pragmatic Trials Stream virtual workshop at the Schulich School of Medicine & Dentistry, Western University, Ontario, Canada, in April 2022.