Clinical research is a discipline prone to the use of technical terms that may be particularly at risk for misunderstanding given the complex interpretation that is required. In this century, what is happening with the word ‘pragmatic’ when describing a randomized controlled trial (RCT) with medicines deserves a public reflection. Explanatory trials are conducted in ideal conditions to assess the comparative efficacy of interventions and are useful to explain whether interventions work. Pragmatic trials are those conducted in a way that resembles usual clinical practice conditions to assess the comparative effectiveness of interventions in a manner directly applicable for decision-makers. This, however, did not prevent 36% of authors of placebo-controlled, or prelicensing trials to identify their medicines RCTs as pragmatic in the title of their articles. The current situation is such that scientific literature has accepted that ‘pragmatic’ can convey the original meaning—that obtained in trials mimicking usual clinical practice—and a distorted one—that is focused on streamlining any trial procedure. Those involved in clinical trials should emphasize the importance of precision in the use of terms when describing RCTs through standardized solutions when possible. Unless clinical trial stakeholders agree when it would be correct to label an RCT as pragmatic, in a short period of time the term will be in danger of becoming meaningless. It is suggested that the Enhancing the Quality and Transparency of Health Research (EQUATOR) network, the Consolidated Standards of Reporting Trials (CONSORT) group and the International Committee of Medical Journal Editors (ICMJE) could address this topic and provide a consensus way forward.
- biomedical research
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Contributors RDR wrote the first draft of the manuscript. RJM and FRR provided comments and edits throughout the drafting process for important intellectual content. All authors approved the final version of the manuscript and are accountable for all aspects included in it.
Funding This work required no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests RDR has received honorarium from Palex Medical for giving a lecture on low-risk pragmatic trials. RJM receives research support from Amgen, AstraZeneca, Bayer, Cytokinetics, American Regent, Medtronic, Merck, Novartis and Sanofi; honoraria from Abbott, Amgen, AstraZeneca, Bayer, Boston Scientific, Cytokinetics, Janssen, Medtronic, Merck, Novartis, Roche, Sanofi and Vifor; and has served on an advisory board for Amgen, AstraZeneca, Cytokinetics, Merck, Novartis and Boehringer Ingelheim.
Provenance and peer review Not commissioned; externally peer reviewed.