Justin A. Ezekowitz, MBBCh, MSc
Professor, Department of Medicine
Co-Director, Canadian VIGOUR Centre
Director, Cardiovascular Research, University of Alberta
Cardiologist, Mazankowski Alberta Heart Institute
Cardiovascular Trials Over 2 Decades: Progress on Pragmatism?
Pragmatic clinical trials; PRECIS-2; Cardiovascular trials; Enrollment of women
- Pragmatic clinical trials are “designed for the primary purpose of informing decision-makers regarding the comparative balance of benefits, burdens and risks of a biomedical or behavioral health intervention at the individual or population level” (Califf & Sugarman, 2015).
- This study examined how pragmatic or explanatory cardiovascular (CV) randomized controlled trials are; whether the level of pragmatism in CV trials has changed over 2 decades; and whether the proportion of women enrolled in CV trials has changed over 2 decades.
- No clinical trial is completely explanatory or pragmatic. In this study, trials that scored higher on pragmatism (using the PRECIS-2 tool) had more sites, a larger sample size, longer follow up, and mortality as a primary endpoint.
Randomized controlled trials that were published in general medicine journals scored higher in pragmatism than those published in CV journals. Pragmatism has increased over time in CV trials.
While women account for ~45% of the burden of CV diseases, they are underrepresented in CV randomized controlled trials, with less than one-third of trial participants. There was no difference between pragmatic trials and other trials in terms of women’s enrollment.
Initiatives that focus on patient, clinician, and trial design factors are needed to address the gender gap in trial enrollment.
Read more about the PRECIS-2 tool in the Living Textbook, and Dr. Ezekowitz’s research in Trends in the Explanatory or Pragmatic Nature of Cardiovascular Clinical Trials Over 2 Decades (JAMA Cardiology, 2019).