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Harrington J, Gouda P, Ezekowitz J, et al. Exploring the pragmatic-explanatory spectrum across cardiovascular clinical trials. Contemp Clin Trials. 2021;113:106646doi: 10.1016/j.cct.2021.106646.
Harrington, J., Gouda, P., Ezekowitz, J., & Mentz, R. J. (2021). Exploring the pragmatic-explanatory spectrum across cardiovascular clinical trials. Contemporary clinical trials, 113106646. https://doi.org/10.1016/j.cct.2021.106646
Harrington, Josephine, et al. "Exploring the pragmatic-explanatory spectrum across cardiovascular clinical trials." Contemporary clinical trials vol. 113 (2021): 106646. doi: https://doi.org/10.1016/j.cct.2021.106646
Harrington J, Gouda P, Ezekowitz J, Mentz RJ. Exploring the pragmatic-explanatory spectrum across cardiovascular clinical trials. Contemp Clin Trials. 2021 Dec 01;113:106646. doi: 10.1016/j.cct.2021.106646. Epub 2021 Dec 01. PMID: 34863929.
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Contemp Clin Trials. 2021 Dec 01;113:106646. doi: 10.1016/j.cct.2021.106646. Epub 2021 Dec 01.

Exploring the pragmatic-explanatory spectrum across cardiovascular clinical trials.

Contemporary clinical trials

Josephine Harrington, Pishoy Gouda, Justin Ezekowitz, Robert J Mentz

Affiliations

  1. Duke Clinic Research Institute, Durham, NC, United States; VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.
  2. Duke Clinic Research Institute, Durham, NC, United States; VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada. Electronic address: [email protected].

PMID: 34863929 DOI: 10.1016/j.cct.2021.106646

Abstract

Clinical trials are a cornerstone of modern medicine and form the backbone of evidence that is used to create evidence-based guidelines. Contemporary clinical trials have tended to be quite explanatory, assessing an intervention in ideal conditions with highlyprotocolized interventions, strict inclusion/exclusion criteria, high resource utilization and with frequent (and often specialized) follow-up. In conjunction with decreased event-rates due to the improvement of cardiovascular care, this has resulted in increasingly complex, large, clinical trials that are associated with exponentially increasing costs. This has led to a strong push for streamlined trials that more truly represent "real world" settings and conduct. Such pragmatic trials emphasize "real world" conduct, including broader inclusion criteria that lead to more typical and less carefully selected patient populations, and more realistic trial setting and execution elements. We explore the spectrum of pragmatism across cardiovascular clinical trials, highlighting novel innovations and trends over the past decade.

Copyright © 2021 Elsevier Inc. All rights reserved.

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