Randomized Trials Versus Common Sense and Clinical Observation: JACC Review Topic of the Week.

Fanaroff, Alexander C; Califf, Robert M; Harrington, Robert A; Granger, Christopher B; McMurray, John J V; Patel, Manesh R; Bhatt, Deepak L; Windecker, Stephan; Hernandez, Adrian F; Gibson, C Michael; Alexander, John H; Lopes, Renato D (2020). Randomized Trials Versus Common Sense and Clinical Observation: JACC Review Topic of the Week. Journal of the American College of Cardiology, 76(5), pp. 580-589. Elsevier 10.1016/j.jacc.2020.05.069

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Concerns about the external validity of traditional randomized clinical trials (RCTs), together with the widespread availability of real-world data and advanced data analytic tools, have led to claims that common sense and clinical observation, rather than RCTs, should be the preferred method to generate evidence to support clinical decision-making. However, over the past 4 decades, results from well-done RCTs have repeatedly contradicted practices supported by common sense and clinical observation. Common sense and clinical observation fail for several reasons: incomplete understanding of pathophysiology, biases and unmeasured confounding in observational research, and failure to understand risks and benefits of treatments within complex systems. Concerns about traditional RCT models are legitimate, but randomization remains a critical tool to understand the causal relationship between treatments and outcomes. Instead, development and promulgation of tools to apply randomization to real-world data are needed to build the best evidence base in cardiovascular medicine.

Item Type:

Journal Article (Review Article)


04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Windecker, Stephan


600 Technology > 610 Medicine & health








Nadia Biscozzo

Date Deposited:

18 Nov 2020 10:05

Last Modified:

18 Nov 2020 10:05

Publisher DOI:


PubMed ID:


Uncontrolled Keywords:

observational studies randomized controlled trials real-world data surrogate endpoints





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