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

Journal Article (Journal Article;Review)

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.

Full Text

Duke Authors

Cited Authors

  • Fanaroff, AC; Califf, RM; Harrington, RA; Granger, CB; McMurray, JJV; Patel, MR; Bhatt, DL; Windecker, S; Hernandez, AF; Gibson, CM; Alexander, JH; Lopes, RD

Published Date

  • August 4, 2020

Published In

Volume / Issue

  • 76 / 5

Start / End Page

  • 580 - 589

PubMed ID

  • 32731936

Pubmed Central ID

  • PMC7384793

Electronic International Standard Serial Number (EISSN)

  • 1558-3597

Digital Object Identifier (DOI)

  • 10.1016/j.jacc.2020.05.069


  • eng

Conference Location

  • United States