Clinical Research Methodology 3: Randomized Controlled Trials

Anesth Analg. 2015 Oct;121(4):1052-1064. doi: 10.1213/ANE.0000000000000862.

Abstract

Randomized assignment of treatment excludes reverse causation and selection bias and, in sufficiently large studies, effectively prevents confounding. Well-implemented blinding prevents measurement bias. Studies that include these protections are called randomized, blinded clinical trials and, when conducted with sufficient numbers of patients, provide the most valid results. Although conceptually straightforward, design of clinical trials requires thoughtful trade-offs among competing approaches-all of which influence the number of patients required, enrollment time, internal and external validity, ability to evaluate interactions among treatments, and cost.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Biomedical Research / methods*
  • Biomedical Research / standards*
  • Humans
  • Patient Selection
  • Randomized Controlled Trials as Topic / methods*
  • Randomized Controlled Trials as Topic / standards*
  • Research Design / standards