Randomization in clinical studies

Korean J Anesthesiol. 2019 Jun;72(3):221-232. doi: 10.4097/kja.19049. Epub 2019 Apr 1.

Abstract

Randomized controlled trial is widely accepted as the best design for evaluating the efficacy of a new treatment because of the advantages of randomization (random allocation). Randomization eliminates accidental bias, including selection bias, and provides a base for allowing the use of probability theory. Despite its importance, randomization has not been properly understood. This article introduces the different randomization methods with examples: simple randomization; block randomization; adaptive randomization, including minimization; and response-adaptive randomization. Ethics related to randomization are also discussed. The study is helpful in understanding the basic concepts of randomization and how to use R software.

Keywords: Adaptive randomization; Minimization; Random allocation; Randomization; Randomized controlled trial; Restrictive randomization; Simple randomization.

Publication types

  • Review

MeSH terms

  • Bias
  • Humans
  • Random Allocation*
  • Randomized Controlled Trials as Topic / statistics & numerical data*
  • Research Design
  • Selection Bias