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

Randomization in clinical studies

Affiliations
  • 1Department of Biostatistics, Dongguk University College of Medicine, Goyang, Korea.
  • 2Department of Anesthesiology and Pain Medicine, Dongguk University Ilsan Hospital, Goyang, Korea. dragona1@dumc.or.kr

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.

Keyword

Adaptive randomization; Minimization; Random allocation; Randomization; Randomized controlled trial; Restrictive randomization; Simple randomization; Stratified randomization

MeSH Terms

Bias (Epidemiology)
Ethics
Probability Theory
Random Allocation*
Selection Bias

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