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Randomization in clinical studies

  • Lim, Chi-Yeon (Department of Biostatistics, Dongguk University College of Medicine, Dongguk University Ilsan Hospital) ;
  • In, Junyong (Department of Anesthesiology and Pain Medicine, Dongguk University Ilsan Hospital)
  • Received : 2019.02.08
  • Accepted : 2019.03.18
  • Published : 2019.06.01

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

References

  1. Uschner D, Schindler D, Hilgers RD, Heussen N. randomizeR: an R package for the assessment and implementation of randomization in clinical trials. J Stat Softw 2018; 85: 1-22.

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