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Randomization

Juliana Carvalho Ferreira, Ben Illigens, Felipe Fregni · Oxford University Press eBooks · 2018

Chapter 5 gives the reader an overview of a major important feature in every randomized clinical trial: the process of randomization. This chapter describes the main features of randomization, its importance, advantages, and disadvantages. It also discusses the most common methods of randomization (simple randomization, blocked randomization, stratified randomization, adaptive randomization), as well as what the investigator should take into consideration when choosing among these options. In this scenario, the challenges of defining a method in clinical trials with small sample sizes are also discussed. Additionally, the chapter explores the consequences that may arise from lack of randomization, such as selection bias. It also focuses on defining allocation concealment and its importance to the appropriate conduction of a study. In this chapter, the reader is taken through the entire process—from choosing a suitable randomization option to ensuring the appropriate implementation of the selected method.

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