Chapter 23 – Issues in Randomization

In this chapter, we discuss key concepts and issues related to randomization and its implementation in clinical trials. After presenting the motivation for and history of randomization in clinical trials, we describe several methods of randomization. Common problems that threaten the integrity of randomization also will be discussed, including violation of the intent-to-treat principle, pseudorandom procedures, and missing data. We will conclude with a number of special topics, including adaptive randomization.