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The Randomization Process

In: Fundamentals of Clinical Trials

Author

Listed:
  • Lawrence M. Friedman

  • Curt D. Furberg

    (Wake Forest University, School of Medicine)

  • David L. DeMets

    (University of Wisconsin, Department of Biostatistics & Medical Informatics)

Abstract

The randomized controlled clinical trial is the standard by which all trials are judged since other designs have certain undesirable features. In the simplest case, randomization is a process by which each participant has the same chance of being assigned to either intervention or control. An example would be the toss of a coin, in which heads indicates intervention group and tails indicates control group. Even in the more complex randomization strategies, the element of chance underlies the allocation process. Of course, neither trial participant nor investigator should know what the assignment will be before the participant’s decision to enter the study. Otherwise, the benefits of randomization can be lost. The role that randomization plays in clinical trials has been discussed in Chap. 5 as well as by numerous authors [1–12]. While not all accept that randomization is essential [11, 12], most agree it is the best method for achieving comparability between study groups and is the basis for statistical inference [2, 3].

Suggested Citation

  • Lawrence M. Friedman & Curt D. Furberg & David L. DeMets, 2010. "The Randomization Process," Springer Books, in: Fundamentals of Clinical Trials, edition 0, chapter 0, pages 97-117, Springer.
    • Handle: RePEc:spr:sprchp:978-1-4419-1586-3_6
    DOI: 10.1007/978-1-4419-1586-3_6
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