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Protection of Random Assignment

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Behavioral Clinical Trials for Chronic Diseases

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Abstract

Existence of an alternative explanation for the benefit of a treatment is a confounder. It is a nuisance “passenger” variable that rides along with treatment and undermines the ability to make causal inferences. This chapter focuses on why random assignment is so powerful and should be protected. It presents a history of attempts to answer the question of whether or not a treatment works, and the arrival at random assignment as the best way to make causal inferences about the benefits of a treatment. It defines confounding as an error of interpretation and the essential role of avoiding it by protecting the random assignment. It then goes on to illustrate ways to protect random assignment in the design, conduct, and analyses of a trial, with particular attention to the central role of identifying a patient-centered target population, recruiting it, retaining it, and insuring that all randomized participants are included in the evaluation of trial results.

“Daniel and his three companions were young Israelites who were taken to serve in the palace of the king of Babylon because they were of noble royal family, without physical defect, handsome, versed in wisdom, and competent. Daniel determined he would not defile himself with the King’s food or wine. He asked the overseer:

‘Please test us for 10 days and let us be given some vegetables

to eat and water to drink. Then let our appearance be compared

to the appearance of youths who are eating the King’s choice food.’

At the end of 10 days, their appearance seemed better and they were fatter than any of the youths who had been eating the King’s food. So the overseer let them continue to eat vegetables and drink water instead of what the king provided.”

Bible, Old Testament, Book of Daniel 1:16

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Authors and Affiliations

  1. Department of Preventive Medicine, Rush University Medical Center, Chicago, IL, USA

    Lynda H. Powell

  2. College of Nursing, Villanova University, Villanova, PA, USA

    Peter G. Kaufmann

  3. Department of Psychiatry, Washington University in St. Louis, St. Louis, MO, USA

    Kenneth E. Freedland

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  1. Lynda H. Powell
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  2. Peter G. Kaufmann
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  3. Kenneth E. Freedland
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Powell, L.H., Kaufmann, P.G., Freedland, K.E. (2021). Protection of Random Assignment. In: Behavioral Clinical Trials for Chronic Diseases. Springer, Cham. https://doi.org/10.1007/978-3-030-39330-4_8

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