Statistical Papers

, Volume 60, Issue 2, pp 45–54 | Cite as

Randomization-based inference and the choice of randomization procedures

  • Yanying Wang
  • William F. RosenbergerEmail author
  • Diane Uschner
Regular Article


In testing the significance of treatment effects in randomized clinical trials (RCTs), randomization-based inference is distinguished from population-based parametric and nonparametric inference, such as the t-test or permutation tests, taking into account three properties: preservation of type I error rate, relation of power to the randomization procedure, and flexibility in choosing the test statistic. In this paper, we revisit rationale of the properties and provide justification through simulations. We propose that the choice of randomization procedures and the analysis of RCTs can be facilitated by the application of randomization-based inference.


Randomization tests Population tests Randomization procedure Type I error rate Statistical power 



  1. Anscombe FJ (1948) The validity of comparative experiments. J R Stat Soc Ser A 111:181–211MathSciNetCrossRefGoogle Scholar
  2. Parhat P, Rosenberger WF, Diao G (2014) Conditional monte carlo randomization tests for regression models. Stat Med 33:3078–3088MathSciNetCrossRefGoogle Scholar
  3. Pesarin F (2001) Multivariate permutation tests: with applications in biostatistics. Wiley, New YorkzbMATHGoogle Scholar
  4. Plamadeala V, Rosenberger WF (2012) Sequential monitoring with conditional randomization tests. Ann Stat 40:30–44MathSciNetCrossRefzbMATHGoogle Scholar
  5. Rosenberger WF, Lachin JM (2016) Randomization in clinical trials: theory and practice, 2nd edn. Wiley, HobokenCrossRefzbMATHGoogle Scholar
  6. Rosenberger WF, Uschner D, Wang Y (2018) The 15th armitage lecture-randomization: the forgotten component of the randomized clinical trial. Stat Med 38:1–12CrossRefGoogle Scholar

Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of StatisticsGeorge Mason UniversityFairfaxUSA
  2. 2.The George Washington University Biostatistics CenterRockvilleUSA

Personalised recommendations