Significance and limitations of randomization in clinical trials

DOI Web Site Web Site 1 Citations 19 References Open Access
  • Teramukai Satoshi
    Department of Biostatistics, Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Bibliographic Information

Other Title
  • 臨床試験におけるランダム化の意義と限界
  • リンショウ シケン ニ オケル ランダムカ ノ イギ ト ゲンカイ

Search this article

Abstract

<p>Fisher’s randomization rule has been widely viewed as a revolutionary invention in experimental design. The three rationales of randomization in clinical trials are (i) randomization ensures that known and unknown confounders are asymptotically controlled, (ii) the use of randomization itself provides the basis of statistical inference, supposing patients in a clinical trial are a non-random sample of a population, and (iii) the act of randomization mitigates selection bias by providing unpredictability in treatment allocation. Randomized controlled trials have been the gold standard for more than five decades, while such trials may be costly, inconvenient and ethically challenging. Some Fisherian statisticians have emphasized the importance of design-based inference based on randomization test, however some statisticians does not agree with them. From the Bayesian point of view, the randomization sequence is ancillary for a parameter of interest, and randomization itself is not absolutely essential although it may sometimes be helpful. In this review, I provide an overview of the rationales of randomization and the related topics, and discuss the significance and limitations of randomization in clinical trials.</p>

Journal

Citations (1)*help

See more

References(19)*help

See more

Related Projects

See more

Keywords

Details 詳細情報について

Report a problem

Back to top