Volume 2, Issue 3, September 2017, Page: 103-106
Optimal Sample Size Determination for Medium or Large Clinical Study
Thomas Jyh-Ming Jiang, Department of Mathematical Sciences, National Chengchi University, Wen-Shan, Taipei, Taiwan
Received: Feb. 26, 2017;       Accepted: Mar. 13, 2017;       Published: Mar. 29, 2017
DOI: 10.11648/j.bsi.20170203.12      View  1298      Downloads  98
Abstract
Clinical trials are often costly, and time consuming. The ability to get new products into the market early is critical to the success of pharmaceutical and medical device companies. Most practitioners use Fisher's exact tests to determine the required sample size for testing efficacy rates. We shall argue that when the sample size is not too small, normal approximation tests should be used instead of Fisher's exact tests. Several different sets of hypotheses and their corresponding formulas to compute sample size for clinical trial based upon normal approximation test are given.
Keywords
Fisher’s Exact Test, Normal Approximation Test, Clinical Trial, Clinical Significance, Efficacy Rate
To cite this article
Thomas Jyh-Ming Jiang, Optimal Sample Size Determination for Medium or Large Clinical Study, Biomedical Statistics and Informatics. Vol. 2, No. 3, 2017, pp. 103-106. doi: 10.11648/j.bsi.20170203.12
Copyright
Copyright © 2017 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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