Optimal Sample Size Determination for Medium or Large Clinical Study

Title	Optimal Sample Size Determination for Medium or Large Clinical Study
Creator	姜志銘 Jiang, Thomas Jyh-Ming
Contributor	應數系
Key Words	Fisher’s Exact Test; Normal Approximation Test; Clinical Trial; Clinical Significance; Efficacy Rate
Date	2017-06
Date Issued	12-Jul-2017 15:13:43 (UTC+8)
Summary	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.
Relation	Biomedical Statistics and Informatics, 2(3), 103-106
Type	article
DOI	http://dx.doi.org/10.11648/j.bsi.20170203.14

dc.contributor	應數系
dc.creator (作者)	姜志銘	zh-tw
dc.creator (作者)	Jiang, Thomas Jyh-Ming	en-US
dc.date (日期)	2017-06
dc.date.accessioned	12-Jul-2017 15:13:43 (UTC+8)	-
dc.date.available	12-Jul-2017 15:13:43 (UTC+8)	-
dc.date.issued (上傳時間)	12-Jul-2017 15:13:43 (UTC+8)	-
dc.identifier.uri (URI)	http://nccur.lib.nccu.edu.tw/handle/140.119/111019	-
dc.description.abstract (摘要)	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.
dc.format.extent	160774 bytes	-
dc.format.mimetype	application/pdf	-
dc.relation (關聯)	Biomedical Statistics and Informatics, 2(3), 103-106
dc.subject (關鍵詞)	Fisher’s Exact Test; Normal Approximation Test; Clinical Trial; Clinical Significance; Efficacy Rate
dc.title (題名)	Optimal Sample Size Determination for Medium or Large Clinical Study
dc.type (資料類型)	article
dc.identifier.doi (DOI)	10.11648/j.bsi.20170203.14
dc.doi.uri (DOI)	http://dx.doi.org/10.11648/j.bsi.20170203.14