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題名:非虛假設比例檢驗及其在臨床試驗中的應用
書刊名:中國統計學報
作者:趙國龍
作者(外文):Zhao, Guo-long
出版日期:2003
卷期:41:1
頁次:頁21-37
主題關鍵詞:Monte Carlo方法比例生物等效性功效函數非虛假設假設檢驗Binomial proportionBio-equivalenceHypothesis testMonte Carlo methodNon-null hypothesisPower function
原始連結:連回原系統網址new window
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本文提出一種非虛假設比倒按驗。方法為以非虛假設取代虛假設將經典單樣本,兩樣本,和多樣本比例檢驗加以擴展,並推導所需樣本量及功效函數。用Monte Carlo方法展示其行為。本文所提之檢驗計算簡便,當最小臨床承認差量取零時還原為對應經典檢驗,其觀測功效與期望功效吻合。本文所提之檢驗可用於以治療–對照差臨床意義或生物等效性研究為目的的臨床試驗。附有工作實例描述過程。
A test of non-null hypothesis on proportion is proposed. It is derived from the classical one-, two- and multi-sample test on binomial proportion using the non-null hypothesis in place of the null hypothesis. The required sample size and power function are obtained by the same way. Its performance was demonstrated through simulation. It is quite simple in calculation. It reduces to its classical counterpart when the minimal clinically relevant difference equals zero. Its observed power coincides with the prescribed power. The test is appropriate with the clinical trials for the clinical significance of treatment-control difference or bio-equivalence. A worked example illustrates the methodology.
期刊論文
1.Sahai, H.、Khurshid, A.(1996)。Formulae and tables for the determination of sample sizes and power in clinical trials for testing differences in proportions for the two-sample design: a review。Statistics in Medicine,15,1-21。  new window
2.Lachin, J. M.(1981)。Introduction to sample size determination and power analysis for clinical trials。Controlled Clinical Trial,2,93-113。  new window
3.Dunnett, C. W.、Gent, M.(1977)。Significance Testing to Establish Equivalence between Treatments, with Special Reference to Data in the Form of 2 x 2 Tables。Biometrics,33,593-602。  new window
4.Halperin, M.、Rogot, E.、Gurian, J.、Ederer, F.(1968)。Sample size for medical trials with special reference to long-term therapy。J Chron Dis,21,13-24。  new window
5.Lachin, J. M.(1977)。Sample size determinations for r x c comparative trials。Biometrics,33,315-324。  new window
圖書
1.賴世隆(2001)。中國臨床試驗。廣州:廣東人民出版社。  延伸查詢new window
2.方積乾、陸盈(2002)。現代醫學統計學。北京:人民衛生出版社。  延伸查詢new window
3.Fleiss, J. L.(1981)。Statistical Methods for Rates and Proportions。New York:John Wiley & Sons。  new window
4.Haynam, G. E.、Govindarajulu, Z.、Leone, F. C.(1962)。Tables of the cumulative non-central chi-square distribution。  new window
圖書論文
1.Lachin, J. M.(1982)。Statistical inference in clinical trials。The randomized clinical trial and therapeutic decisions。New York:Marcel Dekker。  new window
 
 
 
 
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