메뉴 건너뛰기




Volumn 7, Issue 2, 2008, Pages 130-141

Methods for one-sided testing of the difference between proportions and sample size considerations related to non-inf eriority clinical trials

Author keywords

Difference in proportions; Non inferiority trials; One sided testing; Sample size; Sample size allocation

Indexed keywords

ANALYTICAL ERROR; ARTICLE; CALCULATION; CONFIDENCE INTERVAL; CONTROLLED STUDY; HUMAN; INTERMETHOD COMPARISON; MATHEMATICAL COMPUTING; POWER ANALYSIS; SAMPLE SIZE; SIMULATION; STATISTICAL ANALYSIS; CLINICAL TRIAL; COMPUTER SIMULATION; METHODOLOGY;

EID: 46449089499     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.287     Document Type: Article
Times cited : (22)

References (8)
  • 1
    • 0033566769 scopus 로고    scopus 로고
    • ICH harmonized tripartite guideline, statistical principles for clinical trials
    • ICH Expert Working Group
    • ICH Expert Working Group. ICH harmonized tripartite guideline, statistical principles for clinical trials. Statistics in Medicine 1999; 18:1905-1942.
    • (1999) Statistics in Medicine , vol.18 , pp. 1905-1942
  • 2
    • 33646759912 scopus 로고    scopus 로고
    • European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) guideline on the choice of the non-inferiority margin
    • Efficacy Working Party
    • Efficacy Working Party. European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) guideline on the choice of the non-inferiority margin. Statistics in Medicine 2006; 25:1628-1638.
    • (2006) Statistics in Medicine , vol.25 , pp. 1628-1638
  • 3
    • 0029128443 scopus 로고
    • Comparison of tests and sample size formulae for proving therapeutic equivalence based on the difference of binomial Methods for the difference between proportions 141 probabilities
    • Roebruck P, Kühn A. Comparison of tests and sample size formulae for proving therapeutic equivalence based on the difference of binomial Methods for the difference between proportions 141 probabilities. Statistics in Medicine 1995; 14: 1583-1594.
    • (1995) Statistics in Medicine , vol.14 , pp. 1583-1594
    • Roebruck, P.1    Kühn, A.2
  • 4
    • 33646566504 scopus 로고    scopus 로고
    • A note on comparing two binomial proportions in confirmatory non-inferiority trials
    • Li Z, Chuang-Stein C. A note on comparing two binomial proportions in confirmatory non-inferiority trials. Drug Information Journal 2006; 40:203-208.
    • (2006) Drug Information Journal , vol.40 , pp. 203-208
    • Li, Z.1    Chuang-Stein, C.2
  • 5
    • 0034554907 scopus 로고    scopus 로고
    • Simple and effective confidence intervals for proportions and difference of proportions results from adding two successes and two failures
    • Agresti A, Caffo B. Simple and effective confidence intervals for proportions and difference of proportions results from adding two successes and two failures. The American Statistician 2000; 54(4): 280-288.
    • (2000) The American Statistician , vol.54 , Issue.4 , pp. 280-288
    • Agresti, A.1    Caffo, B.2
  • 6
    • 0032580377 scopus 로고    scopus 로고
    • Interval estimation for the difference between independent proportions: Comparison of eleven methods
    • Newcombe RG. Interval estimation for the difference between independent proportions: comparison of eleven methods. Statistics in Medicine 1998; 17: 873-890.
    • (1998) Statistics in Medicine , vol.17 , pp. 873-890
    • Newcombe, R.G.1
  • 7
    • 0025633361 scopus 로고
    • Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk
    • Farrington CP, Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Statistics in Medicine 1990; 9:1447-1454.
    • (1990) Statistics in Medicine , vol.9 , pp. 1447-1454
    • Farrington, C.P.1    Manning, G.2
  • 8
    • 46749093199 scopus 로고    scopus 로고
    • SAS®, Version 8.02. SAS Institute Inc, Cary, NC, 1999
    • SAS®, Version 8.02. SAS Institute Inc.: Cary, NC, 1999.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.