메뉴 건너뛰기




Volumn 54, Issue 5, 2012, Pages 716-729

Sample size determination in clinical trials with multiple co-primary endpoints including mixed continuous and binary variables

Author keywords

Biserial correlation; Intersection union test; Latent variable; Multiplicity; Multivariate normal

Indexed keywords

MEDICAL APPLICATIONS; SAMPLING;

EID: 84865547626     PISSN: 03233847     EISSN: 15214036     Source Type: Journal    
DOI: 10.1002/bimj.201100221     Document Type: Article
Times cited : (23)

References (27)
  • 1
    • 84872633254 scopus 로고
    • The use of transformations
    • Bartlett, M. S. (1947). The use of transformations. Biometrics 3, 39-52.
    • (1947) Biometrics , vol.3 , pp. 39-52
    • Bartlett, M.S.1
  • 2
    • 31044442965 scopus 로고    scopus 로고
    • The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment
    • Breedveld, F. C., Weisman, M. H., Kavanaugh, A. F., Cohen, S. B., Pavelka, K., van Vollenhoven, R., Sharp, J., Perez, J. L. and Spencer-Green, G. T. (2006). The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis & Rheumatism 51, 26-37.
    • (2006) Arthritis & Rheumatism , vol.51 , pp. 26-37
    • Breedveld, F.C.1    Weisman, M.H.2    Kavanaugh, A.F.3    Cohen, S.B.4    Pavelka, K.5    van Vollenhoven, R.6    Sharp, J.7    Perez, J.L.8    Spencer-Green, G.T.9
  • 4
    • 0023021371 scopus 로고
    • Global cross-ratio models for bivariate, discrete, ordered responses
    • Dale, J. R. (1986). Global cross-ratio models for bivariate, discrete, ordered responses. Biometrics 42, 909-917.
    • (1986) Biometrics , vol.42 , pp. 909-917
    • Dale, J.R.1
  • 6
    • 84952511998 scopus 로고
    • A method for generating high-dimensional multivariate binary variates
    • Emrich, L. J. and Piedmonte, M. R. (1991). A method for generating high-dimensional multivariate binary variates. The American Statistician 45, 302-304.
    • (1991) The American Statistician , vol.45 , pp. 302-304
    • Emrich, L.J.1    Piedmonte, M.R.2
  • 8
    • 0001341675 scopus 로고
    • Numerical computation of multivariate normal probabilities
    • Genz, A. (1992). Numerical computation of multivariate normal probabilities. Journal of Computational and Graphical Statistics 1, 141-150.
    • (1992) Journal of Computational and Graphical Statistics , vol.1 , pp. 141-150
    • Genz, A.1
  • 9
    • 60749125498 scopus 로고    scopus 로고
    • Some controversial multiple testing problems in regulatory applications
    • Hung, H. M. and Wang, S. J. (2009). Some controversial multiple testing problems in regulatory applications. Journal of Biopharmaceutical Statistics 19, 1-11.
    • (2009) Journal of Biopharmaceutical Statistics , vol.19 , pp. 1-11
    • Hung, H.M.1    Wang, S.J.2
  • 10
    • 30544453568 scopus 로고
    • The point biserial coefficient of correlation
    • Lev, J. (1949). The point biserial coefficient of correlation. The Annals of Mathematical Statistics 20, 125-126.
    • (1949) The Annals of Mathematical Statistics , vol.20 , pp. 125-126
    • Lev, J.1
  • 11
    • 0035975996 scopus 로고    scopus 로고
    • Evaluation of surrogate endpoints in randomized experiments with mixed discrete and continuous outcomes
    • Molenberghs, G., Geys, H. and Buyse, M. (2001). Evaluation of surrogate endpoints in randomized experiments with mixed discrete and continuous outcomes. Statistics in Medicine 20, 3023-3038.
    • (2001) Statistics in Medicine , vol.20 , pp. 3023-3038
    • Molenberghs, G.1    Geys, H.2    Buyse, M.3
  • 13
    • 0002142826 scopus 로고
    • On a new method for determining the correlation between a measured character A, and a character B
    • Pearson, K. (1909). On a new method for determining the correlation between a measured character A, and a character B. Biometrika 7, 96-105.
    • (1909) Biometrika , vol.7 , pp. 96-105
    • Pearson, K.1
  • 15
    • 0024266392 scopus 로고    scopus 로고
    • Correlated binary regression with covariates specific to each binary observarion
    • Prentice, R. L. (1998). Correlated binary regression with covariates specific to each binary observarion. Biometrics 44, 1033-1048.
    • (1998) Biometrics , vol.44 , pp. 1033-1048
    • Prentice, R.L.1
  • 16
    • 53149101647 scopus 로고    scopus 로고
    • VALOR Trial Investigators. Nephrotoxicity of iodixanol versus ioversol in patients with chronic kidney disease: the Visipaque Angiography/Interventions with Laboratory Outcomes in Renal Insufficiency (VALOR) Trial
    • Rudnick, M. R., Davidson, C., Laskey, W., Stafford, J. L. and Sherwin, P. F. (2008). VALOR Trial Investigators. Nephrotoxicity of iodixanol versus ioversol in patients with chronic kidney disease: the Visipaque Angiography/Interventions with Laboratory Outcomes in Renal Insufficiency (VALOR) Trial. American Heart Journal 156, 776-782.
    • (2008) American Heart Journal , vol.156 , pp. 776-782
    • Rudnick, M.R.1    Davidson, C.2    Laskey, W.3    Stafford, J.L.4    Sherwin, P.F.5
  • 17
    • 58549097875 scopus 로고    scopus 로고
    • Sample size for simultaneous testing of rate differences in noninferiority trials with multiple endpoints
    • Song, J. X. (2009). Sample size for simultaneous testing of rate differences in noninferiority trials with multiple endpoints. Computational Statistics & Data Analysis 53, 1201-1207.
    • (2009) Computational Statistics & Data Analysis , vol.53 , pp. 1201-1207
    • Song, J.X.1
  • 18
    • 76149098065 scopus 로고    scopus 로고
    • Power and sample size calculations in clinical trials with multiple primary variables
    • Sozu, T., Kanou, T., Hamada, C. and Yoshimura, I. (2006). Power and sample size calculations in clinical trials with multiple primary variables. Japanese Journal of Biometrics 27, 83-96.
    • (2006) Japanese Journal of Biometrics , vol.27 , pp. 83-96
    • Sozu, T.1    Kanou, T.2    Hamada, C.3    Yoshimura, I.4
  • 19
    • 77956899112 scopus 로고    scopus 로고
    • Sample size determination in clinical trials with multiple co-primary binary endpoints
    • Sozu, T., Sugimoto, T. and Hamasaki, T. (2010). Sample size determination in clinical trials with multiple co-primary binary endpoints. Statistics in Medicine 29, 2169-2179.
    • (2010) Statistics in Medicine , vol.29 , pp. 2169-2179
    • Sozu, T.1    Sugimoto, T.2    Hamasaki, T.3
  • 20
    • 80052335270 scopus 로고    scopus 로고
    • Sample size determination in superiority clinical trials with multiple co-primary correlated endpoints
    • Sozu, T., Sugimoto, T. and Hamasaki, T. (2011). Sample size determination in superiority clinical trials with multiple co-primary correlated endpoints. Journal of Biopharmaceutical Statistics 21, 650-668.
    • (2011) Journal of Biopharmaceutical Statistics , vol.21 , pp. 650-668
    • Sozu, T.1    Sugimoto, T.2    Hamasaki, T.3
  • 21
    • 84858424146 scopus 로고    scopus 로고
    • A convenient formula for sample size calculations in clinical trials with multiple co-primary continuous endpoints
    • Sugimoto, T., Sozu, T. and Hamasaki, T. (2012). A convenient formula for sample size calculations in clinical trials with multiple co-primary continuous endpoints. Pharmaceutical Statistics 11, 118-128.
    • (2012) Pharmaceutical Statistics , vol.11 , pp. 118-128
    • Sugimoto, T.1    Sozu, T.2    Hamasaki, T.3
  • 22
    • 17244371152 scopus 로고
    • Correlation between a discrete and a continuous variable. Point-biserial correlation
    • Tate, R. F. (1954). Correlation between a discrete and a continuous variable. Point-biserial correlation. The Annals of Mathematical Statistics 25, 603-607.
    • (1954) The Annals of Mathematical Statistics , vol.25 , pp. 603-607
    • Tate, R.F.1
  • 23
    • 85050414571 scopus 로고
    • The theory of correlation between two continuous variable when one is dichotomized
    • Tate, R. F. (1955a). The theory of correlation between two continuous variable when one is dichotomized. Biometrika 42, 205-216.
    • (1955) Biometrika , vol.42 , pp. 205-216
    • Tate, R.F.1
  • 24
    • 26844481046 scopus 로고
    • Applications of correlation models for biserial data
    • Tate, R. F. (1955b). Applications of correlation models for biserial data. Journal of the American Statistical Association 50, 1078-1095.
    • (1955) Journal of the American Statistical Association , vol.50 , pp. 1078-1095
    • Tate, R.F.1
  • 25
    • 0005860269 scopus 로고
    • In defence of the arc sine approximation
    • Walters, D. E. (1979). In defence of the arc sine approximation. The Statistician 28, 219-222.
    • (1979) The Statistician , vol.28 , pp. 219-222
    • Walters, D.E.1
  • 26
    • 27744464827 scopus 로고    scopus 로고
    • Power and sample size for clinical trials when efficacy is required in multiple endpoints: application to an Alzheimer's treatment trial
    • Xiong, C., Yu, K., Gao, F., Yan, Y. and Zhang, Z. (2005). Power and sample size for clinical trials when efficacy is required in multiple endpoints: application to an Alzheimer's treatment trial. Clinical Trials 2, 387-393.
    • (2005) Clinical Trials , vol.2 , pp. 387-393
    • Xiong, C.1    Yu, K.2    Gao, F.3    Yan, Y.4    Zhang, Z.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.