메뉴 건너뛰기




Volumn 23, Issue 4, 2013, Pages 774-789

Three-arm noninferiority trials with a prespecified margin for inference of the difference in the proportions of binary endpoints

Author keywords

Assay sensitivity; Binary endpoint; Optimal allocation; Prespecified noninferiority margin; Three arm noninferiority

Indexed keywords

DULOXETINE; PAROXETINE; PLACEBO;

EID: 84881302277     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543406.2013.789893     Document Type: Article
Times cited : (14)

References (26)
  • 1
    • 0037472837 scopus 로고    scopus 로고
    • Noninferiority trials: Design concepts and issues-The encounters of academic consultants in statistics
    • DOI: 10.1002/sim.1425
    • D'Agostino, R. B., Massaro, J. M., Sullivan, L. M. (2003). Noninferiority trials: Design concepts and issues-The encounters of academic consultants in statistics. Statistics in Medicine 22:169-186. DOI: 10.1002/sim.1425
    • (2003) Statistics in Medicine , vol.22 , pp. 169-186
    • D'Agostino, R.B.1    Massaro, J.M.2    Sullivan, L.M.3
  • 2
    • 33745718839 scopus 로고    scopus 로고
    • European Medicines Agency. (Doc Ref. EMEA/CPMP/EWP/2158/99
    • European Medicines Agency. (2005). Guideline on the choice of the noninferiority margin (Doc. Ref. EMEA/CPMP/EWP/2158/99). http://www.ema.europa. eu/docs/enGB/documentlibrary/Scientificguideline/2009/09/WC500003636.pdf (31 August 2011).
    • (2005) Guideline on the Choice of the Noninferiority Margin
  • 3
    • 84881288503 scopus 로고    scopus 로고
    • Food and Drug Administration Guidance for Industry Noninferiority Clinical Trials. (2010)
    • Food and Drug Administration Guidance for Industry Noninferiority Clinical Trials. (2010). http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf (31 August 2011).
  • 4
    • 0025633361 scopus 로고
    • Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or nonunity relative risk
    • Frarrington, C. P., Manning, G. (1990). Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or nonunity relative risk. Statistics in Medicine 9:1447-1454.
    • (1990) Statistics in Medicine , vol.9 , pp. 1447-1454
    • Frarrington, C.P.1    Manning, G.2
  • 5
    • 39449129871 scopus 로고    scopus 로고
    • Assessing noninferiority of a new treatment in a three-arm trial in the presence of heteroscedasticity
    • Hasler, M., Vonk, R., Hothorn, L. A. (2008). Assessing noninferiority of a new treatment in a three-arm trial in the presence of heteroscedasticity. Statistics in Medicine 27:490-503.
    • (2008) Statistics in Medicine , vol.27 , pp. 490-503
    • Hasler, M.1    Vonk, R.2    Hothorn, L.A.3
  • 6
    • 78650942468 scopus 로고    scopus 로고
    • On the three-arm noninferiority trial including a placebo with a prespecified margin
    • Hida, E., Tango, T. (2011). On the three-arm noninferiority trial including a placebo with a prespecified margin. Statistics in Medicine 30:224-231.
    • (2011) Statistics in Medicine , vol.30 , pp. 224-231
    • Hida, E.1    Tango, T.2
  • 7
    • 78650925915 scopus 로고    scopus 로고
    • Clinical evaluation of duloxetine in the treatment of major depressive disorder-Placebo-and paroxetine-controlled doubleblind comparative study
    • Higuchi, T., Murasaki, M., Kamijima, K. (2009). Clinical evaluation of duloxetine in the treatment of major depressive disorder-Placebo-and paroxetine-controlled doubleblind comparative study. Japan Journal of Clinical Psychopharmacology 12:1613-1634.
    • (2009) Japan Journal of Clinical Psychopharmacology , vol.12 , pp. 1613-1634
    • Higuchi, T.1    Murasaki, M.2    Kamijima, K.3
  • 10
    • 33846191097 scopus 로고    scopus 로고
    • Planning and analysis of three-arm noninferiority trials with binary endpoints
    • Kieser, M., Friede, T. (2007). Planning and analysis of three-arm noninferiority trials with binary endpoints. Statistics in Medicine 26:253-273.
    • (2007) Statistics in Medicine , vol.26 , pp. 253-273
    • Kieser, M.1    Friede, T.2
  • 11
    • 2642585618 scopus 로고    scopus 로고
    • Hypothesis testing in the 'gold standard' design for proving the efficacy of an experimental treatment relative to placebo and a reference
    • Koch, A., Röhmel, J. (2004). Hypothesis testing in the 'gold standard' design for proving the efficacy of an experimental treatment relative to placebo and a reference. Journal of Biopharmaceutical Statistics 14:315-325.
    • (2004) Journal of Biopharmaceutical Statistics , vol.14 , pp. 315-325
    • Koch, A.1    Röhmel, J.2
  • 12
    • 0032716231 scopus 로고    scopus 로고
    • Nonparametric analysis of covariance and its role in noninferiority clinical trials
    • Koch, G. G., Tangen, C. M. (1999). Nonparametric analysis of covariance and its role in noninferiority clinical trials. Drug Information Journal 33:1145-1159.
    • (1999) Drug Information Journal , vol.33 , pp. 1145-1159
    • Koch, G.G.1    Tangen, C.M.2
  • 14
    • 77956295377 scopus 로고    scopus 로고
    • A group sequential type design for three-arm-noninferiority trials with binary endpoints
    • Li, G., Gao, S. (2010). A group sequential type design for three-arm-noninferiority trials with binary endpoints. Biometrical Journal 52:504-518.
    • (2010) Biometrical Journal , vol.52 , pp. 504-518
    • Li, G.1    Gao, S.2
  • 15
    • 60249095140 scopus 로고    scopus 로고
    • The assessment of noninferiority in a gold standard design with censored, exponentially distributed endpoints
    • Mielke, M., Munk, A., Schacht, A. (2008). The assessment of noninferiority in a gold standard design with censored, exponentially distributed endpoints. Statistics in Medicine 27:5093-5110.
    • (2008) Statistics in Medicine , vol.27 , pp. 5093-5110
    • Mielke, M.1    Munk, A.2    Schacht, A.3
  • 16
    • 72849146423 scopus 로고    scopus 로고
    • Nonparametric noninferiority analyses in the three-arm design with active control and placebo
    • doi: 10.1002/sim.3727
    • Munzel, U. (2009). Nonparametric noninferiority analyses in the three-arm design with active control and placebo. Statistics in Medicine 28:3643-3656. doi:10.1002/sim.3727
    • (2009) Statistics in Medicine , vol.28 , pp. 3643-3656
    • Munzel, U.1
  • 17
    • 59449099750 scopus 로고    scopus 로고
    • Noninferiority hypotheses and choice of noninferiority margin
    • Ng, T.-H. (2008). Noninferiority hypotheses and choice of noninferiority margin. Statistics in Medicine 27:5392-5406.
    • (2008) Statistics in Medicine , vol.27 , pp. 5392-5406
    • Ng, T.-H.1
  • 18
    • 0033378990 scopus 로고
    • Evolution of remission as the new standard in the treatment of depression
    • Nierenberg, A. A., Wright, E. C. (1990). Evolution of remission as the new standard in the treatment of depression. Journal of Clinical Psychiatry 60:7-11.
    • (1990) Journal of Clinical Psychiatry , vol.60 , pp. 7-11
    • Nierenberg, A.A.1    Wright, E.C.2
  • 19
    • 0037473218 scopus 로고    scopus 로고
    • Assessing noninferiority of a new treatment in a three-arm clinical trial including a placebo
    • Pigeot, I., Schäfer, J., Röhmel, J., Hauschke, D. (2003). Assessing noninferiority of a new treatment in a three-arm clinical trial including a placebo. Statistics in Medicine 22:883-899.
    • (2003) Statistics in Medicine , vol.22 , pp. 883-899
    • Pigeot, I.1    Schäfer, J.2    Röhmel, J.3    Hauschke, D.4
  • 20
    • 15244359938 scopus 로고    scopus 로고
    • Problems with existing procedures to calculate exact unconditional p-values for noninferiority/superiority and confidence intervals for two binomials and how to resolve them
    • Röhmel, J. (2005a). Problems with existing procedures to calculate exact unconditional p-values for noninferiority/superiority and confidence intervals for two binomials and how to resolve them. Biometrical Journal 47:37-47.
    • (2005) Biometrical Journal , vol.47 , pp. 37-47
    • Röhmel, J.1
  • 21
    • 29844456173 scopus 로고    scopus 로고
    • On confidence bounds for the ratio of net differences in the gold standard design with reference, experimental, and placebo treatment
    • Röhmel, J. (2005b). On confidence bounds for the ratio of net differences in the gold standard design with reference, experimental, and placebo treatment. Biometrical Journal 47:799-806.
    • (2005) Biometrical Journal , vol.47 , pp. 799-806
    • Röhmel, J.1
  • 22
    • 77955904711 scopus 로고    scopus 로고
    • A comparison of multiple testing procedures for the gold standard noninferiority trial
    • Röhmel, J., Pigeot, I. (2010). A comparison of multiple testing procedures for the gold standard noninferiority trial. Journal of Biopharmaceutical Statistics 20:911-926.
    • (2010) Journal of Biopharmaceutical Statistics , vol.20 , pp. 911-926
    • Röhmel, J.1    Pigeot, I.2
  • 23
    • 0030029106 scopus 로고    scopus 로고
    • 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
    • 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.
    • (1996) Statistics in Medicine , vol.15 , pp. 1-21
    • Sahai, H.1    Khurshid, A.2
  • 25
    • 2642569237 scopus 로고    scopus 로고
    • Tests of noninferiority via rate difference for three-arm clinical trials with placebo
    • Tang, M. L., Tang, N. S. (2004). Tests of noninferiority via rate difference for three-arm clinical trials with placebo. Journal of Biopharmaceutical Statistics 14:337-347.
    • (2004) Journal of Biopharmaceutical Statistics , vol.14 , pp. 337-347
    • Tang, M.L.1    Tang, N.S.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.