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Volumn 29, Issue 14, 2010, Pages 1477-1487

Strength of evidence of non-inferiority trials - The adjustment of the type I error rate in non-inferiority trials with the synthesis method

Author keywords

Across trial type I error; Binary data; Correlation; Multivariate central limit theorem

Indexed keywords

NEW DRUG;

EID: 77953708859     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.3903     Document Type: Article
Times cited : (7)

References (14)
  • 1
    • 0037472837 scopus 로고    scopus 로고
    • Non-inferiority trials: Design concepts and issues - The encounters of academic consultants in statistics
    • D'Agostino RB, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics. Statistics in Medicine 2003; 22:169-186.
    • (2003) Statistics in Medicine , vol.22 , pp. 169-186
    • D'Agostino, R.B.1    Massaro, J.M.2    Sullivan, L.M.3
  • 2
    • 12244264188 scopus 로고    scopus 로고
    • Some fundamental issues with non-inferiority testing in active controlled trials
    • DOI 10.1002/sim.1315
    • Hung HM, Wang SJ, Tsong Y, Lawrence J, O'Neill R. Some fundamental issues for noninferiority testing in active controlled trials. Statistics in Medicine 2003; 22:213-225. (Pubitemid 36163582)
    • (2003) Statistics in Medicine , vol.22 , Issue.2 , pp. 213-225
    • Hung, H.M.J.1    Wang, S.-J.2    Tsong, Y.3    Lawrence, J.4    O'Neil, R.T.5
  • 3
    • 33947256217 scopus 로고    scopus 로고
    • The utility of active-controlled noninferiority/equivalence trials in drug development
    • Tsong Y. The utility of active-controlled noninferiority/equivalence trials in drug development. International Journal of Pharmaceutical Medicine 2007; 21(3):225-233.
    • (2007) International Journal of Pharmaceutical Medicine , vol.21 , Issue.3 , pp. 225-233
    • Tsong, Y.1
  • 4
    • 0032725063 scopus 로고    scopus 로고
    • Establishing equivalence by showing that a specified percentage of the effect of the active control over placebo is maintained
    • Holmgren EB. Establishing equivalence by showing that a specified percentage of the effect of the active control over placebo is maintained. Journal of Biopharmaceutical Statistics 1999; 9:651-659.
    • (1999) Journal of Biopharmaceutical Statistics , vol.9 , pp. 651-659
    • Holmgren, E.B.1
  • 5
    • 0035003536 scopus 로고    scopus 로고
    • Statistical methods for comparison to placebo in active-control trials
    • Hasselblad V, Kong D. Statistical methods for comparison to placebo in active-control trials. Drug Information Journal 2001; 35:435-449. (Pubitemid 32524896)
    • (2001) Drug Information Journal , vol.35 , Issue.2 , pp. 435-449
    • Hasselblad, V.1    Kong, D.F.2
  • 6
    • 0037472909 scopus 로고    scopus 로고
    • Design and analysis of non-inferiority mortality trials in oncology
    • DOI 10.1002/sim.1400
    • Rothmann M, Li N, Chen G, Temple R, Tsou R. Design and analysis of non-inferiority mortality trials in oncology. Statistics in Medicine 2003; 22:239-264. (Pubitemid 36163584)
    • (2003) Statistics in Medicine , vol.22 , Issue.2 , pp. 239-264
    • Rothmann, M.1    Li, N.2    Chen, G.3    Chi, G.Y.H.4    Temple, R.5    Tsou, H.-H.6
  • 7
    • 2642576574 scopus 로고    scopus 로고
    • Alternatives for discounting in the analysis of noninferiority trials
    • DOI 10.1081/BIP-120037178
    • Snapinn SM. Alternatives for discounting in the analysis of non-inferiority trials. Journal of Biopharmaceutical Statistics 2004; 14:263-273. (Pubitemid 38715780)
    • (2004) Journal of Biopharmaceutical Statistics , vol.14 , Issue.2 , pp. 263-273
    • Snapinn, S.M.1
  • 8
    • 0037285074 scopus 로고    scopus 로고
    • Statistical issues on objective, design, and analysis of noninferiority active-controlled clinical trial
    • DOI 10.1081/BIP-120017724
    • Tsong Y, Wang SJ, Hung HM. Statistical issues on objective, design and analysis of noninferiority active-controlled clinical trial. Journal of Biopharmaceutical Statistics 2003; 13:29-41. (Pubitemid 36254361)
    • (2003) Journal of Biopharmaceutical Statistics , vol.13 , Issue.1 , pp. 29-41
    • Tsong, Y.1    Wang, S.J.2    Hung, H.M.J.3    Cui, L.4
  • 9
    • 39449121330 scopus 로고    scopus 로고
    • Choice of λ-margin and dependency of non-inferiority trials
    • DOI 10.1002/sim.2988
    • Tsong Y, Levenson M, Zhang J, Zhong J. Choice of λ-margin and dependency of non-inferiority trials. Statistics in Medicine 2008; 27:520-528. (Pubitemid 351266339)
    • (2008) Statistics in Medicine , vol.27 , Issue.4 , pp. 520-528
    • Tsong, Y.1    Levenson, M.2    Zhang, J.3    Zhong, J.4
  • 10
    • 33947221619 scopus 로고    scopus 로고
    • Issues with statistical risks for testing methods in noninferiority trial without a placebo arm
    • DOI 10.1080/10543400601177343, PII 773167072
    • Hung HM, Wang SJ, O'Neill R. Issues with statistical risks for testing methods in non-inferiority trial without a placebo arm. Journal of Biopharmaceutical Statistics 2007; 17:201-213. (Pubitemid 46423595)
    • (2007) Journal of Biopharmaceutical Statistics , vol.17 , Issue.2 , pp. 201-213
    • Hung, H.M.J.1    Wang, S.-J.2    O'Neill, R.3
  • 12
    • 66349086534 scopus 로고    scopus 로고
    • Challenges and regulatory experiences with non-inferiority trial design without placebo arm
    • Hung HM, Wang SJ, O'Neill R. Challenges and regulatory experiences with non-inferiority trial design without placebo arm. Biometrical Journal 2009; 51(2):324-334.
    • (2009) Biometrical Journal , vol.51 , Issue.2 , pp. 324-334
    • Hung, H.M.1    Wang, S.J.2    O'Neill, R.3
  • 13
    • 0036174142 scopus 로고    scopus 로고
    • Utility and pitfalls of some statistical methods in active controlled clinical trials
    • DOI 10.1016/S0197-2456(01)00155-6, PII S0197245601001556
    • Wang SJ, Hung HM, Tsong Y. Utility and pitfalls of some statistical methods in an active controlled trials. Controlled Clinical Trials 2002; 23:15-28. (Pubitemid 34164355)
    • (2002) Controlled Clinical Trials , vol.23 , Issue.1 , pp. 15-28
    • Wang, S.-J.1    Hung, H.M.J.2    Tsong, Y.3
  • 14
    • 33947217460 scopus 로고    scopus 로고
    • Choice of δ noninferiority margin and dependency of the noninferiority trials
    • Tsong Y, Zhang J, Levenson M. Choice of δ noninferiority margin and dependency of the noninferiority trials. Journal of Biopharmaceutical Statistics 2007; 17:279-288.
    • (2007) Journal of Biopharmaceutical Statistics , vol.17 , pp. 279-288
    • Tsong, Y.1    Zhang, J.2    Levenson, M.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.