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Volumn 29, Issue 7-8, 2010, Pages 743-759

Optimal group-sequential designs for simultaneous testing of superiority and non-inferiority

Author keywords

Adaptive re design; Clinical trial; Decision theory; Group sequential test; Non inferiority; Superiority

Indexed keywords

ARTICLE; CALCULATION; CLINICAL STUDY; MATHEMATICAL PARAMETERS; QUANTITATIVE STUDY; SEQUENTIAL ANALYSIS; SIMULATION;

EID: 77949409796     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.3790     Document Type: Article
Times cited : (13)

References (24)
  • 1
    • 0028807804 scopus 로고
    • A useful testing strategy in phase III trials: Combined test of superiority and test of equivalence
    • Morikawa T, Yoshida M. A useful testing strategy in phase III trials: combined test of superiority and test of equivalence. Journal of Biopharmaceutical Statistics 1995; 5:297-306.
    • (1995) Journal of Biopharmaceutical Statistics , vol.5 , pp. 297-306
    • Morikawa, T.1    Yoshida, M.2
  • 2
    • 0035879641 scopus 로고    scopus 로고
    • Group sequential test strategies for superiority and non-inferiority hypotheses in active controlled clinical trials
    • Wang SJ, Hung HMJ, Tsong Y, Cui L. Group sequential test strategies for superiority and non-inferiority hypotheses in active controlled clinical trials. Statistics in Medicine 2001; 20:1903-1912.
    • (2001) Statistics in Medicine , vol.20 , pp. 1903-1912
    • Wang, S.J.1    Hung, H.M.J.2    Tsong, Y.3    Cui, L.4
  • 3
    • 0032886394 scopus 로고    scopus 로고
    • Modification of sample size in group sequential trials
    • Cui L, Hung H, Wang S. Modification of sample size in group sequential trials. Biometrics 1999; 55:853-857.
    • (1999) Biometrics , vol.55 , pp. 853-857
    • Cui, L.1    Hung, H.2    Wang, S.3
  • 4
    • 4444345588 scopus 로고    scopus 로고
    • Two-stage adaptive strategy for superiority and non-inferiority hypotheses in active controlled clinical trials
    • Shih WJ, Quan H, Li G. Two-stage adaptive strategy for superiority and non-inferiority hypotheses in active controlled clinical trials. Statistics in Medicine 2004; 23:2781-2798.
    • (2004) Statistics in Medicine , vol.23 , pp. 2781-2798
    • Shih, W.J.1    Quan, H.2    Li, G.3
  • 5
    • 23244448022 scopus 로고    scopus 로고
    • A framework for two-stage adaptive procedures to simultaneously test non-inferiority and superiority
    • Koyama T, Sampson AR, Gleser LJ. A framework for two-stage adaptive procedures to simultaneously test non-inferiority and superiority. Statistics in Medicine 2005; 24:2439-2456.
    • (2005) Statistics in Medicine , vol.24 , pp. 2439-2456
    • Koyama, T.1    Sampson, A.R.2    Gleser, L.J.3
  • 6
    • 33645469337 scopus 로고    scopus 로고
    • Modified Haybittle-Peto group sequential designs for testing superiority and non-inferiority hypotheses in clinical trials
    • Lai TL, Shih MC, Zhu G. Modified Haybittle-Peto group sequential designs for testing superiority and non-inferiority hypotheses in clinical trials. Statistics in Medicine 2006; 25:1149-1167.
    • (2006) Statistics in Medicine , vol.25 , pp. 1149-1167
    • Lai, T.L.1    Shih, M.C.2    Zhu, G.3
  • 7
    • 33644973601 scopus 로고    scopus 로고
    • Adaptive and nonadaptive group sequential tests
    • Jennison C, Turnbull BW. Adaptive and nonadaptive group sequential tests. Biometrika 2006; 93:1-21.
    • (2006) Biometrika , vol.93 , pp. 1-21
    • Jennison, C.1    Turnbull, B.W.2
  • 8
    • 77949381808 scopus 로고    scopus 로고
    • 3-decision rules useful for assessing superiority or equivalence
    • Memphis, TN
    • Gould AL. 3-decision rules useful for assessing superiority or equivalence. Enar Biometrics Society, Memphis, TN, 1997.
    • (1997) Enar Biometrics Society
    • Gould, A.L.1
  • 10
    • 0040235596 scopus 로고
    • An improved method for deriving optimal one-sided group sequential tests
    • Eales JD, Jennison C. An improved method for deriving optimal one-sided group sequential tests. Biometrika 1992; 79:13-24.
    • (1992) Biometrika , vol.79 , pp. 13-24
    • Eales, J.D.1    Jennison, C.2
  • 11
    • 4444252560 scopus 로고
    • Optimal two-sided group sequential tests
    • Eales JD, Jennison C. Optimal two-sided group sequential tests. Sequential Analysis 1995; 14:273-286.
    • (1995) Sequential Analysis , vol.14 , pp. 273-286
    • Eales, J.D.1    Jennison, C.2
  • 12
    • 0012447357 scopus 로고    scopus 로고
    • Optimal asymmetric one-sided group sequential tests
    • Barber S, Jennison C. Optimal asymmetric one-sided group sequential tests. Biometrika 2002; 89:49-60.
    • (2002) Biometrika , vol.89 , pp. 49-60
    • Barber, S.1    Jennison, C.2
  • 14
    • 70449529019 scopus 로고
    • Discrete sequential boundaries for clinical trials
    • Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70:659-663.
    • (1983) Biometrika , vol.70 , pp. 659-663
    • Lan, K.K.G.1    DeMets, D.L.2
  • 15
    • 33644770078 scopus 로고    scopus 로고
    • Efficient group sequential designs when there are several effect sizes under consideration
    • Jennison C, Turnbull BW. Efficient group sequential designs when there are several effect sizes under consideration. Statistics in Medicine 2006; 25:917-932.
    • (2006) Statistics in Medicine , vol.25 , pp. 917-932
    • Jennison, C.1    Turnbull, B.W.2
  • 16
    • 0037366620 scopus 로고    scopus 로고
    • Sequential tests for noninferiority and superiority
    • Brannath W, Bauer P, Maurer W, Posch M. Sequential tests for noninferiority and superiority. Biometrics 2003; 59:106-114.
    • (2003) Biometrics , vol.59 , pp. 106-114
    • Brannath, W.1    Bauer, P.2    Maurer, W.3    Posch, M.4
  • 17
    • 0018687930 scopus 로고
    • A multiple testing procedure for clinical trials
    • O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979; 35:549-556.
    • (1979) Biometrics , vol.35 , pp. 549-556
    • O'Brien, P.C.1    Fleming, T.R.2
  • 18
    • 0017744944 scopus 로고
    • Group sequential methods in the design and analysis of clinical trials
    • Pocock SJ. Group sequential methods in the design and analysis of clinical trials. Biometrika 1977; 64:191-199.
    • (1977) Biometrika , vol.64 , pp. 191-199
    • Pocock, S.J.1
  • 19
    • 0035739842 scopus 로고    scopus 로고
    • Flexible sample size considerations using information-based interim monitoring
    • Mehta CR, Tsiatis AA. Flexible sample size considerations using information-based interim monitoring. Drug Information Journal 2001; 35:1095-1112.
    • (2001) Drug Information Journal , vol.35 , pp. 1095-1112
    • Mehta, C.R.1    Tsiatis, A.A.2
  • 20
    • 0039090984 scopus 로고
    • Optimal Sequentially Planned Decision Procedures
    • Springer: New York
    • Schmitz N. Optimal Sequentially Planned Decision Procedures. Lecture Notes in Statistics, vol. 79. Springer: New York, 1993.
    • (1993) Lecture Notes in Statistics , vol.79
    • Schmitz, N.1
  • 21
    • 77949347610 scopus 로고    scopus 로고
    • EMEA note for guidance on clinical investigation of medicinal products of diabetes mellitus. Available from:, 14 September 2009
    • EMEA note for guidance on clinical investigation of medicinal products of diabetes mellitus. Available from: http://www.emea.europa.eu/pdfs/human/ewp/ 108000en.pdf [14 September 2009].
  • 23
    • 34948858370 scopus 로고    scopus 로고
    • The effect of tesaglitazar as add-on treatment to metformin in patients with poorly controlled type 2 diabetes
    • Göke B, Gausse-Nilsson I, Persson A. The effect of tesaglitazar as add-on treatment to metformin in patients with poorly controlled type 2 diabetes. Diabetes and Vascular Disease Research 2007; 4:204-213.
    • (2007) Diabetes and Vascular Disease Research , vol.4 , pp. 204-213
    • Göke, B.1    Gausse-Nilsson, I.2    Persson, A.3
  • 24
    • 0037473229 scopus 로고    scopus 로고
    • Mid-course sample size modification in clinical trials based on the observed treatment effect
    • Jennison C, Turnbull BW. Mid-course sample size modification in clinical trials based on the observed treatment effect. Statistics in Medicine 2003; 22:971-993.
    • (2003) Statistics in Medicine , vol.22 , pp. 971-993
    • Jennison, C.1    Turnbull, B.W.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.