메뉴 건너뛰기




Volumn 33, Issue 17, 2014, Pages 2897-2913

Sample size determination in group-sequential clinical trials with two co-primary endpoints

Author keywords

Average sample number; Co primary endpoints; Conditional power; Cui Hung Wang statistics; Group sequential methods; Maximum sample size; Sample size recalculation; Type I error

Indexed keywords

ARTICLE; AVERAGING; CALCULATION; CLINICAL TRIAL (TOPIC); CONTROLLED STUDY; DATA ANALYSIS; DECISION MAKING; EFFECT SIZE; MATHEMATICAL COMPUTING; SAMPLE SIZE; SIMULATION; STATISTICAL SIGNIFICANCE; ALZHEIMER DISEASE; COGNITION; DAILY LIFE ACTIVITY; DRUG EFFECTS; HUMAN; METHODOLOGY; PATHOPHYSIOLOGY; PROCEDURES; STATISTICAL MODEL; TREATMENT OUTCOME;

EID: 84903817449     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.6154     Document Type: Article
Times cited : (22)

References (33)
  • 3
    • 60749125498 scopus 로고    scopus 로고
    • Some controversial multiple testing problems in regulatory applications
    • DOI: 10.1080/10543400802541693.
    • Hung HMJ, Wang SJ. Some controversial multiple testing problems in regulatory applications. Journal of Biopharmaceutical Statistics 2009; 19:1-11. DOI: 10.1080/10543400802541693.
    • (2009) Journal of Biopharmaceutical Statistics , vol.19 , pp. 1-11
    • Hung, H.M.J.1    Wang, S.J.2
  • 5
    • 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
    • DOI: 10.1191/1740774505cn112oa.
    • Xiong C, Yu K, Gao F, Yan Y, Zhang Z. Power and sample size for clinical trials when efficacy is required in multiple endpoints: application to an Alzheimer's treatment trial. Clinical Trials 2005; 2:387-393. DOI: 10.1191/1740774505cn112oa.
    • (2005) Clinical Trials , vol.2 , pp. 387-393
    • Xiong, C.1    Yu, K.2    Gao, F.3    Yan, Y.4    Zhang, Z.5
  • 6
    • 76149098065 scopus 로고    scopus 로고
    • Power and sample size calculations in clinical trials with multiple primary variables
    • DOI: 10.5691/jjb.27.83.
    • Sozu T, Kanou T, Hamada C, Yoshimura I. Power and sample size calculations in clinical trials with multiple primary variables. Japanese Journal of Biometrics 2006; 27:83-96. DOI: 10.5691/jjb.27.83.
    • (2006) Japanese Journal of Biometrics , vol.27 , pp. 83-96
    • Sozu, T.1    Kanou, T.2    Hamada, C.3    Yoshimura, I.4
  • 7
    • 33847698947 scopus 로고    scopus 로고
    • Challenge of multiple co-primary endpoints: a new approach
    • DOI: 10.1002/sim.2604.
    • Chuang-Stein C, Stryszak P, Dmitrienko A, Offen W. Challenge of multiple co-primary endpoints: a new approach. Statistics in Medicine 2007; 26:1181-1192. DOI: 10.1002/sim.2604.
    • (2007) Statistics in Medicine , vol.26 , pp. 1181-1192
    • Chuang-Stein, C.1    Stryszak, P.2    Dmitrienko, A.3    Offen, W.4
  • 8
    • 34447524798 scopus 로고    scopus 로고
    • On multiple endpoints testing problem
    • DOI: 10.1016/j.jspi.2007.03.021.
    • Eaton ML, Muirhead RJ. On multiple endpoints testing problem. Journal of Statistical Planning & Inference 2007; 137:3416-3429. DOI: 10.1016/j.jspi.2007.03.021.
    • (2007) Journal of Statistical Planning & Inference , vol.137 , pp. 3416-3429
    • Eaton, M.L.1    Muirhead, R.J.2
  • 9
    • 34648823148 scopus 로고    scopus 로고
    • Power and sample size when multiple endpoints are considered
    • DOI: 10.1002/pst.301.
    • Senn S, Bretz F. Power and sample size when multiple endpoints are considered. Pharmaceutical Statistics 2007; 6:161-170. DOI: 10.1002/pst.301.
    • (2007) Pharmaceutical Statistics , vol.6 , pp. 161-170
    • Senn, S.1    Bretz, F.2
  • 10
    • 77955734898 scopus 로고    scopus 로고
    • Method of balanced adjustment in testing co-primary endpoints
    • DOI: 10.1002/sim.3950.
    • Kordzakhia G, Siddiqui O, Huque MF. Method of balanced adjustment in testing co-primary endpoints. Statistics in Medicine 2010; 29:2055-2066. DOI: 10.1002/sim.3950.
    • (2010) Statistics in Medicine , vol.29 , pp. 2055-2066
    • Kordzakhia, G.1    Siddiqui, O.2    Huque, M.F.3
  • 11
    • 77956899112 scopus 로고    scopus 로고
    • Sample size determination in clinical trials with multiple co-primary binary endpoints
    • DOI: 10.1002/sim.3972.
    • Sozu T, Sugimoto T, Hamasaki T. Sample size determination in clinical trials with multiple co-primary binary endpoints. Statistics in Medicine 2010; 29:2169-2179. DOI: 10.1002/sim.3972.
    • (2010) Statistics in Medicine , vol.29 , pp. 2169-2179
    • Sozu, T.1    Sugimoto, T.2    Hamasaki, T.3
  • 12
    • 80052335270 scopus 로고    scopus 로고
    • Sample size determination in superiority clinical trials with multiple co-primary correlated endpoints
    • DOI: 10.1080/10543406.2011.551329.
    • Sozu T, Sugimoto T, Hamasaki T. Sample size determination in superiority clinical trials with multiple co-primary correlated endpoints. Journal of Biopharmaceutical Statistics 2011; 21:650-668. DOI: 10.1080/10543406.2011.551329.
    • (2011) Journal of Biopharmaceutical Statistics , vol.21 , pp. 650-668
    • Sozu, T.1    Sugimoto, T.2    Hamasaki, T.3
  • 13
    • 84858437513 scopus 로고    scopus 로고
    • Sample sizes for trials involving multiple correlated must-win comparisons
    • DOI: 10.1002/pst.515.
    • Julious S, Mclntyre NE. Sample sizes for trials involving multiple correlated must-win comparisons. Pharmaceutical Statistics 2012; 11:177-185. DOI: 10.1002/pst.515.
    • (2012) Pharmaceutical Statistics , vol.11 , pp. 177-185
    • Julious, S.1    Mclntyre, N.E.2
  • 14
    • 84858424146 scopus 로고    scopus 로고
    • A convenient formula for sample size calculations in clinical trials with multiple co-primary continuous endpoints
    • DOI: 10.1002/pst.505.
    • Sugimoto T, Sozu T, Hamasaki T. A convenient formula for sample size calculations in clinical trials with multiple co-primary continuous endpoints. Pharmaceutical Statistics 2012; 11:118-128. DOI: 10.1002/pst.505.
    • (2012) Pharmaceutical Statistics , vol.11 , pp. 118-128
    • Sugimoto, T.1    Sozu, T.2    Hamasaki, T.3
  • 15
    • 84872494740 scopus 로고    scopus 로고
    • Sample size determination for clinical trials with co-primary outcomes: exponential event times
    • DOI: 10.1002/pst.1545.
    • Hamasaki T, Sugimoto T, Evans SR, Sozu T. Sample size determination for clinical trials with co-primary outcomes: exponential event times. Pharmaceutical Statistics 2013; 12:28-34. DOI: 10.1002/pst.1545.
    • (2013) Pharmaceutical Statistics , vol.12 , pp. 28-34
    • Hamasaki, T.1    Sugimoto, T.2    Evans, S.R.3    Sozu, T.4
  • 16
    • 84879101578 scopus 로고    scopus 로고
    • A logrank test-based method for sizing clinical trials with two co-primary time-to-event endpoints
    • DOI: 10.1093/biostatistics/kxs057.
    • Sugimoto T, Sozu T, Hamasaki T, Evans SR. A logrank test-based method for sizing clinical trials with two co-primary time-to-event endpoints. Biostatistics 2013; 14:409-421. DOI: 10.1093/biostatistics/kxs057.
    • (2013) Biostatistics , vol.14 , pp. 409-421
    • Sugimoto, T.1    Sozu, T.2    Hamasaki, T.3    Evans, S.R.4
  • 17
    • 70449529019 scopus 로고
    • Discrete sequential boundaries for clinical trials
    • DOI: 10.1093/biomet/70.3.659.
    • Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70:659-663. DOI: 10.1093/biomet/70.3.659.
    • (1983) Biometrika , vol.70 , pp. 659-663
    • Lan, K.K.G.1    DeMets, D.L.2
  • 18
    • 0018687930 scopus 로고
    • A multiple testing procedure for clinical trials
    • DOI: 10.2307/2530245.
    • O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979; 35:549-556. DOI: 10.2307/2530245.
    • (1979) Biometrics , vol.35 , pp. 549-556
    • O'Brien, P.C.1    Fleming, T.R.2
  • 19
    • 0017744944 scopus 로고
    • Group sequential methods in the design and analysis of clinical trials
    • DOI: 10.1093/biomet/64.2.191.
    • Pocock SJ. Group sequential methods in the design and analysis of clinical trials. Biometrika 1977; 64:191-199. DOI: 10.1093/biomet/64.2.191.
    • (1977) Biometrika , vol.64 , pp. 191-199
    • Pocock, S.J.1
  • 20
    • 74749107462 scopus 로고    scopus 로고
    • Hierarchical testing of multiple endpoints in group-sequential trials
    • DOI: 10.1002/sim.3748.
    • Glimm E, Maurer W, Bretz F. Hierarchical testing of multiple endpoints in group-sequential trials. Statistics in Medicine 2010; 29:219-228. DOI: 10.1002/sim.3748.
    • (2010) Statistics in Medicine , vol.29 , pp. 219-228
    • Glimm, E.1    Maurer, W.2    Bretz, F.3
  • 21
    • 78650040507 scopus 로고    scopus 로고
    • Testing a primary and secondary endpoint in a group sequential design
    • DOI: 10.1111/j.1541-0420.2010.01402.x.
    • Tamhane AC, Mehta CR, Liu L. Testing a primary and secondary endpoint in a group sequential design. Biometrics 2010; 66:1174-1184. DOI: 10.1111/j.1541-0420.2010.01402.x.
    • (2010) Biometrics , vol.66 , pp. 1174-1184
    • Tamhane, A.C.1    Mehta, C.R.2    Liu, L.3
  • 22
    • 72549105935 scopus 로고    scopus 로고
    • Effect of tarenflurbil on cognitive decline and activities of daily living in patients with mild Alzheimer disease: a randomized controlled trial
    • for the Tarenflurbil Phase 3 Study Group. DOI: 10.1001/jama.2009.1866.
    • Green RC, Schneider LS, Amato DA, Beelen AP, Wilcock G, Swabb EA, Zavitz KH, for the Tarenflurbil Phase 3 Study Group. Effect of tarenflurbil on cognitive decline and activities of daily living in patients with mild Alzheimer disease: a randomized controlled trial. Journal of the American Medical Association 2009; 302:2557-2564. DOI: 10.1001/jama.2009.1866.
    • (2009) Journal of the American Medical Association , vol.302 , pp. 2557-2564
    • Green, R.C.1    Schneider, L.S.2    Amato, D.A.3    Beelen, A.P.4    Wilcock, G.5    Swabb, E.A.6    Zavitz, K.H.7
  • 23
    • 0030837745 scopus 로고    scopus 로고
    • The Alzheimer's disease assessment scale: patterns and predictors of baseline cognitive performance in multicenter Alzheimer's disease trials
    • DOI: 10.1212/WNL.48.6.1511.
    • Doraiswamy PM, Bieber F, Kaiser L, Krishnan KR, Reuning-Scherer J, Gulanski B. The Alzheimer's disease assessment scale: patterns and predictors of baseline cognitive performance in multicenter Alzheimer's disease trials. Neurology 1997; 48:1511-1517. DOI: 10.1212/WNL.48.6.1511.
    • (1997) Neurology , vol.48 , pp. 1511-1517
    • Doraiswamy, P.M.1    Bieber, F.2    Kaiser, L.3    Krishnan, K.R.4    Reuning-Scherer, J.5    Gulanski, B.6
  • 24
    • 0032886394 scopus 로고    scopus 로고
    • Modification of sample size in group sequential clinical trials
    • DOI: 10.1111/j.0006-341X.1999.00853.x.
    • Cui L, Hung HMJ, Wang SJ. Modification of sample size in group sequential clinical trials. Biometrics 1999; 55:853-857. DOI: 10.1111/j.0006-341X.1999.00853.x.
    • (1999) Biometrics , vol.55 , pp. 853-857
    • Cui, L.1    Hung, H.M.J.2    Wang, S.J.3
  • 28
    • 33751196148 scopus 로고    scopus 로고
    • Dependence, hyper-dependence and hypothesis testing in clinical trials
    • DOI: 10.1016/j.cct.2006.05.010.
    • Moyé LA, Baraniuk S. Dependence, hyper-dependence and hypothesis testing in clinical trials. Contemporary Clinical Trials 2013; 28:68-78. DOI: 10.1016/j.cct.2006.05.010.
    • (2013) Contemporary Clinical Trials , vol.28 , pp. 68-78
    • Moyé, L.A.1    Baraniuk, S.2
  • 29
    • 0027425644 scopus 로고
    • Group sequential tests for bivariate response: interim analyses of clinical trials with both efficacy and safety
    • Jennison C, Turnbull BW. Group sequential tests for bivariate response: interim analyses of clinical trials with both efficacy and safety. Biometrics 1993; 49:741-752.
    • (1993) Biometrics , vol.49 , pp. 741-752
    • Jennison, C.1    Turnbull, B.W.2
  • 30
    • 0032714063 scopus 로고    scopus 로고
    • Closed testing procedures for group sequential clinical trials with multiple endpoints
    • DOI: 10.1111/j.0006-341X.1999.01188.x.
    • Tang DI, Geller NL. Closed testing procedures for group sequential clinical trials with multiple endpoints. Biometrics 1999; 55:1188-1192. DOI: 10.1111/j.0006-341X.1999.01188.x.
    • (1999) Biometrics , vol.55 , pp. 1188-1192
    • Tang, D.I.1    Geller, N.L.2
  • 31
    • 84864011883 scopus 로고    scopus 로고
    • Adaptive extensions of a two-stage group sequential procedure for testing primary and secondary endpoints (I): unknown correlation between the endpoints
    • DOI: 10.1002/sim.5372.
    • Tamhane AC, Wu Y, Mehta C. Adaptive extensions of a two-stage group sequential procedure for testing primary and secondary endpoints (I): unknown correlation between the endpoints. Statistics in Medicine 2012; 31:2027-2040. DOI: 10.1002/sim.5372.
    • (2012) Statistics in Medicine , vol.31 , pp. 2027-2040
    • Tamhane, A.C.1    Wu, Y.2    Mehta, C.3
  • 32
    • 84864025448 scopus 로고    scopus 로고
    • Adaptive extensions of a two-stage group sequential procedure for testing primary and secondary endpoints (II): sample size re-estimation
    • DOI: 10.1002/sim.5377.
    • Tamhane AC, Wu Y, Mehta C. Adaptive extensions of a two-stage group sequential procedure for testing primary and secondary endpoints (II): sample size re-estimation. Statistics in Medicine 2012; 31:2041-2054. DOI: 10.1002/sim.5377.
    • (2012) Statistics in Medicine , vol.31 , pp. 2041-2054
    • Tamhane, A.C.1    Wu, Y.2    Mehta, C.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.