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Volumn 26, Issue 27, 2007, Pages 5002-5013

Flexible two-stage design with sample size reassessment for survival trials

Author keywords

Flexible two stage designs; Sample size reassessment; Survival trials

Indexed keywords

CLINICAL RESEARCH; CONFERENCE PAPER; CONTROLLED STUDY; HAZARD RATIO; MATHEMATICAL COMPUTING; METHODOLOGY; SAMPLE SIZE; SIMULATION; SURVIVAL; SURVIVAL RATE; SURVIVAL TIME; SYSTEMATIC ERROR; THERAPY EFFECT;

EID: 35948935069     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.2966     Document Type: Conference Paper
Times cited : (14)

References (31)
  • 2
    • 0028619850 scopus 로고
    • Evaluation of experiments with adaptive interim analyses
    • Bauer P, Köhne K. Evaluation of experiments with adaptive interim analyses. Biometrics 1994; 50:1029-1041.
    • (1994) Biometrics , vol.50 , pp. 1029-1041
    • Bauer, P.1    Köhne, K.2
  • 3
    • 0029589385 scopus 로고
    • Designed extension of studies based on conditional power
    • Proschan MA, Hunsberger SA. Designed extension of studies based on conditional power. Biometrics 1995; 51:1315-1324.
    • (1995) Biometrics , vol.51 , pp. 1315-1324
    • Proschan, M.A.1    Hunsberger, S.A.2
  • 4
    • 0033637709 scopus 로고    scopus 로고
    • Interim analysis and sample size reassessment
    • Posch M, Bauer P. Interim analysis and sample size reassessment. Biometrics 2000; 56:1170-1176.
    • (2000) Biometrics , vol.56 , pp. 1170-1176
    • Posch, M.1    Bauer, P.2
  • 5
    • 0035977433 scopus 로고    scopus 로고
    • Modification of the sample size and the schedule of interim analyses in survival trials based on data inspections
    • Schäfer H, Müller HH. Modification of the sample size and the schedule of interim analyses in survival trials based on data inspections. Statistics in Medicine 2001; 20:3741-3751.
    • (2001) Statistics in Medicine , vol.20 , pp. 3741-3751
    • Schäfer, H.1    Müller, H.H.2
  • 7
    • 0037473229 scopus 로고    scopus 로고
    • Mid-course sample size modification in clinical trials based on the observed treatment effect
    • Jennison C, Turnbull B. 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.2
  • 8
    • 22044432415 scopus 로고    scopus 로고
    • Two-stage adaptive design for clinical trials with survival data
    • Li G, Shih W, Wang Y. Two-stage adaptive design for clinical trials with survival data. Journal of Biopharmaceutical Statistics 2005; 15:707-718.
    • (2005) Journal of Biopharmaceutical Statistics , vol.15 , pp. 707-718
    • Li, G.1    Shih, W.2    Wang, Y.3
  • 9
    • 0036399486 scopus 로고    scopus 로고
    • Strategies for changing the test statistics during a clinical trials
    • Lawrence J. Strategies for changing the test statistics during a clinical trials. Journal of Biopharmaceutical Statistics 2002; 12:193-205.
    • (2002) Journal of Biopharmaceutical Statistics , vol.12 , pp. 193-205
    • Lawrence, J.1
  • 10
    • 0036337649 scopus 로고    scopus 로고
    • A bootstrap procedure for adaptive selection of the test statistic in flexible two-stage designs
    • Kieser M, Schneider B, Friede T. A bootstrap procedure for adaptive selection of the test statistic in flexible two-stage designs. Biometrical Journal 2002; 44:641-652.
    • (2002) Biometrical Journal , vol.44 , pp. 641-652
    • Kieser, M.1    Schneider, B.2    Friede, T.3
  • 11
    • 0033434895 scopus 로고    scopus 로고
    • Inference on multiple endpoints in clinical trials with adaptive interim analyses
    • Kieser M, Bauer P, Lehmacher W. Inference on multiple endpoints in clinical trials with adaptive interim analyses. Biometrical Journal 1999; 41:261-277.
    • (1999) Biometrical Journal , vol.41 , pp. 261-277
    • Kieser, M.1    Bauer, P.2    Lehmacher, W.3
  • 12
    • 0040374501 scopus 로고    scopus 로고
    • Adaptive modifications of hypotheses after an interim analysis
    • Hommel G. Adaptive modifications of hypotheses after an interim analysis. Biometrical Journal 2001; 43:581-589.
    • (2001) Biometrical Journal , vol.43 , pp. 581-589
    • Hommel, G.1
  • 13
    • 0029098554 scopus 로고
    • An adaptive method for establishing a dose-response relationship
    • Bauer P, Röhmel J. An adaptive method for establishing a dose-response relationship. Statistics in Medicine 1995; 14:1595-1607.
    • (1995) Statistics in Medicine , vol.14 , pp. 1595-1607
    • Bauer, P.1    Röhmel, J.2
  • 14
    • 0032582081 scopus 로고    scopus 로고
    • Testing strategies in multi-dose experiments including active control
    • Bauer P, Röhmel J, Maurer W, Hothorn L. Testing strategies in multi-dose experiments including active control. Statistics in Medicine 1998; 17:2133-2146.
    • (1998) Statistics in Medicine , vol.17 , pp. 2133-2146
    • Bauer, P.1    Röhmel, J.2    Maurer, W.3    Hothorn, L.4
  • 15
    • 0033618626 scopus 로고    scopus 로고
    • Combining different phases in the development of medical treatments within a single trial
    • Bauer P, Kieser M. Combining different phases in the development of medical treatments within a single trial. Statistics in Medicine 1999; 18:1833-1848.
    • (1999) Statistics in Medicine , vol.18 , pp. 1833-1848
    • Bauer, P.1    Kieser, M.2
  • 17
    • 0021745696 scopus 로고
    • Why do we need some large, simple randomized trials?
    • Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials? Statistics in Medicine 1984; 3:409-422.
    • (1984) Statistics in Medicine , vol.3 , pp. 409-422
    • Yusuf, S.1    Collins, R.2    Peto, R.3
  • 18
    • 0012398106 scopus 로고    scopus 로고
    • A sample size adjustment procedure for clinical trials based on conditional power
    • Li C, Shih W, Xie T, Lu J. A sample size adjustment procedure for clinical trials based on conditional power. Biostatistics 2002; 3:277-287.
    • (2002) Biostatistics , vol.3 , pp. 277-287
    • Li, C.1    Shih, W.2    Xie, T.3    Lu, J.4
  • 20
    • 0000491069 scopus 로고
    • The asymptotic joint distribution of the efficient scores test for the proportional hazards model calculated over time
    • Tsiatis AA. The asymptotic joint distribution of the efficient scores test for the proportional hazards model calculated over time. Biometrika 1981; 68:311-315.
    • (1981) Biometrika , vol.68 , pp. 311-315
    • Tsiatis, A.A.1
  • 21
    • 84916364348 scopus 로고
    • Repeated significance testing for a general class of statistics used in censored survival analysis
    • Tsiatis AA. Repeated significance testing for a general class of statistics used in censored survival analysis. Journal of the American Statistical Association 1982; 77:855-861.
    • (1982) Journal of the American Statistical Association , vol.77 , pp. 855-861
    • Tsiatis, A.A.1
  • 22
    • 0000020146 scopus 로고
    • Sequential analysis of the proportional hazards model
    • Sellke T, Siegmund D. Sequential analysis of the proportional hazards model. Biometrika 1982; 70:315-326.
    • (1982) Biometrika , vol.70 , pp. 315-326
    • Sellke, T.1    Siegmund, D.2
  • 23
    • 0020399170 scopus 로고
    • Tables of the number of patients required in clinical trials using the logrank test
    • Freedman LS. Tables of the number of patients required in clinical trials using the logrank test. Statistics in Medicine 1982; 1:121-129.
    • (1982) Statistics in Medicine , vol.1 , pp. 121-129
    • Freedman, L.S.1
  • 24
    • 0020974571 scopus 로고
    • Sample-size formula for the proportional-hazards regression model
    • Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics 1983; 39: 499-503.
    • (1983) Biometrics , vol.39 , pp. 499-503
    • Schoenfeld, D.A.1
  • 26
    • 0035884250 scopus 로고    scopus 로고
    • Sample size recalculation using conditional power
    • Denne J. Sample size recalculation using conditional power. Statistics in Medicine 2001; 20:2645-2660.
    • (2001) Statistics in Medicine , vol.20 , pp. 2645-2660
    • Denne, J.1
  • 27
    • 1842826262 scopus 로고    scopus 로고
    • On the efficiency of the adaptive design for monitoring clinical trials
    • Tsiatis A, Metha C. On the efficiency of the adaptive design for monitoring clinical trials. Biometrika 2003; 90:367-378.
    • (2003) Biometrika , vol.90 , pp. 367-378
    • Tsiatis, A.1    Metha, C.2
  • 28
    • 0035977433 scopus 로고    scopus 로고
    • Bauer P, Posch M. Modification of the sample size and the schedule of interim analyses in survival trials based on data inspections, by H. Schäffer and H.-H. Müller. Statistics in Medicine 2001; 20:3741-3751; Statistics in Medicine 2004; 23:1333-1334; Authors Reply 1334-1335.
    • Bauer P, Posch M. Modification of the sample size and the schedule of interim analyses in survival trials based on data inspections, by H. Schäffer and H.-H. Müller. Statistics in Medicine 2001; 20:3741-3751; Statistics in Medicine 2004; 23:1333-1334; Authors Reply 1334-1335.
  • 29
    • 0022771685 scopus 로고
    • Evaluation of sample size and power for analyses of survival with allowance for nonuniform patient entry, losses to follow-up, noncompliance, and stratification
    • Lachin JM, Foulkes MA. Evaluation of sample size and power for analyses of survival with allowance for nonuniform patient entry, losses to follow-up, noncompliance, and stratification. Biometrics 1986; 42:507-519.
    • (1986) Biometrics , vol.42 , pp. 507-519
    • Lachin, J.M.1    Foulkes, M.A.2
  • 30
    • 0036911409 scopus 로고    scopus 로고
    • Sample size correction for treatment crossovers in randomized clinical trials with a survival endpoint
    • Porcher R, Lévy V, Chevret S. Sample size correction for treatment crossovers in randomized clinical trials with a survival endpoint. Controlled Clinical Trials 2002; 23:650-661.
    • (2002) Controlled Clinical Trials , vol.23 , pp. 650-661
    • Porcher, R.1    Lévy, V.2    Chevret, S.3
  • 31
    • 0032518741 scopus 로고    scopus 로고
    • Modifying the design of ongoing trials without unblinding
    • Gould A, Shih W. Modifying the design of ongoing trials without unblinding. Statistics in Medicine 1998; 17:89-100.
    • (1998) Statistics in Medicine , vol.17 , pp. 89-100
    • Gould, A.1    Shih, W.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.