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Volumn 40, Issue 3, 2006, Pages 345-353

The WIZARD trial as a case study of flexible clinical trial design

Author keywords

Adaptive design; Composite end points; Conditional power; Event driven trials; Group sequential testing

Indexed keywords

AZITHROMYCIN;

EID: 33747608207     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150604000313     Document Type: Review
Times cited : (8)

References (24)
  • 1
    • 0034049838 scopus 로고    scopus 로고
    • Rationale and design of a secondary prevention trial of antibiotic use in patients after myocardial infarction: The WIZARD ([Weekly Intervention with Zithromax Azithromycin] for Atherosclerosis and Its Related Disorders) trial
    • Dunne MW. Rationale and design of a secondary prevention trial of antibiotic use in patients after myocardial infarction: the WIZARD ([Weekly Intervention with Zithromax Azithromycin] for Atherosclerosis and Its Related Disorders) trial. J Infect Dis. 2000;181(suppl 3):S572-S578.
    • (2000) J Infect Dis , vol.181 , Issue.SUPPL. 3
    • Dunne, M.W.1
  • 2
    • 0141723577 scopus 로고    scopus 로고
    • A double-blind, randomized, placebo controlled trial of azithromycin for the secondary prevention of coronary heart disease: The WIZARD trial
    • O'Connor CM, Dunne MW, Pfeffer MA, et al. A double-blind, randomized, placebo controlled trial of azithromycin for the secondary prevention of coronary heart disease: the WIZARD trial. JAMA. 2003;290:1459-1466.
    • (2003) JAMA , vol.290 , pp. 1459-1466
    • O'Connor, C.M.1    Dunne, M.W.2    Pfeffer, M.A.3
  • 4
    • 0018687930 scopus 로고
    • A multiple testing procedure for clinical trials
    • O'Brien P, Fleming T. A multiple testing procedure for clinical trials. Biometrics. 1979;35:549-556.
    • (1979) Biometrics , vol.35 , pp. 549-556
    • O'Brien, P.1    Fleming, T.2
  • 5
    • 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
  • 6
    • 0023677293 scopus 로고
    • The B-value: A tool for monitoring data
    • Lan KKG, Wittes J. The B-value: a tool for monitoring data. Biometrics. 1988;44:579-585.
    • (1988) Biometrics , vol.44 , pp. 579-585
    • Lan, K.K.G.1    Wittes, J.2
  • 7
    • 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
  • 8
    • 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
  • 9
    • 0032732411 scopus 로고    scopus 로고
    • Adaptive sample size calculations in group sequential trials
    • Lehmacher W, Wassmer G. Adaptive sample size calculations in group sequential trials. Biometrics. 1999;55:1286-1290.
    • (1999) Biometrics , vol.55 , pp. 1286-1290
    • Lehmacher, W.1    Wassmer, G.2
  • 10
    • 0034876356 scopus 로고    scopus 로고
    • Adaptive group sequential designs for clinical trials: Combining the advantages of adaptive and of classical group sequential approaches
    • Müller HH, Schäfer H. Adaptive group sequential designs for clinical trials: combining the advantages of adaptive and of classical group sequential approaches. Biometrics. 2001;57:886-891.
    • (2001) Biometrics , vol.57 , pp. 886-891
    • Müller, H.H.1    Schäfer, H.2
  • 11
    • 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
  • 12
    • 0002857793 scopus 로고    scopus 로고
    • Estimation of parameters and sample size re-estimation
    • Alexandria, VA: American Statistical Association
    • Lan KKG, Trost DC. Estimation of parameters and sample size re-estimation. In: ASA Proceedings of the Biopharmaceutical Section. Alexandria, VA: American Statistical Association; 1997:48-51.
    • (1997) ASA Proceedings of the Biopharmaceutical Section , pp. 48-51
    • Lan, K.K.G.1    Trost, D.C.2
  • 13
    • 0032581580 scopus 로고    scopus 로고
    • Self-designing clinical trials
    • Fisher LD. Self-designing clinical trials. Stat Med. 1998;17:1551-1562.
    • (1998) Stat Med , vol.17 , pp. 1551-1562
    • Fisher, L.D.1
  • 14
    • 0032904107 scopus 로고    scopus 로고
    • Statistical inference for self-designing clinical trials with a one-sided hypothesis
    • Shen Y, Fisher L. Statistical inference for self-designing clinical trials with a one-sided hypothesis. Biometrics. 1999;55:190-197.
    • (1999) Biometrics , vol.55 , pp. 190-197
    • Shen, Y.1    Fisher, L.2
  • 15
    • 0032886394 scopus 로고    scopus 로고
    • Modification of sample size in group sequential clinical trials
    • Cui L, Hung HMJ, Wang SJ. Modification of sample size in group sequential clinical trials. Biometrics. 1999;55:853-857.
    • (1999) Biometrics , vol.55 , pp. 853-857
    • Cui, L.1    Hung, H.M.J.2    Wang, S.J.3
  • 16
    • 0012398106 scopus 로고    scopus 로고
    • A sample size adjustment procedure for clinical trials based on conditional power
    • Li G, Shih WJ, 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, G.1    Shih, W.J.2    Xie, T.3    Lu, J.4
  • 17
    • 0024994537 scopus 로고
    • The role of internal pilot studies in increasing the efficiency of clinical trials
    • Wittes J, Brittain E. The role of internal pilot studies in increasing the efficiency of clinical trials (with comments). Stat Med. 1990;9:65-72.
    • (1990) Stat Med , vol.9 , pp. 65-72
    • Wittes, J.1    Brittain, E.2
  • 18
    • 0032518741 scopus 로고    scopus 로고
    • Modifying the design of ongoing trials without unblinding
    • Gould AL, Shih WJ. Modifying the design of ongoing trials without unblinding. Stat Med. 1998;17:89-100.
    • (1998) Stat Med , vol.17 , pp. 89-100
    • Gould, A.L.1    Shih, W.J.2
  • 19
    • 10444240896 scopus 로고    scopus 로고
    • Sample size recalculation for binary data in internal pilot study designs
    • Friede T, Kieser M. Sample size recalculation for binary data in internal pilot study designs. Pharm Stat. 2004;3:269-279.
    • (2004) Pharm Stat , vol.3 , pp. 269-279
    • Friede, T.1    Kieser, M.2
  • 20
    • 0242691988 scopus 로고    scopus 로고
    • Methods for mid-course corrections in clinical trials with survival outcomes
    • Cook TD. Methods for mid-course corrections in clinical trials with survival outcomes. Stat Med. 2003;22:3431-3447.
    • (2003) Stat Med , vol.22 , pp. 3431-3447
    • Cook, T.D.1
  • 21
    • 0022977286 scopus 로고
    • Sample size determination in clinical trials with time-dependent rates of losses and noncompliance
    • Lakatos E. Sample size determination in clinical trials with time-dependent rates of losses and noncompliance. Controlled Clin Trials. 1986;7: 189-199.
    • (1986) Controlled Clin Trials , vol.7 , pp. 189-199
    • Lakatos, E.1
  • 22
    • 0023896164 scopus 로고
    • Sample sizes based on the log-rank statistic in complex clinical trials
    • Lakatos E. Sample sizes based on the log-rank statistic in complex clinical trials. Biometrics. 1988;44:229-241.
    • (1988) Biometrics , vol.44 , pp. 229-241
    • Lakatos, E.1
  • 23
    • 0000092346 scopus 로고
    • Repeated significance tests on accumulating data
    • Armitage P, McPherson C, Rowe B. Repeated significance tests on accumulating data. J R Stat Soc Ser A. 1969;132:235-244.
    • (1969) J R Stat Soc Ser A , vol.132 , pp. 235-244
    • Armitage, P.1    McPherson, C.2    Rowe, B.3
  • 24
    • 0034102702 scopus 로고    scopus 로고
    • Computations for group sequential boundaries using the Lan-DeMets spending function method
    • Reboussin DM, DeMets DL, Kim K, Lan KKG. Computations for group sequential boundaries using the Lan-DeMets spending function method. Controlled Clin Trials. 2000;21:190-207.
    • (2000) Controlled Clin Trials , vol.21 , pp. 190-207
    • Reboussin, D.M.1    DeMets, D.L.2    Kim, K.3    Lan, K.K.G.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.