메뉴 건너뛰기




Volumn 6, Issue 3, 2007, Pages 205-216

Multiplicity and flexibility in clinical trials

Author keywords

Adaptive design; Hierarchical test; Multiple comparison; Multiple type I error rate; Step down Dunnett test; Treatment selection

Indexed keywords

ENIPORIDE; PLACEBO;

EID: 34648823145     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.302     Document Type: Review
Times cited : (49)

References (32)
  • 1
    • 33750856587 scopus 로고    scopus 로고
    • PhRMA working group on adaptive designs: Introduction to the full white paper
    • Gallo P, Krams M. PhRMA working group on adaptive designs: introduction to the full white paper. Drug Information Journal 2006; 40:421-423.
    • (2006) Drug Information Journal , vol.40 , pp. 421-423
    • Gallo, P.1    Krams, M.2
  • 2
    • 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
  • 3
    • 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
  • 4
    • 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
  • 6
    • 22044437813 scopus 로고    scopus 로고
    • An adaptive group sequential design for phase II/III clinical trials that involve treatment selection
    • Kelly PJ, Stallard N, Todd S. An adaptive group sequential design for phase II/III clinical trials that involve treatment selection. Journal of Biopharmaceutical Statistics 2005; 15:641-658.
    • (2005) Journal of Biopharmaceutical Statistics , vol.15 , pp. 641-658
    • Kelly, P.J.1    Stallard, N.2    Todd, S.3
  • 7
    • 18444411392 scopus 로고    scopus 로고
    • A new clinical trial design combining phases II and III: Sequential designs with treatment selection and a change of endpoint
    • Todd S, Stallard N. A new clinical trial design combining phases II and III: sequential designs with treatment selection and a change of endpoint. Drug Information Journal 2005; 39:109-118.
    • (2005) Drug Information Journal , vol.39 , pp. 109-118
    • Todd, S.1    Stallard, N.2
  • 8
    • 33748521268 scopus 로고    scopus 로고
    • Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: General concepts
    • Bretz F, Schmidli H, Koenig F, Racine A, Maurer W. Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: general concepts. Biometrical Journal 2006; 48:623-634.
    • (2006) Biometrical Journal , vol.48 , pp. 623-634
    • Bretz, F.1    Schmidli, H.2    Koenig, F.3    Racine, A.4    Maurer, W.5
  • 9
    • 33748533820 scopus 로고    scopus 로고
    • Confirmatory seamless phase II/ III clinical trials with hypotheses selection at interim: Applications and practical considerations
    • Schmidli H, Bretz F, Racine A, Maurer W. Confirmatory seamless phase II/ III clinical trials with hypotheses selection at interim: applications and practical considerations. Biometrical Journal 2006; 48:635-643.
    • (2006) Biometrical Journal , vol.48 , pp. 635-643
    • Schmidli, H.1    Bretz, F.2    Racine, A.3    Maurer, W.4
  • 10
    • 33748538354 scopus 로고    scopus 로고
    • An adaptive hierarchical test procedure for selecting safe and efficient treatments
    • Koenig F, Bauer P, Brannath W. An adaptive hierarchical test procedure for selecting safe and efficient treatments. Biometrical Journal 2006; 48:663-678.
    • (2006) Biometrical Journal , vol.48 , pp. 663-678
    • Koenig, F.1    Bauer, P.2    Brannath, W.3
  • 11
    • 33748528963 scopus 로고    scopus 로고
    • Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: Opportunities and limitations
    • Jennison C, Turnbull BW. Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: opportunities and limitations. Biometrical Journal 2006; 48:650-655.
    • (2006) Biometrical Journal , vol.48 , pp. 650-655
    • Jennison, C.1    Turnbull, B.W.2
  • 12
    • 34648878144 scopus 로고    scopus 로고
    • Adaptive Dunnett tests for treatment selection
    • submitted
    • Koenig F, Brannath W, Bretz F, Posch M. Adaptive Dunnett tests for treatment selection. 2006, submitted.
    • (2006)
    • Koenig, F.1    Brannath, W.2    Bretz, F.3    Posch, M.4
  • 14
    • 33748572273 scopus 로고    scopus 로고
    • Confirmatory clinical trials with an adaptive design
    • Koch A. Confirmatory clinical trials with an adaptive design. Biometrical Journal 2006; 48:574-585.
    • (2006) Biometrical Journal , vol.48 , pp. 574-585
    • Koch, A.1
  • 16
    • 34648875204 scopus 로고    scopus 로고
    • Phase II/III seamless adaptive designs with bayesian decision tools for an efficient development of a targeted therapy in oncology. Technical Report, TM 2006-05, Department of Statistics and Decision Support Systems, University of Vienna
    • Zuber E, Brannath W, Branson M, Bretz F, Gallo P, Posch M, Racine-Poon A. Phase II/III seamless adaptive designs with bayesian decision tools for an efficient development of a targeted therapy in oncology. Technical Report, TM 2006-05, Department of Statistics and Decision Support Systems, University of Vienna.
    • Zuber, E.1    Brannath, W.2    Branson, M.3    Bretz, F.4    Gallo, P.5    Posch, M.6    Racine-Poon, A.7
  • 18
    • 33750854903 scopus 로고    scopus 로고
    • Adaptive designs: Terminology and classification
    • Dragalin V. Adaptive designs: terminology and classification. Drug Information Journal 2006; 40:425-435.
    • (2006) Drug Information Journal , vol.40 , pp. 425-435
    • Dragalin, V.1
  • 19
    • 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
  • 20
    • 4344665155 scopus 로고    scopus 로고
    • A general statistical principle for changing a design any time during the course of a trial
    • Müller HH, Schäfer H. A general statistical principle for changing a design any time during the course of a trial. Statistics in Medicine 2004; 23:2497-2508.
    • (2004) Statistics in Medicine , vol.23 , pp. 2497-2508
    • Müller, H.H.1    Schäfer, H.2
  • 21
    • 34648869592 scopus 로고    scopus 로고
    • Repeated confidence intervals for adaptive group sequential trials
    • submitted
    • Mehta CR, Bauer P, Posch M, Brannath W. Repeated confidence intervals for adaptive group sequential trials. 2006, submitted.
    • (2006)
    • Mehta, C.R.1    Bauer, P.2    Posch, M.3    Brannath, W.4
  • 23
    • 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
  • 24
    • 0002020527 scopus 로고
    • Multistage testing with adaptive designs (with discussion)
    • Bauer P. Multistage testing with adaptive designs (with discussion). Biometrie und Informatik in Medizin und Biologie 1989; 20:130-148.
    • (1989) Biometrie und Informatik in Medizin und Biologie , vol.20 , pp. 130-148
    • Bauer, P.1
  • 25
    • 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
  • 26
    • 0033458198 scopus 로고    scopus 로고
    • Adaptive two stage designs and the conditional error function
    • Posch M, Bauer P. Adaptive two stage designs and the conditional error function. Biometrical Journal 1999; 41:689-696.
    • (1999) Biometrical Journal , vol.41 , pp. 689-696
    • Posch, M.1    Bauer, P.2
  • 28
    • 11844299859 scopus 로고    scopus 로고
    • Conditional rejection probabilities of Student's t-test and design adaptations
    • Posch M, Timmesfeld N, König F, Müller HH. Conditional rejection probabilities of Student's t-test and design adaptations. Biometrical Journal 2004; 46:389-403.
    • (2004) Biometrical Journal , vol.46 , pp. 389-403
    • Posch, M.1    Timmesfeld, N.2    König, F.3    Müller, H.H.4
  • 29
    • 34249038417 scopus 로고    scopus 로고
    • Increasing the sample size during clinical trials with t-distributed test statistics without inflating the type I error rate
    • Timmesfeld N, Schäfer H, Müller HH. Increasing the sample size during clinical trials with t-distributed test statistics without inflating the type I error rate. Statistics in Medicine 2006; 26:2449-2464.
    • (2006) Statistics in Medicine , vol.26 , pp. 2449-2464
    • Timmesfeld, N.1    Schäfer, H.2    Müller, H.H.3
  • 31
    • 0025805329 scopus 로고
    • Multiple testing in clinical trials
    • Bauer P. Multiple testing in clinical trials. Statistics in Medicine 1991; 10:871-889.
    • (1991) Statistics in Medicine , vol.10 , pp. 871-889
    • Bauer, P.1
  • 32
    • 1842730273 scopus 로고    scopus 로고
    • Increasing the sample size when the unblinded interim result is promising
    • Chen YHJ, DeMets DL, Lan KKG. Increasing the sample size when the unblinded interim result is promising. Statistics in Medicine 2004; 23: 1023-1038.
    • (2004) Statistics in Medicine , vol.23 , pp. 1023-1038
    • Chen, Y.H.J.1    DeMets, D.L.2    Lan, K.K.G.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.