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Volumn 48, Issue 4, 2006, Pages 507-520

An overview of statistical approaches for adaptive designs and design modifications

Author keywords

Adaptive designs; Combination tests; Conditional error function; Conditional error probability; Design modifications

Indexed keywords

CURRICULA; MEDICAL APPLICATIONS; SAMPLING;

EID: 33748560148     PISSN: 03233847     EISSN: 15214036     Source Type: Journal    
DOI: 10.1002/bimj.200510234     Document Type: Review
Times cited : (23)

References (53)
  • 3
    • 1842736272 scopus 로고    scopus 로고
    • The advantages and disadvantages of adaptive designs for clinical trials
    • Bauer, P. and Brannath, W. (2004). The advantages and disadvantages of adaptive designs for clinical trials. Drug Discovery Today 9, 35 1-357.
    • (2004) Drug Discovery Today , vol.9 , pp. 351-357
    • Bauer, P.1    Brannath, W.2
  • 4
    • 0033618626 scopus 로고    scopus 로고
    • Combining different phases in the development of medical treatments within a single trial
    • Bauer, P. and Kieser, M. (1999). Combining different phases in the development of medical treatments within a single trial. Statistics in Medicine 18, 1833-1848.
    • (1999) Statistics in Medicine , vol.18 , pp. 1833-1848
    • Bauer, P.1    Kieser, M.2
  • 5
    • 0028619850 scopus 로고
    • Evaluation of experiments with adaptive interim analyses
    • Bauer, P. and Köhne, K. (1994). Evaluation of experiments with adaptive interim analyses. Biometrics 50, 1029-1041.
    • (1994) Biometrics , vol.50 , pp. 1029-1041
    • Bauer, P.1    Köhne, K.2
  • 6
    • 4444274981 scopus 로고    scopus 로고
    • Optimal conditional error functions for the control of conditional power
    • Brannath, W., and Bauer, P. (2004). Optimal conditional error functions for the control of conditional power. Biometrics 60, 715-723.
    • (2004) Biometrics , vol.60 , pp. 715-723
    • Brannath, W.1    Bauer, P.2
  • 7
    • 85163905483 scopus 로고    scopus 로고
    • Estimation in flexible two-stage designs
    • Epub ahead of print Oct. 11
    • Brannath, W., König, F. and Bauer, P. (2005). Estimation in flexible two-stage designs. Statistics in Medicine Epub ahead of print Oct. 11.
    • (2005) Statistics in Medicine
    • Brannath, W.1    König, F.2    Bauer, P.3
  • 9
    • 0032886394 scopus 로고    scopus 로고
    • Modification of sample size in group sequential clinical trials
    • Cui, L., Hung, H. M. J., and Wang, S. J. (1999). Modification of sample size in group sequential clinical trials. Biometrics 55, 853-857.
    • (1999) Biometrics , vol.55 , pp. 853-857
    • Cui, L.1    Hung, H.M.J.2    Wang, S.J.3
  • 10
    • 0027934302 scopus 로고
    • Interim analysis - The alpha-spending function-approach
    • DeMets, D. L. and Lan, K. K. G. (1994). Interim analysis - the alpha-spending function-approach. Statistics in Medicine 13, 1341-1352.
    • (1994) Statistics in Medicine , vol.13 , pp. 1341-1352
    • DeMets, D.L.1    Lan, K.K.G.2
  • 11
    • 0035884250 scopus 로고    scopus 로고
    • Sample size recalculation using conditional power
    • Denne, J. S. (2001). Sample size recalculation using conditional power, Statistics in Medicine 20, 2645-2660.
    • (2001) Statistics in Medicine , vol.20 , pp. 2645-2660
    • Denne, J.S.1
  • 12
    • 0003101751 scopus 로고    scopus 로고
    • A group sequential t-test with updating of sample size
    • Denne, J. S. and Jennison, C. (2000). A group sequential t-test with updating of sample size. Biometrika 87, 125-134.
    • (2000) Biometrika , vol.87 , pp. 125-134
    • Denne, J.S.1    Jennison, C.2
  • 13
    • 0032581580 scopus 로고    scopus 로고
    • Self-designing clinical trials
    • Fisher, L. D. (1998). Self-designing clinical trials. Statistics in Medicine 17, 1551-1562.
    • (1998) Statistics in Medicine , vol.17 , pp. 1551-1562
    • Fisher, L.D.1
  • 14
    • 33748550685 scopus 로고    scopus 로고
    • Sample size recalculation in internal pilot study designs: A review
    • Friede, T and Kieser, M. (2006). Sample size recalculation in internal pilot study designs: A Review. Biometrical Journal 48, 537-555.
    • (2006) Biometrical Journal , vol.48 , pp. 537-555
    • Friede, T.1    Kieser, M.2
  • 15
    • 0035074070 scopus 로고    scopus 로고
    • A self-designing rule for clinical trials with arbitrary response variables
    • Hartung, J. (2001). A self-designing rule for clinical trials with arbitrary response variables. Controlled Clinical Trials 22, 111-116.
    • (2001) Controlled Clinical Trials , vol.22 , pp. 111-116
    • Hartung, J.1
  • 16
    • 33748543613 scopus 로고    scopus 로고
    • Flexible designs by adaptive plans of generalized Pocock- and O'Brien-Fleming-type and by self-designing clinical trials
    • Hartung, J. (2006). Flexible designs by adaptive plans of generalized Pocock- and O'Brien-Fleming-type and by self-designing clinical trials. Biometrical Journal 48, 521-536.
    • (2006) Biometrical Journal , vol.48 , pp. 521-536
    • Hartung, J.1
  • 17
    • 0037283425 scopus 로고    scopus 로고
    • A new class of completely self-designing clinical trials
    • Hartung, J. and Knapp, G. (2003). A new class of completely self-designing clinical trials. Biometrical Journal 45, 3-19.
    • (2003) Biometrical Journal , vol.45 , pp. 3-19
    • Hartung, J.1    Knapp, G.2
  • 19
    • 33748519263 scopus 로고    scopus 로고
    • A regulatory view on adaptive/flexible clinical trial design
    • Hung, H. M. J., O'Neill, R. T., Wang, S. J. and Lawrence, J. (2006). A regulatory view on adaptive/flexible clinical trial design. Biometrical Journal 48, 565-573.
    • (2006) Biometrical Journal , vol.48 , pp. 565-573
    • Hung, H.M.J.1    O'Neill, R.T.2    Wang, S.J.3    Lawrence, J.4
  • 21
    • 0033434895 scopus 로고    scopus 로고
    • Inference on multiple endpoints in clinical trials with adaptive interim analyses
    • Kieser, M., Bauer, P., and Lehmacher, W. (1999). Inference on multiple endpoints in clinical trials with adaptive interim analyses. Biometrical Journal 41, 261-277.
    • (1999) Biometrical Journal , vol.41 , pp. 261-277
    • Kieser, M.1    Bauer, P.2    Lehmacher, W.3
  • 22
    • 0034656288 scopus 로고    scopus 로고
    • Re-calculating the sample size in internal pilot study designs with control of the type I error rate
    • Kieser, M. and Friede, T. (2000). Re-calculating the sample size in internal pilot study designs with control of the type I error rate. Statistics in Medicine 19, 901-911.
    • (2000) Statistics in Medicine , vol.19 , pp. 901-911
    • Kieser, M.1    Friede, T.2
  • 23
    • 0000785248 scopus 로고
    • Design and analysis of group sequential tests based on the type I error spending rate function
    • Kim, K. and DeMets, D. L. (1987). Design and analysis of group sequential tests based on the type I error spending rate function. Biometrika 74, 149-154.
    • (1987) Biometrika , vol.74 , pp. 149-154
    • Kim, K.1    DeMets, D.L.2
  • 24
    • 33748572273 scopus 로고    scopus 로고
    • Confirmatory clinical trials with an adaptive design
    • Koch, A. (2006). Confirmatory clinical trials with an adaptive design. Biometrical Journal 48, 574-585.
    • (2006) Biometrical Journal , vol.48 , pp. 574-585
    • Koch, A.1
  • 25
    • 70449529019 scopus 로고
    • Discrete sequential boundaries for clinical trials
    • Lan, K. K. G. and DeMets, D. L. (1983). Discrete sequential boundaries for clinical trials. Biometrika 70, 659-663.
    • (1983) Biometrika , vol.70 , pp. 659-663
    • Lan, K.K.G.1    DeMets, D.L.2
  • 26
    • 0024444164 scopus 로고
    • Changing frequency of interim analysis in sequential monitoring
    • Lan, K. K. G. and DeMets, D. L. (1989). Changing frequency of interim analysis in sequential monitoring. Biometrics 45, 1017-1020.
    • (1989) Biometrics , vol.45 , pp. 1017-1020
    • Lan, K.K.G.1    DeMets, D.L.2
  • 27
    • 0032732411 scopus 로고    scopus 로고
    • Adaptive sample size calculations in group sequential trials
    • Lehmacher, W. and Wassmer, G. (1999). Adaptive sample size calculations in group sequential trials. Biometrics 55, 1286-1290.
    • (1999) Biometrics , vol.55 , pp. 1286-1290
    • Lehmacher, W.1    Wassmer, G.2
  • 28
    • 0034876356 scopus 로고    scopus 로고
    • Adaptive group sequential designs for clinical trials: Combining the advantages of adaptive and of classical group sequential approaches
    • Müller, H. H. and Schäfer, H. (2001). Adaptive group sequential designs for clinical trials: Combining the advantages of adaptive and of classical group sequential approaches. Biometrics 57, 886-891.
    • (2001) Biometrics , vol.57 , pp. 886-891
    • Müller, H.H.1    Schäfer, H.2
  • 29
    • 4344665155 scopus 로고    scopus 로고
    • A general statistical principle for changing a design any time during the course ofa trial
    • Müller, H. H. and Schäfer, H. (2004). A general statistical principle for changing a design any time during the course ofa trial. Statistics in Medicine 23, 2497-2508.
    • (2004) Statistics in Medicine , vol.23 , pp. 2497-2508
    • Müller, H.H.1    Schäfer, H.2
  • 30
    • 0018687930 scopus 로고
    • A multiple testing procedure for clinical trials
    • O'Brien, P. C. and Fleming, T. R. (1979). A multiple testing procedure for clinical trials. Biometrika 35, 549-556.
    • (1979) Biometrika , vol.35 , pp. 549-556
    • O'Brien, P.C.1    Fleming, T.R.2
  • 31
    • 33748534646 scopus 로고    scopus 로고
    • Groupseq - Designing clinical trials using group sequential designs
    • Pahl, R., Ziegler, A., and König, I. K. (2006). Groupseq - designing clinical trials using group sequential designs. Rnews 6, 21-26.
    • (2006) Rnews , vol.6 , pp. 21-26
    • Pahl, R.1    Ziegler, A.2    König, I.K.3
  • 32
    • 0017744944 scopus 로고
    • Group sequential methods in the design and analyis of clinical trials
    • Pocock, S. J. (1977). Group sequential methods in the design and analyis of clinical trials. Biometrika 64, 191-199.
    • (1977) Biometrika , vol.64 , pp. 191-199
    • Pocock, S.J.1
  • 33
    • 0020110252 scopus 로고
    • Interim analyses for randomized clinical trials: The group sequential approach
    • Pocock, S. J. (1982). Interim analyses for randomized clinical trials: The group sequential approach. Biometrics 38, 153-162.
    • (1982) Biometrics , vol.38 , pp. 153-162
    • Pocock, S.J.1
  • 34
    • 0038374823 scopus 로고    scopus 로고
    • The geometry of two-stage tests
    • Proschan, M. A. (2003). The geometry of two-stage tests. Statistica Sinica 13, 163-177.
    • (2003) Statistica Sinica , vol.13 , pp. 163-177
    • Proschan, M.A.1
  • 35
    • 22044443101 scopus 로고    scopus 로고
    • Two-stage sample size re-estimation based on a nuisance parameter: A review
    • Proschan, M. A. (2005). Two-stage sample size re-estimation based on a nuisance parameter: a review. Journal of Biopharmaceutical Statistics 15, 559-574.
    • (2005) Journal of Biopharmaceutical Statistics , vol.15 , pp. 559-574
    • Proschan, M.A.1
  • 36
    • 0027082308 scopus 로고
    • Effects of assumption violations on type I error rate in group sequential monitoring
    • Proschan, M. A., Follmann, D. A., and Waclawiw, M. A. (1992). Effects of assumption violations on type I error rate in group sequential monitoring. Biometrics 48, 1131-1143.
    • (1992) Biometrics , vol.48 , pp. 1131-1143
    • Proschan, M.A.1    Follmann, D.A.2    Waclawiw, M.A.3
  • 37
    • 0029589385 scopus 로고
    • Designed extension of studies based on conditional power
    • Proschan, M. A. and Hunsberger, S. A. (1995). Designed extension of studies based on conditional power. Biometrics 51, 13 15-1324.
    • (1995) Biometrics , vol.51 , pp. 1315-1324
    • Proschan, M.A.1    Hunsberger, S.A.2
  • 38
    • 0042859846 scopus 로고    scopus 로고
    • Optimal two-stage genotyping in population-based association studies
    • Satagopan, J. M. and Elston, R. C. (2003). Optimal two-stage genotyping in population-based association studies. Genetic Epidemiology 25, 149-157.
    • (2003) Genetic Epidemiology , vol.25 , pp. 149-157
    • Satagopan, J.M.1    Elston, R.C.2
  • 39
    • 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. and Müller, H. H. (2001). Modification of the sample size and the schedule of interim analyses in survival trials based on data inspections. Statistics in Medicine 20, 3741-3751.
    • (2001) Statistics in Medicine , vol.20 , pp. 3741-3751
    • Schäfer, H.1    Müller, H.H.2
  • 40
    • 0344395010 scopus 로고    scopus 로고
    • Data adaptive interim modification of sample sizes for candidate-gene association studies
    • Scherag, A., Müller, H. H., Dempfle, A., Hebebrand, J., and Schäfer, H. (2003). Data adaptive interim modification of sample sizes for candidate-gene association studies. Human Heredity 56, 56-62.
    • (2003) Human Heredity , vol.56 , pp. 56-62
    • Scherag, A.1    Müller, H.H.2    Dempfle, A.3    Hebebrand, J.4    Schäfer, H.5
  • 41
    • 85163905952 scopus 로고
    • Optimal Sequentially Planned Decision Procedures, Springer, New York
    • Schmitz, N. (1993). Optimal Sequentially Planned Decision Procedures, Springer, New York, vol. 79 of Lecture Notes in Statistics.
    • (1993) Lecture Notes in Statistics , vol.79
    • Schmitz, N.1
  • 42
    • 0032904107 scopus 로고    scopus 로고
    • Statistical inference for self-designing clinical trials with a one-sided hypothesis
    • Shen, Y. and Fisher, L. (1999). Statistical inference for self-designing clinical trials with a one-sided hypothesis. Biometrics 55, 190-197.
    • (1999) Biometrics , vol.55 , pp. 190-197
    • Shen, Y.1    Fisher, L.2
  • 43
    • 10044277900 scopus 로고    scopus 로고
    • Two-stage sampling designs for gene association studies
    • Thomas, D., Xie, R. R., and Gebregziabher, M. (2004). Two-stage sampling designs for gene association studies. Genetic Epidemiology 27, 401-414.
    • (2004) Genetic Epidemiology , vol.27 , pp. 401-414
    • Thomas, D.1    Xie, R.R.2    Gebregziabher, M.3
  • 44
    • 23944469845 scopus 로고    scopus 로고
    • Recent developments in genomewide association scans: A workshop summary and review
    • Thomas, D. C., Haile, R. W., and Duggan, D. (2005). Recent developments in genomewide association scans: A workshop summary and review. American Journal of Human Genetics 77, 337-345.
    • (2005) American Journal of Human Genetics , vol.77 , pp. 337-345
    • Thomas, D.C.1    Haile, R.W.2    Duggan, D.3
  • 46
    • 1842826262 scopus 로고    scopus 로고
    • On the inefficiency of the adaptive design for monitoring clinical trials
    • Tsiatis, A. A. and Mehta, C. (2003). On the inefficiency of the adaptive design for monitoring clinical trials. Biometrika 90, 367-378.
    • (2003) Biometrika , vol.90 , pp. 367-378
    • Tsiatis, A.A.1    Mehta, C.2
  • 47
    • 0021499106 scopus 로고
    • Exact confidence intervals following a group sequential test
    • Tsiatis, A. A., Rosner, G. L., and Mehta, C. R. (1984). Exact confidence intervals following a group sequential test. Biometrics 40, 797-803.
    • (1984) Biometrics , vol.40 , pp. 797-803
    • Tsiatis, A.A.1    Rosner, G.L.2    Mehta, C.R.3
  • 48
    • 0031799618 scopus 로고    scopus 로고
    • A comparison of two methods for adaptive interim analyses in clinical trials
    • Wassmer, G. (1998). A comparison of two methods for adaptive interim analyses in clinical trials. Biometrics 54, 696-705.
    • (1998) Biometrics , vol.54 , pp. 696-705
    • Wassmer, G.1
  • 49
    • 0033469293 scopus 로고    scopus 로고
    • Multistage adaptive test procedures based on Fisher's product criterion
    • Wassmer, G. (1999). Multistage adaptive test procedures based on Fisher's product criterion. Biometrical Journal 41, 279-293.
    • (1999) Biometrical Journal , vol.41 , pp. 279-293
    • Wassmer, G.1
  • 50
    • 33748560822 scopus 로고    scopus 로고
    • A brief review on software developments for group sequential and adaptive designs
    • Wassmer, G. and Vandemeulebroecke, M. (2006). A brief review on software developments for group sequential and adaptive designs. Biometrical Journal 48, 732-737.
    • (2006) Biometrical Journal , vol.48 , pp. 732-737
    • Wassmer, G.1    Vandemeulebroecke, M.2
  • 52
    • 0020729398 scopus 로고
    • Group sequential clinical trials with triangular continuation regions
    • Whitehead, J. and Stratton, I. (1983). Group sequential clinical trials with triangular continuation regions. Biometrics 39, 227-236.
    • (1983) Biometrics , vol.39 , pp. 227-236
    • Whitehead, J.1    Stratton, I.2
  • 53
    • 27544506863 scopus 로고    scopus 로고
    • Two-stage designs for experiments with a large number of hypotheses
    • Zehetmayer, S., Bauer, P., and Posch, M. (2005). Two-stage designs for experiments with a large number of hypotheses. Bioinformatics 21, 3771-3777.
    • (2005) Bioinformatics , vol.21 , pp. 3771-3777
    • Zehetmayer, S.1    Bauer, P.2    Posch, M.3


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