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Volumn 33, Issue 5, 2012, Pages 1088-1093

Sample size re-estimation in an on-going NIH-sponsored clinical trial: The secondary prevention of small subcortical strokes experience

Author keywords

Randomized clinical trial; Sample size re estimation; SPS3

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL;

EID: 84864295698     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2012.06.007     Document Type: Article
Times cited : (7)

References (41)
  • 1
    • 33750854903 scopus 로고    scopus 로고
    • Adaptive designs: terminology and classification
    • Dragalin V. Adaptive designs: terminology and classification. Drug Inf J 2006, 40:425-435.
    • (2006) Drug Inf J , vol.40 , pp. 425-435
    • Dragalin, V.1
  • 3
    • 44949171503 scopus 로고    scopus 로고
    • Adaptive design methods in clinical trials - a review
    • Chow S.C., Chang M. Adaptive design methods in clinical trials - a review. Orphanet J Rare Dis 2008, 3:11.
    • (2008) Orphanet J Rare Dis , vol.3 , pp. 11
    • Chow, S.C.1    Chang, M.2
  • 4
    • 46349091495 scopus 로고    scopus 로고
    • Adaptive clinical trials: progress and challenges
    • Coffey C.S., Kairalla J.A. Adaptive clinical trials: progress and challenges. Drugs R&D 2008, 9:229-242.
    • (2008) Drugs R&D , vol.9 , pp. 229-242
    • Coffey, C.S.1    Kairalla, J.A.2
  • 6
    • 65649093620 scopus 로고    scopus 로고
    • Adaptive designs for confirmatory clinical trials
    • Bretz F., Koenig F., Brannath W., Glimm E., Posch M. Adaptive designs for confirmatory clinical trials. Stat Med 2009, 28:1181-1217.
    • (2009) Stat Med , vol.28 , pp. 1181-1217
    • Bretz, F.1    Koenig, F.2    Brannath, W.3    Glimm, E.4    Posch, M.5
  • 7
    • 70350139975 scopus 로고    scopus 로고
    • Good practices for adaptive clinical trials in pharmaceutical product development
    • Gaydos B., Anderson K.B., Berry D., et al. Good practices for adaptive clinical trials in pharmaceutical product development. Drug Inf J 2009, 43:539-556.
    • (2009) Drug Inf J , vol.43 , pp. 539-556
    • Gaydos, B.1    Anderson, K.B.2    Berry, D.3
  • 8
    • 77953666447 scopus 로고    scopus 로고
    • Barriers and opportunities for implementation of adaptive designs in pharmaceutical product development
    • Quinlan J., Gaydos B., Maca J., Krams M. Barriers and opportunities for implementation of adaptive designs in pharmaceutical product development. Clin Trials 2010, 7:167-173.
    • (2010) Clin Trials , vol.7 , pp. 167-173
    • Quinlan, J.1    Gaydos, B.2    Maca, J.3    Krams, M.4
  • 9
    • 33644597596 scopus 로고    scopus 로고
    • The continual reassessment method for dose-finding studies: a tutorial
    • Garrett-Mayer E. The continual reassessment method for dose-finding studies: a tutorial. Clin Trials 2006, 3:57-71.
    • (2006) Clin Trials , vol.3 , pp. 57-71
    • Garrett-Mayer, E.1
  • 10
    • 36248961734 scopus 로고    scopus 로고
    • Innovative approaches for designing and analyzing adaptive dose-ranging trials
    • Bornkamp B., Bretz F., Dmitrienko A., et al. Innovative approaches for designing and analyzing adaptive dose-ranging trials. J Biopharm Stat 2007, 17:965-995.
    • (2007) J Biopharm Stat , vol.17 , pp. 965-995
    • Bornkamp, B.1    Bretz, F.2    Dmitrienko, A.3
  • 11
    • 78449283356 scopus 로고    scopus 로고
    • Enrichment of clinical study populations
    • Temple R. Enrichment of clinical study populations. Clin Pharmacol Ther 2010, 88:774-778.
    • (2010) Clin Pharmacol Ther , vol.88 , pp. 774-778
    • Temple, R.1
  • 13
    • 33750854113 scopus 로고    scopus 로고
    • Adaptive seamless phase II/III designs: background operational aspects and examples
    • Maca J., Bhattacharya S., Dragalin V., Gallo P., Krams M., et al. Adaptive seamless phase II/III designs: background operational aspects and examples. Drug Inf J 2006, 40:463-473.
    • (2006) Drug Inf J , vol.40 , pp. 463-473
    • Maca, J.1    Bhattacharya, S.2    Dragalin, V.3    Gallo, P.4    Krams, M.5
  • 14
    • 84555178552 scopus 로고    scopus 로고
    • Seamless phase II/III designs
    • Stallard N., Todd S. Seamless phase II/III designs. Stat Methods Med Res 2010, 20:623-634.
    • (2010) Stat Methods Med Res , vol.20 , pp. 623-634
    • Stallard, N.1    Todd, S.2
  • 15
    • 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. Stat Med 1990, 9:65-72.
    • (1990) Stat Med , vol.9 , pp. 65-72
    • Wittes, J.1    Brittain, E.2
  • 16
    • 22044443101 scopus 로고    scopus 로고
    • Two-stage sample size re-estimation based on a nuisance parameter: a review
    • Proschan M.A. Two-stage sample size re-estimation based on a nuisance parameter: a review. JBS 2005, 15:559-574.
    • (2005) JBS , vol.15 , pp. 559-574
    • Proschan, M.A.1
  • 17
    • 66349091397 scopus 로고    scopus 로고
    • Sample size re-estimation in clinical trials
    • Proschan M.A. Sample size re-estimation in clinical trials. Biom J 2009, 51:348-357.
    • (2009) Biom J , vol.51 , pp. 348-357
    • Proschan, M.A.1
  • 18
    • 33646245937 scopus 로고    scopus 로고
    • Adaptive designs in clinical drug development - an executive summary of the PhRMA working group
    • Gallo P., Chuang-Stein C., Dragalin V., Gaydos B., Krams M., Pinheiro J. Adaptive designs in clinical drug development - an executive summary of the PhRMA working group. JBS 2009, 16:275-283.
    • (2009) JBS , vol.16 , pp. 275-283
    • Gallo, P.1    Chuang-Stein, C.2    Dragalin, V.3    Gaydos, B.4    Krams, M.5    Pinheiro, J.6
  • 20
    • 0028619850 scopus 로고
    • Evaluations of experiments with adaptive interim analyses
    • Bauer P., Kohne K. Evaluations of experiments with adaptive interim analyses. Biometrics 1994, 50:1029-1041.
    • (1994) Biometrics , vol.50 , pp. 1029-1041
    • Bauer, P.1    Kohne, K.2
  • 21
    • 0029589385 scopus 로고
    • Designed extension of studies based on conditional power
    • Proschan M.A., Hunsberger S.A. 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
  • 22
    • 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
  • 23
    • 0032886394 scopus 로고    scopus 로고
    • Modification of sample size in group sequential clinical trials
    • Chi L., Hung H.M.J., Wang S.J. Modification of sample size in group sequential clinical trials. Biometrics 1999, 55:853-857.
    • (1999) Biometrics , vol.55 , pp. 853-857
    • Chi, L.1    Hung, H.M.J.2    Wang, S.J.3
  • 24
    • 84864302069 scopus 로고    scopus 로고
    • Adaptive group sequential designs for clinical trials: combining the advantages of adaptive and classical group sequential approaches
    • Muller H.H., Schafer H. Adaptive group sequential designs for clinical trials: combining the advantages of adaptive and classical group sequential approaches. Biometrics 2001, 23:2497-2508.
    • (2001) Biometrics , vol.23 , pp. 2497-2508
    • Muller, H.H.1    Schafer, H.2
  • 25
    • 1842826262 scopus 로고    scopus 로고
    • On the inefficiency of the adaptive design for monitoring clinical trials
    • Tsiatis A.A., Mehta C. On the inefficiency of the adaptive design for monitoring clinical trials. Biometrika 2003, 90:367-378.
    • (2003) Biometrika , vol.90 , pp. 367-378
    • Tsiatis, A.A.1    Mehta, C.2
  • 26
    • 0037473229 scopus 로고    scopus 로고
    • Mid-course sample size modification in clinical trials based on the observed treatment effect
    • Jennison C., Turnbull B.W. Mid-course sample size modification in clinical trials based on the observed treatment effect. Stat Med 2003, 22:971-993.
    • (2003) Stat Med , vol.22 , pp. 971-993
    • Jennison, C.1    Turnbull, B.W.2
  • 27
    • 33644770078 scopus 로고    scopus 로고
    • Efficient group sequential designs when there are several effect sizes under consideration
    • Jennison C., Turnbull B.W. Efficient group sequential designs when there are several effect sizes under consideration. Stat Med 2006, 25:917-932.
    • (2006) Stat Med , vol.25 , pp. 917-932
    • Jennison, C.1    Turnbull, B.W.2
  • 28
    • 33748550685 scopus 로고    scopus 로고
    • Sample size recalculation in internal pilot study designs: a review
    • Friede T., Kieser M. Sample size recalculation in internal pilot study designs: a review. Biom J 2006, 48:537-555.
    • (2006) Biom J , vol.48 , pp. 537-555
    • Friede, T.1    Kieser, M.2
  • 29
    • 66349091397 scopus 로고    scopus 로고
    • Sample size re-estimation in clinical trials
    • Proschan M.A. Sample size re-estimation in clinical trials. Biometrics J 2009, 51:348-357.
    • (2009) Biometrics J , vol.51 , pp. 348-357
    • Proschan, M.A.1
  • 31
    • 0035892035 scopus 로고    scopus 로고
    • A comparison of warfarin and aspirin for the prevention of recurrent ischemic stroke
    • Mohr J.F., Thompson J.L.P., Lazar R.M., Levin B., Sacco R.L., Furie K.L., et al. A comparison of warfarin and aspirin for the prevention of recurrent ischemic stroke. N Engl J Med 2001, 345:1444-1451.
    • (2001) N Engl J Med , vol.345 , pp. 1444-1451
    • Mohr, J.F.1    Thompson, J.L.P.2    Lazar, R.M.3    Levin, B.4    Sacco, R.L.5    Furie, K.L.6
  • 33
    • 0020974571 scopus 로고
    • Sample size formula for the proportional hazards regression model
    • Schoenfeld D.A. 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
  • 34
    • 0028595559 scopus 로고
    • Internal pilot studies for estimating sample size
    • Birkett M.A., Day S.J. Internal pilot studies for estimating sample size. Stat Med 1994, 1994(13):15-30.
    • (1994) Stat Med , vol.1994 , Issue.13 , pp. 15-30
    • Birkett, M.A.1    Day, S.J.2
  • 35
    • 0348149055 scopus 로고    scopus 로고
    • Sample size re-estimation in group-sequential response-adaptive clinical trials
    • Morgan C.C. Sample size re-estimation in group-sequential response-adaptive clinical trials. Stat Med 2003, 22:3843-3857.
    • (2003) Stat Med , vol.22 , pp. 3843-3857
    • Morgan, C.C.1
  • 36
    • 0035739842 scopus 로고    scopus 로고
    • Flexible sample size considerations using information-based monitoring
    • Mehta C.R., Tsiatis A.A. Flexible sample size considerations using information-based monitoring. Drug Inf J 2001, 35:1095-1112.
    • (2001) Drug Inf J , vol.35 , pp. 1095-1112
    • Mehta, C.R.1    Tsiatis, A.A.2
  • 37
    • 77957148053 scopus 로고    scopus 로고
    • Combining internal pilots with an interim analysis for single degree of freedom tests
    • Kairalla J.A., Muller K.E., Coffey C.S. Combining internal pilots with an interim analysis for single degree of freedom tests. Commun Stat Theory Methods 2010, 39(20):3717-3738.
    • (2010) Commun Stat Theory Methods , vol.39 , Issue.20 , pp. 3717-3738
    • Kairalla, J.A.1    Muller, K.E.2    Coffey, C.S.3
  • 38
    • 80053314742 scopus 로고    scopus 로고
    • Efficiency perspectives on adaptive designs in stroke clinical trials
    • Cheung K., Kaufmann P. Efficiency perspectives on adaptive designs in stroke clinical trials. Stroke 2011, 42:2990-2994.
    • (2011) Stroke , vol.42 , pp. 2990-2994
    • Cheung, K.1    Kaufmann, P.2
  • 40
    • 33646596912 scopus 로고    scopus 로고
    • Aspirin plus dipyridamole versus aspirin alone after cerebral ischaemia of arterial origin (esprit): randomised controlled trial
    • Halkes P.H., van Gijn J., Kappelle L.J., Koudstaal P.J., Algra A. Aspirin plus dipyridamole versus aspirin alone after cerebral ischaemia of arterial origin (esprit): randomised controlled trial. Lancet 2006, 367:1665-1673.
    • (2006) Lancet , vol.367 , pp. 1665-1673
    • Halkes, P.H.1    van Gijn, J.2    Kappelle, L.J.3    Koudstaal, P.J.4    Algra, A.5
  • 41
    • 51449116270 scopus 로고    scopus 로고
    • Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke
    • Sacco R.L., Diener H.C., Yusuf S., Cotton D., Ounpuu S., Lawton W.A., et al. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke. N Engl J Med 2008, 359:1238-1251.
    • (2008) N Engl J Med , vol.359 , pp. 1238-1251
    • Sacco, R.L.1    Diener, H.C.2    Yusuf, S.3    Cotton, D.4    Ounpuu, S.5    Lawton, W.A.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.