메뉴 건너뛰기




Volumn 10, Issue 1, 2011, Pages 8-13

Blinded sample size recalculation for clinical trials with normal data and baseline adjusted analysis

Author keywords

analysis of covariance; baseline adjustment; baseline variables; clinical trials; internal pilot study; sample size recalculation

Indexed keywords

ANALYSIS OF COVARIANCE; ARTICLE; CALCULATION; CLINICAL TRIAL (TOPIC); ERROR; PILOT STUDY; SAMPLE SIZE; SIMULATION;

EID: 79551548989     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.398     Document Type: Article
Times cited : (28)

References (22)
  • 1
    • 79551517108 scopus 로고    scopus 로고
    • Committee for Proprietary Medicinal Products (CPMP) accessed 31.03.
    • Committee for Proprietary Medicinal Products (CPMP): Points to Consider on Adjustment for Baseline Covariates, 2003. Available at: http://www.emea. europa.eu/pdfs/human/ewp/286399en.pdf (accessed 31.03. 2009).
    • (2009) Points to Consider on Adjustment for Baseline Covariates, 2003
  • 5
    • 79551537348 scopus 로고    scopus 로고
    • accessed 31.03
    • Pass 2008 NCSS: Kaysville Available at: http://www.ncss.com/pass.html (accessed 31.03. 2009).
    • (2009) Pass 2008 NCSS: Kaysville
  • 6
    • 79551538092 scopus 로고    scopus 로고
    • Â Release 7.0
    • accessed 31.03
    • Â Release 7.0. Statistical Solutions: Saugus Available at: (accessed 31.03. 2009).
    • (2009) Statistical Solutions: Saugus
  • 9
    • 33644769837 scopus 로고    scopus 로고
    • Common threads between sample size recalculation and group sequential procedures
    • Schwartz TA, Denne JS,. Common threads between sample size recalculation and group sequential procedures. Pharmaceutical Statistics 2003; 2: 263-271.
    • (2003) Pharmaceutical Statistics , vol.2 , pp. 263-271
    • Schwartz, T.A.1    Denne, J.S.2
  • 10
    • 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. Biometrical Journal 2006; 48: 537-555.
    • (2006) Biometrical Journal , vol.48 , pp. 537-555
    • Friede, T.1    Kieser, M.2
  • 11
    • 66349091397 scopus 로고    scopus 로고
    • Sample size re-estimation in clinical trials
    • Proschan MA,. Sample size re-estimation in clinical trials. Biometrical Journal 2009; 51: 348-357.
    • (2009) Biometrical Journal , vol.51 , pp. 348-357
    • Proschan, M.A.1
  • 12
    • 0033619975 scopus 로고    scopus 로고
    • Internal pilot studies II: Comparison of various procedures
    • DOI 10.1 002/(SICI)1 097-0258(1999 1230)18:24<34 93::AID-SIM302>3. 0.CO;2-2
    • Zucker DM, Wittes JT, Schabenberger O, Brittain E,. Internal pilot studies II: comparison of various procedures. Statistics in Medicine 1999; 18: 3493-3509. (Pubitemid 30041362)
    • (1999) Statistics in Medicine , vol.18 , Issue.24 , pp. 3493-3509
    • Zucker, D.M.1    Wittes, J.T.2    Schabenberger, O.3    Brittain, E.4
  • 13
    • 0345329168 scopus 로고    scopus 로고
    • Simple procedures for blinded sample size recalculation that do not affect the type i error rate
    • Kieser M, Friede T,. Simple procedures for blinded sample size recalculation that do not affect the type I error rate. Statistics in Medicine 2003; 22: 3571-3581.
    • (2003) Statistics in Medicine , vol.22 , pp. 3571-3581
    • Kieser, M.1    Friede, T.2
  • 14
    • 33947418116 scopus 로고    scopus 로고
    • Assessment of the Gould-Shih procedure for sample size re-estimation
    • Waksman JA,. Assessment of the Gould-Shih procedure for sample size re-estimation. Pharmaceutical Statistics 2007; 6: 53-65.
    • (2007) Pharmaceutical Statistics , vol.6 , pp. 53-65
    • Waksman, J.A.1
  • 15
    • 0033617687 scopus 로고    scopus 로고
    • Exact test size and power of a Gaussian error linear model for an internal pilot study
    • Coffey CS, Muller KE,. Exact test size and power of a Gaussian error linear model for an internal pilot study. Statistics in Medicine 1999; 18: 1199-1214.
    • (1999) Statistics in Medicine , vol.18 , pp. 1199-1214
    • Coffey, C.S.1    Muller, K.E.2
  • 16
    • 0026445783 scopus 로고    scopus 로고
    • Repeated measures in clinical trials: Analysis using mean summary statistics and its implications for design
    • Frison L, Pocock SJ,. Repeated measures in clinical trials: analysis using mean summary statistics and its implications for design. Statistics in Medicine 1999; 11: 1685-1704.
    • (1999) Statistics in Medicine , vol.11 , pp. 1685-1704
    • Frison, L.1    Pocock, S.J.2
  • 17
    • 0000985097 scopus 로고
    • Sample size formulae for normal theory t-tests
    • Guenther WC,. Sample size formulae for normal theory t-tests. American Statistician 1981; 35: 243-244.
    • (1981) American Statistician , vol.35 , pp. 243-244
    • Guenther, W.C.1
  • 18
    • 0033555868 scopus 로고    scopus 로고
    • Sample size formula with a continuous outcome, for unequal group size and unequal variances
    • Schouten HJA,. Sample size formula with a continuous outcome, for unequal group size and unequal variances. Statistics in Medicine 1999; 18: 87-91.
    • (1999) Statistics in Medicine , vol.18 , pp. 87-91
    • Schouten, H.J.A.1
  • 19
    • 0041565410 scopus 로고    scopus 로고
    • Adjusting power for a baseline covariate in linear models
    • Glueck DH, Muller KE,. Adjusting power for a baseline covariate in linear models. Statistics in Medicine 2003; 22: 2535-2551.
    • (2003) Statistics in Medicine , vol.22 , pp. 2535-2551
    • Glueck, D.H.1    Muller, K.E.2
  • 20
    • 0035977436 scopus 로고    scopus 로고
    • A comparison of methods for adaptive sample size adjustment
    • Friede T, Kieser M,. A comparison of methods for adaptive sample size adjustment. Statistics in Medicine 2001; 20: 3861-3873.
    • (2001) Statistics in Medicine , vol.20 , pp. 3861-3873
    • Friede, T.1    Kieser, M.2
  • 21
    • 25444530723 scopus 로고    scopus 로고
    • Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis
    • Rog DJ, Nurmikko TJ, Friede T, Young CA,. Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. Neurology 2005; 65: 812-819.
    • (2005) Neurology , vol.65 , pp. 812-819
    • Rog, D.J.1    Nurmikko, T.J.2    Friede, T.3    Young, C.A.4
  • 22
    • 46449085343 scopus 로고    scopus 로고
    • Issues with using baseline in last observation carried forward analysis
    • Julious SA, Mullee MA,. Issues with using baseline in last observation carried forward analysis. Pharmaceutical Statistics 2008; 7: 142-146.
    • (2008) Pharmaceutical Statistics , vol.7 , pp. 142-146
    • Julious, S.A.1    Mullee, M.A.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.