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Volumn 5, Issue 2, 2006, Pages 119-124

Operational challenges in adaptive design implementation

Author keywords

Data monitoring Committee; Group sequential trial; Interim analysis; Sample size re estimation; Seamless trial

Indexed keywords

PLACEBO;

EID: 33745175516     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.221     Document Type: Review
Times cited : (31)

References (11)
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    • Bauer, P.1    Köhne, K.2
  • 2
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    • Adaptive group sequential designs for clinical trials: Combining the advantages of adaptive and classical group sequential approaches
    • Müller HH, Schäfer H. Adaptive group sequential designs for clinical trials: combining the advantages of adaptive and classical group sequential approaches. Biometrics 2001; 57:886-891.
    • (2001) Biometrics , vol.57 , pp. 886-891
    • Müller, H.H.1    Schäfer, H.2
  • 3
    • 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
  • 4
    • 0038739457 scopus 로고    scopus 로고
    • Improved repeated confidence bounds in trials with a maximal goal
    • Brannath W, König F, Bauer P. Improved repeated confidence bounds in trials with a maximal goal. Biometrical Journal 2003; 45:311-324.
    • (2003) Biometrical Journal , vol.45 , pp. 311-324
    • Brannath, W.1    König, F.2    Bauer, P.3
  • 7
    • 33745128497 scopus 로고    scopus 로고
    • Committee for Medicinal Products for Human Use. EMEA: London
    • Committee for Medicinal Products for Human Use. Guideline on Data Monitoring Committees. EMEA: London, 2005.
    • (2005) Guideline on Data Monitoring Committees
  • 8
    • 0000936017 scopus 로고    scopus 로고
    • ICH harmonised tripartite guideline: Statistical principles for clinical trials
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    • International Conference on Harmonisation Expert Working Group. ICH harmonised tripartite guideline: statistical principles for clinical trials. Federal Register 1998; 63:49583-49598.
    • (1998) Federal Register , vol.63 , pp. 49583-49598
  • 9
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    • Data monitoring committees in clinical trials: A practical perspective
    • Wiley: Chichester
    • Ellenberg SS, Fleming TR, DeMets DL. Data monitoring committees in clinical trials: a practical perspective. Wiley: Chichester, 2002.
    • (2002)
    • Ellenberg, S.S.1    Fleming, T.R.2    DeMets, D.L.3
  • 10
    • 0003801716 scopus 로고    scopus 로고
    • The design and analysis of sequential clinical trials
    • Wiley: Chichester
    • Whitehead J. The design and analysis of sequential clinical trials. Wiley: Chichester, 1997.
    • (1997)
    • Whitehead, J.1
  • 11
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    • Reflection paper on methodological issues in confirmatory clinical trials with flexible design and analysis plans
    • Committee for Medicinal Products for Human Use. (Draft). EMEA: London
    • Committee for Medicinal Products for Human Use. Reflection paper on methodological issues in confirmatory clinical trials with flexible design and analysis plans. (Draft). EMEA: London; 2006.
    • (2006)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.