메뉴 건너뛰기




Volumn 7, Issue 2, 2010, Pages 121-135

A Bayesian dose-finding trial with adaptive dose expansion to flexibly assess efficacy and safety of an investigational drug

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; NEW DRUG; PLACEBO; ANTIDIABETIC AGENT;

EID: 77953678752     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774510361541     Document Type: Article
Times cited : (36)

References (16)
  • 1
    • 39649084919 scopus 로고    scopus 로고
    • The FDA critical path initiative and its influence on new drug development
    • Woodcock J, Woosley R. The FDA critical path initiative and its influence on new drug development. Annu Rev Med 2008; 59: 1-12.
    • (2008) Annu Rev Med , vol.59 , pp. 1-12
    • Woodcock, J.1    Woosley, R.2
  • 2
    • 4344645978 scopus 로고    scopus 로고
    • Can the pharmaceutical industry reduce attrition rates?
    • Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 2004; 3: 711-715.
    • (2004) Nat Rev Drug Discov , vol.3 , pp. 711-715
    • Kola, I.1    Landis, J.2
  • 3
    • 44649133246 scopus 로고    scopus 로고
    • A perspective on characterizing benefits and risks derived from clinical trials: Can we do more?
    • O'Neill RT. A perspective on characterizing benefits and risks derived from clinical trials: Can we do more? Drug Inf J 2008;42: 235-245.
    • Drug Inf J 2008 , vol.42 , pp. 235-245
    • O'Neill, R.T.1
  • 4
    • 33750854903 scopus 로고    scopus 로고
    • Adaptive designs: Terminology and classifi-cation
    • Dragalin V. Adaptive designs: Terminology and classifi-cation. Drug Inf J 2006; 40: 425-435.
    • (2006) Drug Inf J , vol.40 , pp. 425-435
    • Dragalin, V.1
  • 5
    • 0012838924 scopus 로고    scopus 로고
    • Adaptive Bayesian designs for dose-ranging drug trials
    • Gatsonis C, Carlin B, Carriquiry A. (eds) Springer, New York
    • Berry DA, Müller P, Grieve AP, et al. Adaptive Bayesian designs for dose-ranging drug trials. In Gatsonis C, Carlin B, Carriquiry A. (eds). Case Studies in Bayesian Statistics. V. Springer, New York, 2001, pp. 99-181.
    • (2001) Case Studies in Bayesian Statistics. V. , pp. 99-181
    • Berry, D.A.1    Müller, P.2    Grieve, A.P.3
  • 6
    • 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. JBiopharm Stat2007; 17: 965-995.
    • (2007) JBiopharm Stat , vol.17 , pp. 965-995
    • Bornkamp, B.1    Bretz, F.2    Dmitrienko, A.3
  • 7
    • 33745956991 scopus 로고    scopus 로고
    • An adaptive dose-finding design incorporating both toxicity and efficacy
    • Zhang W, Sargent D, Mandrekar S. An adaptive dose-finding design incorporating both toxicity and efficacy. Stat Med 2006; 25: 2365-83.
    • (2006) Stat Med , vol.25 , pp. 2365-83
    • Zhang, W.1    Sargent, D.2    Mandrekar, S.3
  • 8
    • 20744435134 scopus 로고    scopus 로고
    • A Bayesian Approach to jointly modeling toxicity and biomarker expression in a phase I/II dose-finding trial
    • Bekele BN, Shen Y. A Bayesian Approach to jointly modeling toxicity and biomarker expression in a phase I/II dose-finding trial. Biometrics 2005; 61: 343-354.
    • (2005) Biometrics , vol.61 , pp. 343-354
    • Bekele, B.N.1    Shen, Y.2
  • 9
    • 32044450843 scopus 로고    scopus 로고
    • Adaptive designs for dose-finding based on efficacy-toxicity response
    • Dragalin V, Fedorov V. Adaptive designs for dose-finding based on efficacy-toxicity response. J Stat Plan Infer 2006; 36: 1800-1823.
    • (2006) J Stat Plan Infer , vol.36 , pp. 1800-1823
    • Dragalin, V.1    Fedorov, V.2
  • 10
    • 0036277621 scopus 로고    scopus 로고
    • The bivariate continual reassessment method: Extending the CRM to phase i trials of two competing outcomes
    • Braun TM. The bivariate continual reassessment method: extending the CRM to phase I trials of two competing outcomes. Control Clin Trials 2002; 23: 240-256.
    • (2002) Control Clin Trials , vol.23 , pp. 240-256
    • Braun, T.M.1
  • 11
    • 36248936689 scopus 로고    scopus 로고
    • Dose finding designs for continuous responses and binary utility
    • Fedorov V, Wu Y. Dose finding designs for continuous responses and binary utility. J Biopharm Stat 2007; 17: 1085-1096.
    • (2007) J Biopharm Stat , vol.17 , pp. 1085-1096
    • Fedorov, V.1    Wu, Y.2
  • 12
    • 0031953966 scopus 로고    scopus 로고
    • A strategy for dose-finding and safety monitoring based on efficacy and adverse out-comes in phase I/II clinical trials
    • Thall PF, Russell KE. A strategy for dose-finding and safety monitoring based on efficacy and adverse out-comes in phase I/II clinical trials. Biometrics 1998; 54: 251-264.
    • (1998) Biometrics , vol.54 , pp. 251-264
    • Thall, P.F.1    Russell, K.E.2
  • 13
    • 4444272419 scopus 로고    scopus 로고
    • Dose-finding based on efficacy-toxicity trade-offs
    • Thall PF, Cook JD. Dose-finding based on efficacy-toxicity trade-offs. Biometrics 2004; 60: 684-693.
    • (2004) Biometrics , vol.60 , pp. 684-693
    • Thall, P.F.1    Cook, J.D.2
  • 14
    • 4444252640 scopus 로고    scopus 로고
    • Optimal designs and limiting optimal designs for a trinomial response
    • Fan SK, Chaloner K. Optimal designs and limiting optimal designs for a trinomial response. J Stat Plan Infer 2004; 126: 347-360.
    • (2004) J Stat Plan Infer , vol.126 , pp. 347-360
    • Fan, S.K.1    Chaloner, K.2
  • 15
    • 0033637096 scopus 로고    scopus 로고
    • Sequential designs for phase i clinical trials with late-onset toxicities
    • Cheung YK, Chappell R. Sequential designs for phase I clinical trials with late-onset toxicities. Biometrics 2000; 56: 1177-1182.
    • (2000) Biometrics , vol.56 , pp. 1177-1182
    • Cheung, Y.K.1    Chappell, R.2
  • 16
    • 0242694372 scopus 로고    scopus 로고
    • ASTIN: An adaptive dose-response study of UK-279,276 in acute ischemic stroke
    • Krams M, Lees KR, Hacke W, et al. ASTIN: An adaptive dose-response study of UK-279,276 in acute ischemic stroke. Stroke 2003; 34: 2543-2548.
    • (2003) Stroke , vol.34 , pp. 2543-2548
    • Krams, M.1    Lees, K.R.2    Hacke, W.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.