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Volumn 10, Issue 1, 2013, Pages 63-80

Small-sample behavior of novel phase i cancer trial designs

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BAYES THEOREM; DOSE CALCULATION; DRUG TOXICITY; MAXIMUM TOLERATED DOSE; PHASE 1 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROBABILITY; PUBLICATION; STUDY DESIGN;

EID: 84872858984     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774512469311     Document Type: Article
Times cited : (30)

References (57)
  • 1
    • 0025148278 scopus 로고
    • Continual reassessment method: A practical design for phase i clinical trials in cancer
    • O'Quigley J, Pepe M, Fisher L. Continual reassessment method: A practical design for phase I clinical trials in cancer. Biometrics. 1990 ; 46 (1). 33-48
    • (1990) Biometrics , vol.46 , Issue.1 , pp. 33-48
    • O'Quigley, J.1    Pepe, M.2    Fisher, L.3
  • 2
    • 0031920799 scopus 로고    scopus 로고
    • Cancer phase i clinical trials: Efficient dose escalation with overdose control
    • Babb J, Rogatko A, Zacks S. Cancer phase I clinical trials: Efficient dose escalation with overdose control. Stat Med. 1998 ; 17: 1103-20
    • (1998) Stat Med , vol.17 , pp. 1103-1120
    • Babb, J.1    Rogatko, A.2    Zacks, S.3
  • 3
    • 0035075179 scopus 로고    scopus 로고
    • Isotonic designs for phase i trials
    • Leung DHY, Wang YG. Isotonic designs for phase I trials. Control Clin Trials. 2001 ; 22 (2). 126-38
    • (2001) Control Clin Trials , vol.22 , Issue.2 , pp. 126-138
    • Dhy, L.1    Wang, Y.G.2
  • 4
    • 33644632237 scopus 로고    scopus 로고
    • Isotonic designs for phase i cancer clinical trials with multiple risk groups
    • Yuan Z, Chappell R. Isotonic designs for phase I cancer clinical trials with multiple risk groups. Clin Trials. 2004 ; 1 (6). 499-508
    • (2004) Clin Trials , vol.1 , Issue.6 , pp. 499-508
    • Yuan, Z.1    Chappell, R.2
  • 7
    • 0024452804 scopus 로고
    • Design and analysis of phase i clinical trials
    • Storer BE. Design and analysis of phase I clinical trials. Biometrics. 1989 ; 45 (3). 925-37
    • (1989) Biometrics , vol.45 , Issue.3 , pp. 925-937
    • Storer, B.E.1
  • 8
    • 0032648126 scopus 로고    scopus 로고
    • Operating characteristics of the standard phase i clinical trial design
    • Reiner E, Paoletti X, O'Quigley J. Operating characteristics of the standard phase I clinical trial design. Comput Stat Data An. 1999 ; 30: 303-15
    • (1999) Comput Stat Data An , vol.30 , pp. 303-315
    • Reiner, E.1    Paoletti, X.2    O'Quigley, J.3
  • 9
    • 0012957270 scopus 로고    scopus 로고
    • Statistical properties of the traditional algorithm-based designs for phase i cancer clinical trials
    • Lin Y, Shih WJ. Statistical properties of the traditional algorithm-based designs for phase I cancer clinical trials. Biostatistics. 2001 ; 2 (2). 203-15
    • (2001) Biostatistics , vol.2 , Issue.2 , pp. 203-215
    • Lin, Y.1    Shih, W.J.2
  • 10
    • 36849035490 scopus 로고    scopus 로고
    • Translation of innovative designs into phase i trials
    • Rogatko A, Schoeneck D, Jonas W, et al. Translation of innovative designs into phase I trials. J Clin Oncol. 2007 ; 25 (31). 4982-86
    • (2007) J Clin Oncol , vol.25 , Issue.31 , pp. 4982-4986
    • Rogatko, A.1    Schoeneck, D.2    Jonas, W.3
  • 11
    • 77949699034 scopus 로고    scopus 로고
    • Approaches to phase 1 clinical trial design focused on safety, efficiency, and selected patient populations: A report from the clinical trial design task force of the National Cancer Institute Investigational Drug Steering Committee
    • Ivy SP, Siu LL, Garrett-Mayer E, Rubinstein L. Approaches to phase 1 clinical trial design focused on safety, efficiency, and selected patient populations: A report from the clinical trial design task force of the National Cancer Institute Investigational Drug Steering Committee. Clin Cancer Res. 2010 ; 16 (6). 1726-36
    • (2010) Clin Cancer Res , vol.16 , Issue.6 , pp. 1726-1736
    • Ivy, S.P.1    Siu, L.L.2    Garrett-Mayer, E.3    Rubinstein, L.4
  • 12
    • 33746402001 scopus 로고    scopus 로고
    • Consistency of continual reassessment method under model misspecification
    • Shen LZ, O'Quigley J. Consistency of continual reassessment method under model misspecification. Biometrika. 1996 ; 83 (2). 395-405
    • (1996) Biometrika , vol.83 , Issue.2 , pp. 395-405
    • Shen, L.Z.1    O'Quigley, J.2
  • 13
    • 0036712359 scopus 로고    scopus 로고
    • A simple technique to evaluate model sensitivity in the continual reassessment method
    • Cheung YK, Chappell R. A simple technique to evaluate model sensitivity in the continual reassessment method. Biometrics. 2002 ; 58 (3). 671-74
    • (2002) Biometrics , vol.58 , Issue.3 , pp. 671-674
    • Cheung, Y.K.1    Chappell, R.2
  • 14
    • 67649321803 scopus 로고    scopus 로고
    • Model calibration in the continual reassessment method
    • Lee SM, Cheung YK. Model calibration in the continual reassessment method. Clin Trials. 2009 ; 6: 227-38
    • (2009) Clin Trials , vol.6 , pp. 227-238
    • Lee, S.M.1    Cheung, Y.K.2
  • 15
    • 80455130105 scopus 로고    scopus 로고
    • Dose-finding designs: The role of convergence properties
    • Oron AP, Azriel D, Hoff PD. Dose-finding designs: The role of convergence properties. Int J Biostat. 2011 ; 7 (1). 39
    • (2011) Int J Biostat , vol.7 , Issue.1 , pp. 39
    • Oron, A.P.1    Azriel, D.2    Hoff, P.D.3
  • 16
    • 84857254452 scopus 로고    scopus 로고
    • A note on the robustness of the continual reassessment method
    • Azriel D. A note on the robustness of the continual reassessment method. Stat Probab Lett. 2012 ; 82: 902-06
    • (2012) Stat Probab Lett , vol.82 , pp. 902-906
    • Azriel, D.1
  • 17
    • 79954622444 scopus 로고    scopus 로고
    • The treatment versus experimentation dilemma in dose finding studies
    • Azriel D, Mandel M, Rinott Y. The treatment versus experimentation dilemma in dose finding studies. J Stat Plan Inference. 2011 ; 141 (8). 2759-68
    • (2011) J Stat Plan Inference , vol.141 , Issue.8 , pp. 2759-2768
    • Azriel, D.1    Mandel, M.2    Rinott, Y.3
  • 18
    • 44949143122 scopus 로고    scopus 로고
    • Critical aspects of the Bayesian approach to phase i cancer trials
    • Neuenschwander B, Branson M, Gsponer T. Critical aspects of the Bayesian approach to phase I cancer trials. Stat Med. 2008 ; 27: 2420-39
    • (2008) Stat Med , vol.27 , pp. 2420-2439
    • Neuenschwander, B.1    Branson, M.2    Gsponer, T.3
  • 19
    • 61449307103 scopus 로고    scopus 로고
    • Adaptive designs for dose-finding in non-cancer phase II trials: Influence of early unexpected outcomes
    • Resche-Rigon M, Zohar S, Chevret S. Adaptive designs for dose-finding in non-cancer phase II trials: Influence of early unexpected outcomes. Clin Trials. 2008 ; 5: 595-606
    • (2008) Clin Trials , vol.5 , pp. 595-606
    • Resche-Rigon, M.1    Zohar, S.2    Chevret, S.3
  • 20
    • 84872846359 scopus 로고    scopus 로고
    • Using the continual reassessment method to estimate the minimum effective dose in phase II dose-finding studies: A case study
    • Zohar S, Resche-Rigon M, Chevret S. Using the continual reassessment method to estimate the minimum effective dose in phase II dose-finding studies: A case study. Clin Trials. 2011 ;:
    • (2011) Clin Trials
    • Zohar, S.1    Resche-Rigon, M.2    Chevret, S.3
  • 21
    • 59349088647 scopus 로고    scopus 로고
    • A comprehensive comparison of the continual reassessment method to the standard 3+3 dose escalation scheme in phase i dose-finding studies
    • Iasonos A, Wilton AS, Riedel ER, Seshan VE, Spriggs DR. A comprehensive comparison of the continual reassessment method to the standard 3+3 dose escalation scheme in phase I dose-finding studies. Clin Trials. 2008 ; 5: 465-77
    • (2008) Clin Trials , vol.5 , pp. 465-477
    • Iasonos, A.1    Wilton, A.S.2    Riedel, E.R.3    Seshan, V.E.4    Spriggs, D.R.5
  • 22
    • 0027319907 scopus 로고
    • The continual reassessment method in cancer phase i clinical trials: A simulation study
    • Chevret S. The continual reassessment method in cancer phase I clinical trials: A simulation study. Stat Med. 1993 ; 12: 1093-108
    • (1993) Stat Med , vol.12 , pp. 1093-1108
    • Chevret, S.1
  • 23
    • 33644840022 scopus 로고    scopus 로고
    • Experimental designs for phase i and phase I/II dose-finding studies
    • O'Quigley J, Zohar S. Experimental designs for phase I and phase I/II dose-finding studies. Br J Cancer. 2006 ; 94 (5). 609-13
    • (2006) Br J Cancer , vol.94 , Issue.5 , pp. 609-613
    • O'Quigley, J.1    Zohar, S.2
  • 25
    • 0029071328 scopus 로고
    • Bayesian decision procedures for dose determining experiments
    • Whitehead J, Brunier H. Bayesian decision procedures for dose determining experiments. Stat Med. 1995 ; 14: 885-93
    • (1995) Stat Med , vol.14 , pp. 885-893
    • Whitehead, J.1    Brunier, H.2
  • 26
    • 0002434647 scopus 로고    scopus 로고
    • Easy-to-implement Bayesian methods for dose-escalation studies in healthy volunteers
    • Whitehead J, Patterson S, Webber D, Francis S, Zhou Y. Easy-to-implement Bayesian methods for dose-escalation studies in healthy volunteers. Biostatistics. 2001 ; 2: 47-61
    • (2001) Biostatistics , vol.2 , pp. 47-61
    • Whitehead, J.1    Patterson, S.2    Webber, D.3    Francis, S.4    Zhou, Y.5
  • 27
    • 0033745652 scopus 로고    scopus 로고
    • A dose-finding study of liposomal daunorubicin with CVP (COP-X) in advanced NHL
    • Flinn IW, Goodman SN, Post L, et al. A dose-finding study of liposomal daunorubicin with CVP (COP-X) in advanced NHL. Ann Oncol. 2000 ; 11: 691-95
    • (2000) Ann Oncol , vol.11 , pp. 691-695
    • Flinn, I.W.1    Goodman, S.N.2    Post, L.3
  • 28
    • 0034111174 scopus 로고    scopus 로고
    • Maximum tolerated dose of nalmefene in patients receiving epidural fentanyl and dilute bupivacaine for postoperative analgesia
    • Dougherty TB, Porche VH, Thall PF. Maximum tolerated dose of nalmefene in patients receiving epidural fentanyl and dilute bupivacaine for postoperative analgesia. Anesthesiology. 2000 ; 92: 1010-16
    • (2000) Anesthesiology , vol.92 , pp. 1010-1016
    • Dougherty, T.B.1    Porche, V.H.2    Thall, P.F.3
  • 29
    • 0029027770 scopus 로고
    • Some practical improvements in the continual reassessment method for phase i studies
    • Goodman SN, Zahurak ML, Piantadosi S. Some practical improvements in the continual reassessment method for phase I studies. Stat Med. 1995 ; 14: 1149-61
    • (1995) Stat Med , vol.14 , pp. 1149-1161
    • Goodman, S.N.1    Zahurak, M.L.2    Piantadosi, S.3
  • 30
    • 4344632232 scopus 로고    scopus 로고
    • Phase i trial of preoperative doxorubicin-based concurrent chemoradiation and surgical resection for localized extremity and body wall soft tissue sarcomas
    • Pisters PW, Patel SR, Prieto VG, et al. Phase I trial of preoperative doxorubicin-based concurrent chemoradiation and surgical resection for localized extremity and body wall soft tissue sarcomas. J Clin Oncol. 2004 ; 22 (16). 3375-80
    • (2004) J Clin Oncol , vol.22 , Issue.16 , pp. 3375-3380
    • Pisters, P.W.1    Patel, S.R.2    Prieto, V.G.3
  • 31
    • 4344717475 scopus 로고    scopus 로고
    • Platelet-derived growth factor receptor inhibitor imatinib mesylate and docetaxel: A modular phase i trial in androgen-independent prostate cancer
    • Mathew P, Thall PF, Jones D, et al. Platelet-derived growth factor receptor inhibitor imatinib mesylate and docetaxel: A modular phase I trial in androgen-independent prostate cancer. J Clin Oncol. 2004 ; 22 (16). 3323-29
    • (2004) J Clin Oncol , vol.22 , Issue.16 , pp. 3323-3329
    • Mathew, P.1    Thall, P.F.2    Jones, D.3
  • 32
    • 27944494441 scopus 로고    scopus 로고
    • Coherence principles in dose-finding studies
    • Cheung YK. Coherence principles in dose-finding studies. Biometrika. 2005 ; 92 (4). 863-73
    • (2005) Biometrika , vol.92 , Issue.4 , pp. 863-873
    • Cheung, Y.K.1
  • 33
    • 0346578679 scopus 로고
    • Theory and practice of Bayesian statistics
    • Lindley DV. Theory and practice of Bayesian statistics. Statistician. 1983 ; 32: 1-11
    • (1983) Statistician , vol.32 , pp. 1-11
    • Lindley, D.V.1
  • 34
    • 84947406205 scopus 로고
    • A method for obtaining and analyzing sensitivity data
    • Dixon WJ, Mood AM. A method for obtaining and analyzing sensitivity data. J Am Stat Assoc. 1948 ; 43: 109-26
    • (1948) J Am Stat Assoc , vol.43 , pp. 109-126
    • Dixon, W.J.1    Mood, A.M.2
  • 35
    • 0012465236 scopus 로고
    • Non-parametric up-and-down experimentation
    • Derman C. Non-parametric up-and-down experimentation. Ann Math Stat. 1957 ; 28: 795-98
    • (1957) Ann Math Stat , vol.28 , pp. 795-798
    • Derman, C.1
  • 36
    • 0012357746 scopus 로고
    • Random walk design in bio-assay
    • Tsutakawa RK. Random walk design in bio-assay. J Am Stat Assoc. 1967 ; 62: 842-56
    • (1967) J Am Stat Assoc , vol.62 , pp. 842-856
    • Tsutakawa, R.K.1
  • 37
    • 0012357748 scopus 로고
    • Flournoy N Rosenberger WF, ed. Hayward, CA: Institute of Mathematical Statistics;
    • Durham SD, Flournoy N Adaptive Designs. Flournoy N Rosenberger WF, ed. Hayward, CA: Institute of Mathematical Statistics ; 1995: 139-57.
    • (1995) Adaptive Designs , pp. 139-157
    • Durham, S.D.1    Flournoy, N.2
  • 39
    • 0036191646 scopus 로고    scopus 로고
    • Dose finding using the biased coin up-and-down design and isotonic regression
    • Stylianou M, Flournoy N. Dose finding using the biased coin up-and-down design and isotonic regression. Biometrics. 2002 ; 58 (1). 171-77
    • (2002) Biometrics , vol.58 , Issue.1 , pp. 171-177
    • Stylianou, M.1    Flournoy, N.2
  • 41
    • 69949108832 scopus 로고    scopus 로고
    • The k-in-a-row up-and-down design, revisited
    • Oron AP, Hoff PD. The k-in-a-row up-and-down design, revisited. Stat Med. 2009 ; 28: 1805-20
    • (2009) Stat Med , vol.28 , pp. 1805-1820
    • Oron, A.P.1    Hoff, P.D.2
  • 42
    • 32044468998 scopus 로고    scopus 로고
    • Group up-and-down designs for dose-finding
    • Gezmu M, Flournoy N. Group up-and-down designs for dose-finding. J Stat Plan Inference. 2006 ; 136 (6). 1749-64
    • (2006) J Stat Plan Inference , vol.136 , Issue.6 , pp. 1749-1764
    • Gezmu, M.1    Flournoy, N.2
  • 46
    • 32044440133 scopus 로고    scopus 로고
    • Theoretical study of the continual reassessment method
    • O'Quigley J. Theoretical study of the continual reassessment method. J Stat Plan Inference. 2006 ; 136: 1765-80
    • (2006) J Stat Plan Inference , vol.136 , pp. 1765-1780
    • O'Quigley, J.1
  • 47
    • 0035888182 scopus 로고    scopus 로고
    • The continual reassessment method: Comparison of Bayesian stopping rules for dose-ranging studies
    • Zohar S, Chevret S. The continual reassessment method: Comparison of Bayesian stopping rules for dose-ranging studies. Stat Med. 2003 ; 20: 2827-43
    • (2003) Stat Med , vol.20 , pp. 2827-2843
    • Zohar, S.1    Chevret, S.2
  • 50
    • 34548619360 scopus 로고    scopus 로고
    • Dose-finding in phase i clinical trials based on toxicity probability intervals
    • Ji Y, Li Y, Bekele BN. Dose-finding in phase I clinical trials based on toxicity probability intervals. Clin Trials. 2007 ; 4 (3). 235-44
    • (2007) Clin Trials , vol.4 , Issue.3 , pp. 235-244
    • Ji, Y.1    Li, Y.2    Bekele, B.N.3
  • 51
    • 78650322746 scopus 로고    scopus 로고
    • A modified toxicity probability interval method for dose-finding trials
    • Ji Y, Li Y, Bekele BN. A modified toxicity probability interval method for dose-finding trials. Clin Trials. 2007 ; 7: 653-63
    • (2007) Clin Trials , vol.7 , pp. 653-663
    • Ji, Y.1    Li, Y.2    Bekele, B.N.3
  • 52
    • 70349776681 scopus 로고    scopus 로고
    • Bayesian model averaging continual reassessment method in phase i clinical trials
    • Yin G, Yuan Y. Bayesian model averaging continual reassessment method in phase I clinical trials. J Am Stat Assoc. 2009 ; 104: 954-68
    • (2009) J Am Stat Assoc , vol.104 , pp. 954-968
    • Yin, G.1    Yuan, Y.2
  • 53
    • 78650233226 scopus 로고    scopus 로고
    • Approximate dynamic programming and its applications to the design of phase i cancer trials
    • Bartroff J, Lai TL. Approximate dynamic programming and its applications to the design of phase I cancer trials. Stat Sci. 2010 ; 25: 245-57
    • (2010) Stat Sci , vol.25 , pp. 245-257
    • Bartroff, J.1    Lai, T.L.2
  • 54
    • 34250811955 scopus 로고    scopus 로고
    • Advances in and limitations of up-and-down methodology: A précis of clinical use, study design, and dose estimation in anesthesia research
    • Pace NL, Stylianou MP. Advances in and limitations of up-and-down methodology: A précis of clinical use, study design, and dose estimation in anesthesia research. Anesthesiology. 2007 ; 107 (1). 144-52
    • (2007) Anesthesiology , vol.107 , Issue.1 , pp. 144-152
    • Pace, N.L.1    Stylianou, M.P.2
  • 55
    • 0025986460 scopus 로고
    • Methods for dose finding studies in cancer clinical trials - A review of a Monte-Carlo study
    • O'Quigley J, Chevret S. Methods for dose finding studies in cancer clinical trials - A review of a Monte-Carlo study. Stat Med. 1991 ; 10 (11). 1647-64
    • (1991) Stat Med , vol.10 , Issue.11 , pp. 1647-1664
    • O'Quigley, J.1    Chevret, S.2
  • 56
    • 0035974939 scopus 로고    scopus 로고
    • An evaluation of Phase i clinical trial designs in the continuous dose-response setting
    • Storer BE. An evaluation of Phase I clinical trial designs in the continuous dose-response setting. Stat Med. 2001 ; 20: 2399-408
    • (2001) Stat Med , vol.20 , pp. 2399-2408
    • Storer, B.E.1
  • 57
    • 0000090155 scopus 로고
    • Sequential tests of statistical hypotheses
    • Wald A. Sequential tests of statistical hypotheses. Ann Math Stat. 1945 ; 16 (2). 117-86
    • (1945) Ann Math Stat , vol.16 , Issue.2 , pp. 117-186
    • Wald, A.1


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