메뉴 건너뛰기




Volumn 3, Issue 4, 2014, Pages

Adaptive clinical trial designs in oncology

Author keywords

Adaptive design; Adaptive randomization; Biomarker guided design; Interim analysis; Seamless design

Indexed keywords


EID: 84941349403     PISSN: 23043865     EISSN: 23043873     Source Type: Journal    
DOI: 10.3978/j.issn.2304-3865.2014.06.04     Document Type: Review
Times cited : (38)

References (102)
  • 3
    • 84960429129 scopus 로고    scopus 로고
    • Available online
    • Bio/BioMedTracker. Clinical Trial Success Rates Study, 2011. Available online: http://insidebioia.files.wordpress.com/2011/02/bio-ceo-biomedtracker-bio-study-handout-final-2-15-2011.pdf
    • (2011) Clinical Trial Success Rates Study
  • 4
    • 24944527868 scopus 로고    scopus 로고
    • FDA introduction comments: clinical studies design and evaluation issues
    • Woodcock J. FDA introduction comments: clinical studies design and evaluation issues. Clinical trials 2005;2:273-5.
    • (2005) Clinical trials , vol.2 , pp. 273-275
    • Woodcock, J.1
  • 5
    • 33746551430 scopus 로고    scopus 로고
    • Available online
    • U.S. Food and Drug Administration. Critical Path Opportunities List, 2006. Available online: http://www.fda.gov/downloads/scienceresearch/specialtopics/criticalpathinitiative/criticalpathopportunitiesreports/UCM077258.pdf
    • (2006) Critical Path Opportunities List
  • 6
    • 33646245937 scopus 로고    scopus 로고
    • Executive summary of the PhRMA working group on adaptive designs in clinical drug development
    • Gallo P, Chuang S, Dragalin V, et al. Executive summary of the PhRMA working group on adaptive designs in clinical drug development. J Biopharm Stat 2006;16:275-83.
    • (2006) J Biopharm Stat , vol.16 , pp. 275-283
    • Gallo, P.1    Chuang, S.2    Dragalin, V.3
  • 7
    • 33644861229 scopus 로고    scopus 로고
    • Bayesian clinical trials
    • Berry DA. Bayesian clinical trials. Nat Rev Drug Discov 2006;5:27-36.
    • (2006) Nat Rev Drug Discov , vol.5 , pp. 27-36
    • Berry, D.A.1
  • 9
    • 84867439711 scopus 로고    scopus 로고
    • Bayesian clinical trials in action
    • Lee JJ, Chu CT. Bayesian clinical trials in action. Stat Med 2012;31:2955-72.
    • (2012) Stat Med , vol.31 , pp. 2955-2972
    • Lee, J.J.1    Chu, C.T.2
  • 11
    • 84859438491 scopus 로고    scopus 로고
    • Adaptive clinical trials in oncology
    • Berry DA. Adaptive clinical trials in oncology. Nat Rev Clin Oncol 2011;9:199-207.
    • (2011) Nat Rev Clin Oncol , vol.9 , pp. 199-207
    • Berry, D.A.1
  • 13
    • 77954875817 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services, Food and Drug Administration (CDER/CBER). Available online
    • FDA Guidance for industry: Adaptive design clinical trials for drugs and biologics. U.S. Department of Health and Human Services, Food and Drug Administration (CDER/CBER). Available online: http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf
    • FDA Guidance for industry: Adaptive design clinical trials for drugs and biologics
  • 14
    • 0024452804 scopus 로고
    • Design and analysis of Phase I clinical trials
    • Storer BE. Design and analysis of Phase I clinical trials. Biometrics 1989;45:925-37.
    • (1989) Biometrics , vol.45 , pp. 925-937
    • Storer, B.E.1
  • 16
    • 0025148278 scopus 로고
    • Continual reassessment method: A practical design for phase I clinical trials in cancer
    • O'Quigley J, Pepe M, Fisher LD. Continual reassessment method: A practical design for phase I clinical trials in cancer. Biometrics 1990;46:33-48.
    • (1990) Biometrics , vol.46 , pp. 33-48
    • O'Quigley, J.1    Pepe, M.2    Fisher, L.D.3
  • 17
    • 0028060511 scopus 로고
    • Practical modification of the continual reassessment methods for phase I clinical trials
    • Faries D. Practical modification of the continual reassessment methods for phase I clinical trials. J Biopharm Stat 1994;4:147-64.
    • (1994) J Biopharm Stat , vol.4 , pp. 147-164
    • Faries, D.1
  • 18
    • 0029027770 scopus 로고
    • Some practical improvements in the continual reassessment methods to phase I studies
    • Goodman SN, Zahurak ML, Piantadosi S. Some practical improvements in the continual reassessment methods to 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
  • 19
    • 70349776681 scopus 로고    scopus 로고
    • Bayesian model averaging continual reassessment method in phase I clinical trials
    • Yin G, and 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
  • 20
    • 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
  • 21
    • 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;56:1177-82.
    • (2000) Biometrics , vol.56 , pp. 1177-1182
    • Cheung, Y.K.1    Chappell, R.2
  • 22
    • 80054707561 scopus 로고    scopus 로고
    • Robust EM continual reassessment method in oncology dose finding
    • Yuan Y, Yin G. Robust EM continual reassessment method in oncology dose finding. J Am Stat Assoc 2011;106:818-31.
    • (2011) J Am Stat Assoc , vol.106 , pp. 818-831
    • Yuan, Y.1    Yin, G.2
  • 23
    • 84891532608 scopus 로고    scopus 로고
    • Bayesian data augmentation dose finding with continual reassessment method and delayed toxicity
    • Liu S, Yin G, Yuan Y. Bayesian data augmentation dose finding with continual reassessment method and delayed toxicity. Ann Appl Stat 2013;7:1837-2457.
    • (2013) Ann Appl Stat , vol.7 , pp. 1837-2457
    • Liu, S.1    Yin, G.2    Yuan, Y.3
  • 24
    • 4444272419 scopus 로고    scopus 로고
    • Dose-finding based on efficacy-toxicity trade-off
    • Thall PF, Cook J. Dose-finding based on efficacy-toxicity trade-off. Biometrics 2004;60:684-93.
    • (2004) Biometrics , vol.60 , pp. 684-693
    • Thall, P.F.1    Cook, J.2
  • 26
    • 84901271617 scopus 로고    scopus 로고
    • Adaptive designs for identifying optimal biological dose for molecularly targeted agents
    • Zang Y, Lee JJ, Yuan Y. Adaptive designs for identifying optimal biological dose for molecularly targeted agents. Clin Trials 2014;11:319-27.
    • (2014) Clin Trials , vol.11 , pp. 319-327
    • Zang, Y.1    Lee, J.J.2    Yuan, Y.3
  • 27
    • 33745956991 scopus 로고    scopus 로고
    • An adaptive dose-finding design incorporating both toxicity and efficacy
    • Zhang W, Sargent DJ, Mandrekar SJ. An adaptive dose-finding design incorporating both toxicity and efficacy. Stat Med 2006;25:2365-83.
    • (2006) Stat Med , vol.25 , pp. 2365-2383
    • Zhang, W.1    Sargent, D.J.2    Mandrekar, S.J.3
  • 28
    • 39849090451 scopus 로고    scopus 로고
    • Two-stage designs for dose-finding trials with a biologic endpoint using stepwise tests
    • Polley MY, Cheung YK. Two-stage designs for dose-finding trials with a biologic endpoint using stepwise tests. Biometrics 2008;64:232-41.
    • (2008) Biometrics , vol.64 , pp. 232-241
    • Polley, M.Y.1    Cheung, Y.K.2
  • 29
    • 0041833622 scopus 로고    scopus 로고
    • Dose-finding with two agents in phase I oncology trials
    • Thall PF, Millikan R, Muller P, et al. Dose-finding with two agents in phase I oncology trials. Biometrics 2003;59:487-96.
    • (2003) Biometrics , vol.59 , pp. 487-496
    • Thall, P.F.1    Millikan, R.2    Muller, P.3
  • 30
    • 63849316345 scopus 로고    scopus 로고
    • Bayesian dose-finding in oncology for drug combination by coupla regression
    • Yin G, Yuan Y. Bayesian dose-finding in oncology for drug combination by coupla regression. Journal of the Royal Statistical Society, Series C 2009;58:211-24.
    • (2009) Journal of the Royal Statistical Society, Series C , vol.58 , pp. 211-224
    • Yin, G.1    Yuan, Y.2
  • 31
    • 58749104211 scopus 로고    scopus 로고
    • Sequential continual reassessment method for two-dimensional dose findings
    • Yuan Y, Yin G. Sequential continual reassessment method for two-dimensional dose findings. Stat Med 2008;27:5664-78.
    • (2008) Stat Med , vol.27 , pp. 5664-5678
    • Yuan, Y.1    Yin, G.2
  • 32
    • 70349251729 scopus 로고    scopus 로고
    • A latent contingency table approach to dose-finding for combinations of two agents
    • Yin G, Yuan Y. A latent contingency table approach to dose-finding for combinations of two agents. Biometrics 2009;65:866-75.
    • (2009) Biometrics , vol.65 , pp. 866-875
    • Yin, G.1    Yuan, Y.2
  • 33
    • 34248324496 scopus 로고    scopus 로고
    • An adaptive phase I design for identifying a biologically optimal dose for dual agent drug combinations
    • Mandrekar SJ, Cui Y, Sargent DJ. An adaptive phase I design for identifying a biologically optimal dose for dual agent drug combinations. Stat Med 2007;26:2317-30.
    • (2007) Stat Med , vol.26 , pp. 2317-2330
    • Mandrekar, S.J.1    Cui, Y.2    Sargent, D.J.3
  • 34
    • 84922239156 scopus 로고    scopus 로고
    • The current design of oncology phase I clinical trials: progressing from algorithms to statistical models
    • Braun TM. The current design of oncology phase I clinical trials: progressing from algorithms to statistical models. Chin Clin Oncol 2014;3:2.
    • (2014) Chin Clin Oncol , vol.3 , pp. 2
    • Braun, T.M.1
  • 35
    • 50549174560 scopus 로고
    • The determination of the number of patients required in a follow-up trial of a new chemotherapeutic agent
    • Gehan EA. The determination of the number of patients required in a follow-up trial of a new chemotherapeutic agent. J Chronic Dis 1961;13:346-53.
    • (1961) J Chronic Dis , vol.13 , pp. 346-353
    • Gehan, E.A.1
  • 36
    • 0024536437 scopus 로고
    • Optimal two-stage designs for phase II clinical trials
    • Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989;10:1-10.
    • (1989) Control Clin Trials , vol.10 , pp. 1-10
    • Simon, R.1
  • 37
    • 0017744944 scopus 로고
    • Group sequential method in the design and analysis of clinical trials
    • Pocock SJ. Group sequential method in the design and analysis of clinical trials. Biometrika 1977;64:191-9.
    • (1977) Biometrika , vol.64 , pp. 191-199
    • Pocock, S.J.1
  • 38
    • 0018687930 scopus 로고
    • A multiple testing procedure for clinical trials
    • O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979;35:549-56.
    • (1979) Biometrics , vol.35 , pp. 549-556
    • O'Brien, P.C.1    Fleming, T.R.2
  • 39
    • 0023217456 scopus 로고
    • Approximately optimal one-parameter boundaries for group sequential trials
    • Wang SK, Tsiatis AA. Approximately optimal one-parameter boundaries for group sequential trials. Biometrics 1987;43:193-9.
    • (1987) Biometrics , vol.43 , pp. 193-199
    • Wang, S.K.1    Tsiatis, A.A.2
  • 40
    • 0027934302 scopus 로고
    • Interim analyses: the alpha spending function approach
    • DeMets DL, Lan KK. Interim analyses: the alpha spending function approach. Stat Med 1994;13:1341-52.
    • (1994) Stat Med , vol.13 , pp. 1341-1352
    • DeMets, D.L.1    Lan, K.K.2
  • 42
    • 0029589385 scopus 로고
    • Designed extension of studies based on conditional power
    • Proschan MA, Hunsberger SA. Designed extension of studies based on conditional power. Biometrics 1995;51:1315-24.
    • (1995) Biometrics , vol.51 , pp. 1315-1324
    • Proschan, M.A.1    Hunsberger, S.A.2
  • 43
    • 0032904107 scopus 로고    scopus 로고
    • Statistical inference for self-designing clinical trials with a one-sided hypothesis
    • Shen Y, Fisher L. Statistical inference for self-designing clinical trials with a one-sided hypothesis. Biometrics 1999;55:190-7.
    • (1999) Biometrics , vol.55 , pp. 190-197
    • Shen, Y.1    Fisher, L.2
  • 44
    • 1842826262 scopus 로고    scopus 로고
    • On the inefficiency of the adaptive design for monitoring clinical trials
    • Tsiatis AA, Mehta C. On the inefficiency of the adaptive design for monitoring clinical trials. Biometrika 2003;90:367-78.
    • (2003) Biometrika , vol.90 , pp. 367-378
    • Tsiatis, A.A.1    Mehta, C.2
  • 45
    • 0028279806 scopus 로고
    • Practical Bayesian guidelines for phase IIB clinical trials
    • Thall PF, Simon R. Practical Bayesian guidelines for phase IIB clinical trials. Biometrics 1994;50:337-49.
    • (1994) Biometrics , vol.50 , pp. 337-349
    • Thall, P.F.1    Simon, R.2
  • 46
    • 0028900407 scopus 로고
    • Bayesian sequential monitoring designs for single-arm clinical trials with multiple outcomes
    • Thall PF, Simon R, Estey EH. Bayesian sequential monitoring designs for single-arm clinical trials with multiple outcomes. Stat Med 1995;14:357-79.
    • (1995) Stat Med , vol.14 , pp. 357-379
    • Thall, P.F.1    Simon, R.2    Estey, E.H.3
  • 47
    • 30444432951 scopus 로고    scopus 로고
    • Monitoring event times in early phase clinical trials: some practical issues
    • Thall PF, Wooten L, Tannir N. Monitoring event times in early phase clinical trials: some practical issues. Clin Trials 2005;2:467-78.
    • (2005) Clin Trials , vol.2 , pp. 467-478
    • Thall, P.F.1    Wooten, L.2    Tannir, N.3
  • 48
    • 43649085358 scopus 로고    scopus 로고
    • A predictive probability design for phase II cancer clinical trials
    • Lee JJ, Liu DD. A predictive probability design for phase II cancer clinical trials. Clin Trials 2008;5:93-106.
    • (2008) Clin Trials , vol.5 , pp. 93-106
    • Lee, J.J.1    Liu, D.D.2
  • 49
    • 0016799829 scopus 로고
    • Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trials
    • Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trials. Biometrics 1975;31:103-15.
    • (1975) Biometrics , vol.31 , pp. 103-115
    • Pocock, S.J.1    Simon, R.2
  • 50
    • 0015627670 scopus 로고
    • International Symposium on Hodgkin's Diseas. Session 6. Survival data and prognosis. Invited discussion: Forcing a sequential experiment to be balanced
    • Efron B. International Symposium on Hodgkin's Diseas. Session 6. Survival data and prognosis. Invited discussion: Forcing a sequential experiment to be balanced. Natl Cancer Inst Monogr 1973;36:571-2.
    • (1973) Natl Cancer Inst Monogr , vol.36 , pp. 571-572
    • Efron, B.1
  • 51
    • 34247981226 scopus 로고
    • Play the winner rule and the controlled clinical trial
    • Zelen M. Play the winner rule and the controlled clinical trial. J Am Stat Assoc 1969;64:131-46.
    • (1969) J Am Stat Assoc , vol.64 , pp. 131-146
    • Zelen, M.1
  • 52
    • 84950622103 scopus 로고
    • The randomized play-the-winner rule in medical trials
    • Wei LJ, Durham S. The randomized play-the-winner rule in medical trials. J Am Stat Assoc 1978;73:840-3.
    • (1978) J Am Stat Assoc , vol.73 , pp. 840-843
    • Wei, L.J.1    Durham, S.2
  • 53
    • 0034862727 scopus 로고    scopus 로고
    • Optimal adaptive designs for binary response trials
    • Rosenberger WF, Stallard N, Ivanova A, et al. Optimal adaptive designs for binary response trials. Biometrics 2001;57:909-13.
    • (2001) Biometrics , vol.57 , pp. 909-913
    • Rosenberger, W.F.1    Stallard, N.2    Ivanova, A.3
  • 54
    • 38149145171 scopus 로고
    • The doubly adaptive biased coin design for sequential clinical trials
    • Eisele JR. The doubly adaptive biased coin design for sequential clinical trials. Journal of Statistical Planning and Inference 1994;38:249-61.
    • (1994) Journal of Statistical Planning and Inference , vol.38 , pp. 249-261
    • Eisele, J.R.1
  • 55
    • 26844516148 scopus 로고    scopus 로고
    • Asymptotic properties of doubly adaptive biased coin designs for multitreatment clinical trials
    • Hf F, Zhang LX. Asymptotic properties of doubly adaptive biased coin designs for multitreatment clinical trials. Ann Statist 2004;32:268-301.
    • (2004) Ann Statist , vol.32 , pp. 268-301
    • Hf, F.1    Zhang, L.X.2
  • 56
    • 33847666453 scopus 로고    scopus 로고
    • Practical Bayesian adaptive randomisation in clinical trials
    • Thall PF, Wathen KJ. Practical Bayesian adaptive randomisation in clinical trials. Eur J Cancer 2007;43:859-66.
    • (2007) Eur J Cancer , vol.43 , pp. 859-866
    • Thall, P.F.1    Wathen, K.J.2
  • 57
    • 78649956851 scopus 로고    scopus 로고
    • Bayesian adaptive randomization designs for targeted agent development
    • Lee JJ, Gu XM, Liu SY. Bayesian adaptive randomization designs for targeted agent development. Clin Trials 2010;7:584-96.
    • (2010) Clin Trials , vol.7 , pp. 584-596
    • Lee, J.J.1    Gu, X.M.2    Liu, S.Y.3
  • 58
    • 84858160948 scopus 로고    scopus 로고
    • Phase II trial design with Bayesian adaptive randomization and predictive probability
    • Yin G, Chen N, Lee JJ. Phase II trial design with Bayesian adaptive randomization and predictive probability. J R Stat Soc Ser C Appl Stat 2012;61.
    • (2012) J R Stat Soc Ser C Appl Stat , pp. 61
    • Yin, G.1    Chen, N.2    Lee, J.J.3
  • 59
    • 78650339993 scopus 로고    scopus 로고
    • Outcome--adaptive randomization: is it useful?
    • Korn EL, Freidlin B. Outcome--adaptive randomization: is it useful? J Clin Oncol 2011;29:771-6.
    • (2011) J Clin Oncol , vol.29 , pp. 771-776
    • Korn, E.L.1    Freidlin, B.2
  • 60
    • 84865740846 scopus 로고    scopus 로고
    • Worth adapting? Revisiting the usefulness of outcome-adaptive randomization
    • Lee JJ, Chen N, Yin G. Worth adapting? Revisiting the usefulness of outcome-adaptive randomization. Clin Cancer Res 2012;18:4498-507.
    • (2012) Clin Cancer Res , vol.18 , pp. 4498-4507
    • Lee, J.J.1    Chen, N.2    Yin, G.3
  • 61
    • 0012838924 scopus 로고    scopus 로고
    • Adaptive Bayesian designs for dose-ranging drug trials
    • Gatsonis C, Kass RE, Carlin B, et al. eds, New York: Springer-Verlag
    • Berry DA, Muller P, Grieve AP, et al. Adaptive Bayesian designs for dose-ranging drug trials, In: Gatsonis C, Kass RE, Carlin B, et al. eds. Case Studies in Bayesian Statistics, Volume V. New York: Springer-Verlag, 2001.
    • (2001) Case Studies in Bayesian Statistics , vol.5
    • Berry, D.A.1    Muller, P.2    Grieve, A.P.3
  • 62
    • 84899904132 scopus 로고    scopus 로고
    • A comparison of Bayesian adaptive randomization and multi-stage designs for multi-arm clinical trials
    • Wason JM, Trippa L. A comparison of Bayesian adaptive randomization and multi-stage designs for multi-arm clinical trials. Statistics in Medicine 2014;33:2206-21.
    • (2014) Statistics in Medicine , vol.33 , pp. 2206-2221
    • Wason, J.M.1    Trippa, L.2
  • 63
    • 0027949027 scopus 로고
    • Simulation as a design tool for phase I/II clinical trials: an example from bone marrow transplantation
    • Gooley TA, Martin PJ, Fisher LD, et al. Simulation as a design tool for phase I/II clinical trials: an example from bone marrow transplantation. Control Clin Trials 1994;15:450-62.
    • (1994) Control Clin Trials , vol.15 , pp. 450-462
    • Gooley, T.A.1    Martin, P.J.2    Fisher, L.D.3
  • 64
    • 0031953966 scopus 로고    scopus 로고
    • A strategy for dose-finding and safety monitoring based on efficacy and adverse outcomes in phase I/II clinical trials
    • Thall PF, Russell KE. A strategy for dose-finding and safety monitoring based on efficacy and adverse outcomes in phase I/II clinical trials. Biometrics 1998;54:251-64.
    • (1998) Biometrics , vol.54 , pp. 251-264
    • Thall, P.F.1    Russell, K.E.2
  • 65
  • 66
    • 33748795036 scopus 로고    scopus 로고
    • Bayesian dose-finding in phase I/II trials using toxicity and efficacy odds ratio
    • Yin G, Li Y, Ji Y. Bayesian dose-finding in phase I/II trials using toxicity and efficacy odds ratio. Biometrics 2006;62:777-84.
    • (2006) Biometrics , vol.62 , pp. 777-784
    • Yin, G.1    Li, Y.2    Ji, Y.3
  • 67
    • 34547659861 scopus 로고    scopus 로고
    • A parallel phase I/II clinical trial design for combination therapies
    • Huang X, Biswas S, Oki Y, et al. A parallel phase I/II clinical trial design for combination therapies. Biometrics 2007;63:429-36.
    • (2007) Biometrics , vol.63 , pp. 429-436
    • Huang, X.1    Biswas, S.2    Oki, Y.3
  • 68
    • 84873378000 scopus 로고    scopus 로고
    • Bayesian phase I/II drug-combination trial design in oncology
    • Yuan Y, Yin G. Bayesian phase I/II drug-combination trial design in oncology. Ann Appl Stat 2011;5:924-42.
    • (2011) Ann Appl Stat , vol.5 , pp. 924-942
    • Yuan, Y.1    Yin, G.2
  • 69
    • 79951823629 scopus 로고    scopus 로고
    • Seamless phase I-II trial design for assessing toxicity and efficacy for targeted agents
    • Hoering A, LeBlanc M, Crowley J. Seamless phase I-II trial design for assessing toxicity and efficacy for targeted agents. Clin Cancer Res 2011;17:640-6.
    • (2011) Clin Cancer Res , vol.17 , pp. 640-646
    • Hoering, A.1    LeBlanc, M.2    Crowley, J.3
  • 70
    • 0036968867 scopus 로고    scopus 로고
    • Seamlessly expanding a randomized phase II trial to phase III
    • Inoue LYT, Thall P, Berry DA. Seamlessly expanding a randomized phase II trial to phase III. Biometrics 2002;58:823-31.
    • (2002) Biometrics , vol.58 , pp. 823-831
    • Inoue, L.Y.T.1    Thall, P.2    Berry, D.A.3
  • 71
    • 69949103780 scopus 로고    scopus 로고
    • Using short-term response information to facilitate adaptive randomization for survival clinical trials
    • Huang X, Ning J, Li Y, et al. Using short-term response information to facilitate adaptive randomization for survival clinical trials. Stat Med 2009;28:1680-9.
    • (2009) Stat Med , vol.28 , pp. 1680-1689
    • Huang, X.1    Ning, J.2    Li, Y.3
  • 72
    • 77950912779 scopus 로고    scopus 로고
    • A confirmatory seamless phase II/III clinical trial design incorporating short-term endpoint information
    • Stallard N. A confirmatory seamless phase II/III clinical trial design incorporating short-term endpoint information. Stat Med 2010;29:959-71.
    • (2010) Stat Med , vol.29 , pp. 959-971
    • Stallard, N.1
  • 73
    • 65549144401 scopus 로고    scopus 로고
    • Dose selection in seamless phase II/III clinical trials based on efficacy and safety
    • Kimani PK, Stallard N, Hutton JL. Dose selection in seamless phase II/III clinical trials based on efficacy and safety. Stat Med 2009;28:917-36.
    • (2009) Stat Med , vol.28 , pp. 917-936
    • Kimani, P.K.1    Stallard, N.2    Hutton, J.L.3
  • 74
    • 70449623272 scopus 로고    scopus 로고
    • A seamless phase II/III design with sample-size reestimation
    • Bischoff W, Miller F. A seamless phase II/III design with sample-size reestimation. J Biopharm Stat 2009;19:595-609.
    • (2009) J Biopharm Stat , vol.19 , pp. 595-609
    • Bischoff, W.1    Miller, F.2
  • 75
    • 84964240627 scopus 로고    scopus 로고
    • Some recommendations for multi-arm multi-stage trials
    • Epub ahead of print
    • Wason J, Magirr D, Law M, et al. Some recommendations for multi-arm multi-stage trials. Stat Methods Med Res 2013. [Epub ahead of print].
    • (2013) Stat Methods Med Res
    • Wason, J.1    Magirr, D.2    Law, M.3
  • 76
    • 67650216185 scopus 로고    scopus 로고
    • Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial
    • Sydes MR, Parmar MK, James ND, et al. Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial. Trials 2009;10:39.
    • (2009) Trials , vol.10 , pp. 39
    • Sydes, M.R.1    Parmar, M.K.2    James, N.D.3
  • 77
    • 9244222261 scopus 로고    scopus 로고
    • Targeted cancer therapy
    • Sawyers C. Targeted cancer therapy. Nature 2004;432:294-7.
    • (2004) Nature , vol.432 , pp. 294-297
    • Sawyers, C.1
  • 78
    • 15544389968 scopus 로고    scopus 로고
    • What is targeted therapy?
    • Sledge GW. What is targeted therapy? J Clin Oncol 2005;23:1614-15.
    • (2005) J Clin Oncol , vol.23 , pp. 1614-1615
    • Sledge, G.W.1
  • 79
    • 69849108427 scopus 로고    scopus 로고
    • Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges
    • Mandrekar SJ, Sargent DJ. Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges. J Clin Oncol 2009;27:4027-34.
    • (2009) J Clin Oncol , vol.27 , pp. 4027-4034
    • Mandrekar, S.J.1    Sargent, D.J.2
  • 80
    • 76349100026 scopus 로고    scopus 로고
    • Randomized clinical trials with biomarkers: design issues
    • Freidlin B, McShane LM, Korn EL. Randomized clinical trials with biomarkers: design issues. J Natl Cancer Inst 2010;102:152-60.
    • (2010) J Natl Cancer Inst , vol.102 , pp. 152-160
    • Freidlin, B.1    McShane, L.M.2    Korn, E.L.3
  • 81
    • 84886941454 scopus 로고    scopus 로고
    • Statistical issues in the validation of prognostic, predictive, and surrogate biomarkers
    • Sargent DJ, Mandrekar SJ. Statistical issues in the validation of prognostic, predictive, and surrogate biomarkers. Clin Trials 2013;10:647-52.
    • (2013) Clin Trials , vol.10 , pp. 647-652
    • Sargent, D.J.1    Mandrekar, S.J.2
  • 82
    • 84888132659 scopus 로고    scopus 로고
    • A review of phase II trial designs for initial marker validation
    • Mandrekar SJ, Sargent DJ. A review of phase II trial designs for initial marker validation. Contemp Clin Trials 2013;36:597-604.
    • (2013) Contemp Clin Trials , vol.36 , pp. 597-604
    • Mandrekar, S.J.1    Sargent, D.J.2
  • 83
    • 0036269892 scopus 로고    scopus 로고
    • Issues in clinical trial design for tumor marker studies
    • Sargent D, Allegra C. Issues in clinical trial design for tumor marker studies. Semin Oncol 2002;29:222-30.
    • (2002) Semin Oncol , vol.29 , pp. 222-230
    • Sargent, D.1    Allegra, C.2
  • 84
    • 15744374441 scopus 로고    scopus 로고
    • Clinical trial designs for predictive marker validation in cancer treatment trials
    • Sargent DJ, Conley BA, Allegra C, et al. Clinical trial designs for predictive marker validation in cancer treatment trials. J Clin Oncol 2005;23:2020-27.
    • (2005) J Clin Oncol , vol.23 , pp. 2020-2027
    • Sargent, D.J.1    Conley, B.A.2    Allegra, C.3
  • 85
    • 84858166365 scopus 로고    scopus 로고
    • Molecular pathways: microsatellite instability in colorectal cancer: prognostic, predictive, and therapeutic implications
    • Sinicrope FA, Sargent DJ. Molecular pathways: microsatellite instability in colorectal cancer: prognostic, predictive, and therapeutic implications. Clin Cancer Res 2012;18:1506-12.
    • (2012) Clin Cancer Res , vol.18 , pp. 1506-1512
    • Sinicrope, F.A.1    Sargent, D.J.2
  • 86
    • 6044278144 scopus 로고    scopus 로고
    • Perspective evaluating the efficiency of targeted designs for randomized clinical trials
    • Simon R, Maitournam A. Perspective evaluating the efficiency of targeted designs for randomized clinical trials. Clin Cancer Res 2004;10:6759-63.
    • (2004) Clin Cancer Res , vol.10 , pp. 6759-6763
    • Simon, R.1    Maitournam, A.2
  • 87
    • 13644270099 scopus 로고    scopus 로고
    • On the efficiency of targeted clinical trials
    • Maitournam A, Simon R. On the efficiency of targeted clinical trials. Stat Med 2005;24:329-39.
    • (2005) Stat Med , vol.24 , pp. 329-339
    • Maitournam, A.1    Simon, R.2
  • 88
    • 24644438754 scopus 로고    scopus 로고
    • Evaluation of randomized discontinuation design
    • Freidlin B, Simon R. Evaluation of randomized discontinuation design. J Clin Oncol 2005;23:5094-98.
    • (2005) J Clin Oncol , vol.23 , pp. 5094-5098
    • Freidlin, B.1    Simon, R.2
  • 89
    • 58149151278 scopus 로고    scopus 로고
    • The use of genomics in clinical trial design
    • Simon R. The use of genomics in clinical trial design. Clin Cancer Res 2008;14:5984-93.
    • (2008) Clin Cancer Res , vol.14 , pp. 5984-5993
    • Simon, R.1
  • 90
    • 84880991913 scopus 로고    scopus 로고
    • "Basket studies" will hold intricate data for cancer drug approvals
    • Willyard C. "Basket studies" will hold intricate data for cancer drug approvals. Nat Med 2013;19:655.
    • (2013) Nat Med , vol.19 , pp. 655
    • Willyard, C.1
  • 91
    • 79952590347 scopus 로고    scopus 로고
    • The n-of-1 clinical trial: the ultimate strategy for individualizing medicine?
    • Lillie EO, Patay B, Diamant J, et al. The n-of-1 clinical trial: the ultimate strategy for individualizing medicine? Per Med 2011;8:161-73.
    • (2011) Per Med , vol.8 , pp. 161-173
    • Lillie, E.O.1    Patay, B.2    Diamant, J.3
  • 92
    • 84960462590 scopus 로고    scopus 로고
    • Available online
    • Friends of Cancer Research (2013) Design of a lung cancer master protocol. Available online: http://www.focr.org/events/design-lung-cancer-master-protocol
    • (2013) Design of a lung cancer master protocol
  • 93
    • 84960450147 scopus 로고    scopus 로고
    • Biomarker based clinical trial design
    • Simon R. Biomarker based clinical trial design. Chin Clin Oncol 2014;3:39.
    • (2014) Chin Clin Oncol , vol.3 , pp. 39
    • Simon, R.1
  • 94
    • 52649154223 scopus 로고    scopus 로고
    • Bayesian adaptive design for targeted therapy development in lung cancer-a step toward personalized medicine
    • Zhou X, Liu S, Kim ES, et al. Bayesian adaptive design for targeted therapy development in lung cancer-a step toward personalized medicine. Clin Trials 2008;5:181-93.
    • (2008) Clin Trials , vol.5 , pp. 181-193
    • Zhou, X.1    Liu, S.2    Kim, E.S.3
  • 95
    • 79957857433 scopus 로고    scopus 로고
    • The BATTLE Trial: Personalizing therapy for lung cancer
    • Kim ES, Herbst RS, Wistuba II, et al. The BATTLE Trial: Personalizing therapy for lung cancer. Cancer Discov 2011;1:44-53.
    • (2011) Cancer Discov , vol.1 , pp. 44-53
    • Kim, E.S.1    Herbst, R.S.2    Wistuba, I.I.3
  • 96
    • 84856523576 scopus 로고    scopus 로고
    • Reports from the 2010 Clinical and Translational Cancer Research Think Tank meeting: design strategies for personalized therapy trials
    • Berry DA, Herbst RS, Rubin EH. Reports from the 2010 Clinical and Translational Cancer Research Think Tank meeting: design strategies for personalized therapy trials. Clin Cancer Res 2012;18:638-44.
    • (2012) Clin Cancer Res , vol.18 , pp. 638-644
    • Berry, D.A.1    Herbst, R.S.2    Rubin, E.H.3
  • 97
    • 67650652432 scopus 로고    scopus 로고
    • I-SPY 2: An adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy
    • Barker AD, Sigman CC, Kelloff GJ, et al. I-SPY 2: An adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clin Pharmacol Ther 2009;86:97-100.
    • (2009) Clin Pharmacol Ther , vol.86 , pp. 97-100
    • Barker, A.D.1    Sigman, C.C.2    Kelloff, G.J.3
  • 98
    • 84868617384 scopus 로고    scopus 로고
    • I-SPY 2 breast cancer clinical trial launches nationwide
    • Carrie P. I-SPY 2 breast cancer clinical trial launches nationwide. Cancer 2010;116:3308.
    • (2010) Cancer , vol.116 , pp. 3308
    • Carrie, P.1
  • 99
    • 84960377580 scopus 로고    scopus 로고
    • Available online
    • Quantum Leap (2013) I-SPY 2 Trial graduates 2 new drugs. Available online: http://www.quantumleaphealth.org/spy-2-trial-graduates-2-new-drugs-press-release/
    • (2013) I-SPY 2 Trial graduates 2 new drugs
  • 100
    • 84960350186 scopus 로고    scopus 로고
    • Software for design of clinical trials
    • Crowley J, Hoering A. eds, 3rd ed. Boca Raton, FL: Chapman and Hall/CRC Press
    • Lee JJ, Chen N. Software for design of clinical trials. In: Crowley J, Hoering A. eds. Handbook of Statistics in Clinical Oncology, 3rd ed. Boca Raton, FL: Chapman and Hall/CRC Press, 2011.
    • (2011) Handbook of Statistics in Clinical Oncology
    • Lee, J.J.1    Chen, N.2
  • 101
    • 44949171503 scopus 로고    scopus 로고
    • Adaptive design methods in clinical trials -- a review
    • Chow SC, 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
  • 102
    • 70350139975 scopus 로고    scopus 로고
    • Good practices for adaptive clinical trials in pharmaceutical product development
    • Gaydos B, Anderson KM, Berry D, et al. Good practices for adaptive clinical trials in pharmaceutical product development. Drug Inf J 2009;43:539-56.
    • (2009) Drug Inf J , vol.43 , pp. 539-556
    • Gaydos, B.1    Anderson, K.M.2    Berry, D.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.