메뉴 건너뛰기




Volumn 19, Issue 17, 2013, Pages 4578-4588

Trial designs for personalizing cancer care: A systematic review and classification

Author keywords

[No Author keywords available]

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; ERLOTINIB; PLACEBO; TAMOXIFEN; TRASTUZUMAB; TUMOR MARKER;

EID: 84883483981     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-12-3722     Document Type: Review
Times cited : (47)

References (91)
  • 1
    • 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
  • 3
    • 67651030311 scopus 로고    scopus 로고
    • Clinical trial designs for predictive biomarker validation: One size does not fit all
    • Mandrekar SJ, Sargent DJ. Clinical trial designs for predictive biomarker validation: one size does not fit all. J Biopharm Stat 2009;19:530-42.
    • (2009) J Biopharm Stat , vol.19 , pp. 530-542
    • Mandrekar, S.J.1    Sargent, D.J.2
  • 4
    • 77949673913 scopus 로고    scopus 로고
    • The design of phase II clinical trials testing cancer therapeutics: Consensus recommendations from the clinical trial design task force of the national cancer institute investigational drug steering committee
    • Seymour L, Ivy SP, Sargent D, Spriggs D, Baker L, Rubinstein L, et al. The design of phase II clinical trials testing cancer therapeutics: consensus recommendations from the clinical trial design task force of the national cancer institute investigational drug steering committee. Clin Cancer Res 2010;16:1764-9.
    • (2010) Clin Cancer Res , vol.16 , pp. 1764-1769
    • Seymour, L.1    Ivy, S.P.2    Sargent, D.3    Spriggs, D.4    Baker, L.5    Rubinstein, L.6
  • 5
    • 77949477559 scopus 로고    scopus 로고
    • Phase II clinical trials in oncology: Are we hitting the target?
    • Ang MK, Tan SB, Lim WT. Phase II clinical trials in oncology: are we hitting the target? Expert Rev Anticancer Ther 2010;10:427-38.
    • (2010) Expert Rev Anticancer Ther , vol.10 , pp. 427-438
    • Ang, M.K.1    Tan, S.B.2    Lim, W.T.3
  • 6
    • 73949161270 scopus 로고    scopus 로고
    • Trial design for evaluation of novel targeted therapies
    • Farley J, Rose PG. Trial design for evaluation of novel targeted therapies. Gynecol Oncol 2010;116:173-6.
    • (2010) Gynecol Oncol , vol.116 , pp. 173-176
    • Farley, J.1    Rose, P.G.2
  • 7
    • 63449108223 scopus 로고    scopus 로고
    • Effective incorporation of biomarkers into phase II trials
    • McShane LM, Hunsberger S, Adjei AA. Effective incorporation of biomarkers into phase II trials. Clin Cancer Res 2009;15:1898-905.
    • (2009) Clin Cancer Res , vol.15 , pp. 1898-1905
    • McShane, L.M.1    Hunsberger, S.2    Adjei, A.A.3
  • 8
    • 10944260135 scopus 로고    scopus 로고
    • Clinical trial design for microarray predictive marker discovery and assessment
    • DOI 10.1093/annonc/mdh466
    • Pusztai L, Hess KR. Clinical trial design for microarray predictive marker discovery and assessment. Ann Oncol 2004;15:1731-7. (Pubitemid 40012239)
    • (2004) Annals of Oncology , vol.15 , Issue.12 , pp. 1731-1737
    • Pusztai, L.1    Hess, K.R.2
  • 11
    • 72449123164 scopus 로고    scopus 로고
    • Methodological aspects of lung cancer clinical trials in the era of targeted agents
    • Di MM, Gallo C, De ME, Morabito A, Piccirillo MC, Gridelli C, et al. Methodological aspects of lung cancer clinical trials in the era of targeted agents. Lung Cancer 2010;67:127-35.
    • (2010) Lung Cancer , vol.67 , pp. 127-135
    • Di, M.M.1    Gallo, C.2    De, M.E.3    Morabito, A.4    Piccirillo, M.C.5    Gridelli, C.6
  • 13
    • 51649085832 scopus 로고    scopus 로고
    • Randomized phase III clinical trial designs for targeted agents
    • Hoering A, Leblanc M, Crowley JJ. Randomized phase III clinical trial designs for targeted agents. Clin Cancer Res 2008;14:4358-67.
    • (2008) Clin Cancer Res , vol.14 , pp. 4358-4367
    • Hoering, A.1    Leblanc, M.2    Crowley, J.J.3
  • 14
    • 84872044846 scopus 로고    scopus 로고
    • Novel strategies to test biological hypotheses in early drug development for advanced prostate cancer
    • Ferraldeschi R, Attard G, de Bono JS. Novel strategies to test biological hypotheses in early drug development for advanced prostate cancer. Clin Chem 2013;59:75-84.
    • (2013) Clin Chem , vol.59 , pp. 75-84
    • Ferraldeschi, R.1    Attard, G.2    De Bono, J.S.3
  • 15
    • 84861814820 scopus 로고    scopus 로고
    • Clinical trial designs for testing biomarker-based personalized therapies
    • Lai TL, Lavori PW, Shih MC, Sikic BI. Clinical trial designs for testing biomarker-based personalized therapies. Clin Trials 2012;9:141-54.
    • (2012) Clin Trials , vol.9 , pp. 141-154
    • Lai, T.L.1    Lavori, P.W.2    Shih, M.C.3    Sikic, B.I.4
  • 16
    • 84865080246 scopus 로고    scopus 로고
    • A 2-stage phase II design with direct assignment option in stage II for initial marker validation
    • An MW, Mandrekar SJ, Sargent DJ. A 2-stage phase II design with direct assignment option in stage II for initial marker validation. Clin Cancer Res 2012;18:4225-33.
    • (2012) Clin Cancer Res , vol.18 , pp. 4225-4233
    • An, M.W.1    Mandrekar, S.J.2    Sargent, D.J.3
  • 18
    • 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
  • 19
    • 78349294600 scopus 로고    scopus 로고
    • Statistical design of personalized medicine interventions: The Clarification of Optimal Anticoagulation through Genetics (COAG) trial
    • French B, Joo J, Geller NL, Kimmel SE, Rosenberg Y, Anderson JL, et al. Statistical design of personalized medicine interventions: the Clarification of Optimal Anticoagulation through Genetics (COAG) trial. Trials 2010;11:108.
    • (2010) Trials , vol.11 , pp. 108
    • French, B.1    Joo, J.2    Geller, N.L.3    Kimmel, S.E.4    Rosenberg, Y.5    Anderson, J.L.6
  • 20
    • 13644270099 scopus 로고    scopus 로고
    • On the efficiency of targeted clinical trials
    • DOI 10.1002/sim.1975
    • Maitournam A, Simon R. On the efficiency of targeted clinical trials. Stat Med 2005;24:329-39. (Pubitemid 40227650)
    • (2005) Statistics in Medicine , vol.24 , Issue.3 , pp. 329-339
    • Maitournam, A.1    Simon, R.2
  • 21
    • 45949107161 scopus 로고    scopus 로고
    • Clinical trials of novel and targeted therapies: Endpoints, trial design, and analysis
    • DOI 10.1080/07357900801971057, PII 793254499
    • Suman VJ, Dueck A, Sargent DJ. Clinical trials of novel and targeted therapies: endpoints, trial design, and analysis. Cancer Invest 2008;26:439-44. (Pubitemid 351892581)
    • (2008) Cancer Investigation , vol.26 , Issue.5 , pp. 439-444
    • Suman, V.J.1    Dueck, A.2    Sargent, D.J.3
  • 22
    • 0034715985 scopus 로고    scopus 로고
    • Randomised comparisons of medical tests: Sometimes invalid, not always efficient
    • Bossuyt PM, Lijmer JG, Mol BW. Randomised comparisons of medical tests: sometimes invalid, not always efficient. Lancet 2000;356:1844-7.
    • (2000) Lancet , vol.356 , pp. 1844-1847
    • Bossuyt, P.M.1    Lijmer, J.G.2    Mol, B.W.3
  • 23
    • 80053484515 scopus 로고    scopus 로고
    • Integrating predictive biomarkers and classifiers into oncology clinical development programmes
    • Beckman RA, Clark J, Chen C. Integrating predictive biomarkers and classifiers into oncology clinical development programmes. Nat Rev Drug Discov 2011;10:735-48.
    • (2011) Nat Rev Drug Discov , vol.10 , pp. 735-748
    • Beckman, R.A.1    Clark, J.2    Chen, C.3
  • 24
    • 76449115854 scopus 로고    scopus 로고
    • Genomic markers for decision making: What is preventing us from using markers?
    • Coyle VM, Johnston PG. Genomic markers for decision making: what is preventing us from using markers? Nat Rev Clin Oncol 2010;7:90-7.
    • (2010) Nat Rev Clin Oncol , vol.7 , pp. 90-97
    • Coyle, V.M.1    Johnston, P.G.2
  • 25
    • 35348814333 scopus 로고    scopus 로고
    • Development and validation of biomarker classifiers for treatment selection
    • Simon R. Development and validation of biomarker classifiers for treatment selection. J Stat Plan Inference 2008;138:308-20.
    • (2008) J Stat Plan Inference , vol.138 , pp. 308-320
    • Simon, R.1
  • 26
    • 1542545085 scopus 로고    scopus 로고
    • Clinical trial methods to discover and validate predictive markers for treatment response in cancer
    • DOI 10.1016/S1387-2656(03)09005-7
    • Paik S. Clinical trial methods to discover and validate predictive markers for treatment response in cancer. Biotechnol Annu Rev 2003;9:259-67. (Pubitemid 41085858)
    • (2003) Biotechnology Annual Review , vol.9 , pp. 259-267
    • Paik, S.1
  • 27
    • 78649960550 scopus 로고    scopus 로고
    • Statistical considerations in evaluating pharmacogenomics-based clinical effect for confirmatory trials
    • Wang SJ, O'Neill RT, Hung HJ. Statistical considerations in evaluating pharmacogenomics-based clinical effect for confirmatory trials. Clin Trials 2010;7:525-36.
    • (2010) Clin Trials , vol.7 , pp. 525-536
    • Wang, S.J.1    O'Neill, R.T.2    Hung, H.J.3
  • 28
    • 78649956851 scopus 로고    scopus 로고
    • Bayesian adaptive randomization designs for targeted agent development
    • Lee JJ, Xuemin G, Suyu L. 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    Xuemin, G.2    Suyu, L.3
  • 29
    • 84867439073 scopus 로고    scopus 로고
    • Clinical trials for predictive medicine
    • Simon R. Clinical trials for predictive medicine. Stat Med 2012;31:3031-40.
    • (2012) Stat Med , vol.31 , pp. 3031-3040
    • Simon, R.1
  • 30
    • 84872370490 scopus 로고    scopus 로고
    • Incorporation of prognostic and predictive factors into glioma clinical trials
    • Johnson DR, Galanis E. Incorporation of prognostic and predictive factors into glioma clinical trials. Curr Oncol Rep 2013;15:56-63.
    • (2013) Curr Oncol Rep , vol.15 , pp. 56-63
    • Johnson, D.R.1    Galanis, E.2
  • 31
    • 35548980453 scopus 로고    scopus 로고
    • Towards validation of statistically reliable biomarkers
    • DOI 10.1016/S1359-6349(07)70028-9, PII S1359634907700289, ECCO 14 Educational Book
    • Buyse M. Towards validation of statistically reliable biomarkers. Eur J Cancer Suppl 2007;5:89-95. (Pubitemid 350017011)
    • (2007) European Journal of Cancer, Supplement , vol.5 , Issue.5 , pp. 89-95
    • Buyse, M.1
  • 32
    • 68349115159 scopus 로고    scopus 로고
    • Molecular biomarkers to individualise treatment: Assessing the evidence
    • Lee CK, Lord SJ, Coates AS, Simes RJ. Molecular biomarkers to individualise treatment: assessing the evidence. Med J Aust 2009;190:631-6.
    • (2009) Med J Aust , vol.190 , pp. 631-636
    • Lee, C.K.1    Lord, S.J.2    Coates, A.S.3    Simes, R.J.4
  • 33
    • 74049098972 scopus 로고    scopus 로고
    • Clinical trial designs for evaluating the medical utility of prognostic and predictive biomarkers in oncology
    • Simon R. Clinical trial designs for evaluating the medical utility of prognostic and predictive biomarkers in oncology. Per Med 2010;7:33-47.
    • (2010) Per Med , vol.7 , pp. 33-47
    • Simon, R.1
  • 34
    • 84874501540 scopus 로고    scopus 로고
    • Designs and challenges for personalized medicine studies in oncology: Focus on the SHIVA trial
    • Le TC, Kamal M, Tredan O, Delord JP, Campone M, Goncalves A, et al. Designs and challenges for personalized medicine studies in oncology: focus on the SHIVA trial. Target Oncol 2012;7:253-65.
    • (2012) Target Oncol , vol.7 , pp. 253-265
    • Le, T.C.1    Kamal, M.2    Tredan, O.3    Delord, J.P.4    Campone, M.5    Goncalves, A.6
  • 36
    • 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, Herbst RS, Lee JJ. 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    Herbst, R.S.4    Lee, J.J.5
  • 37
    • 77955599966 scopus 로고    scopus 로고
    • Biostatistic tools in pharmacogenomics - Advances, challenges, potential
    • Sato Y, Laird NM, Yoshida T. Biostatistic tools in pharmacogenomics - advances, challenges, potential. Curr Pharm Des 2010;16:2232-40.
    • (2010) Curr Pharm des , vol.16 , pp. 2232-2240
    • Sato, Y.1    Laird, N.M.2    Yoshida, T.3
  • 38
    • 84866791471 scopus 로고    scopus 로고
    • Biomarkers, subgroup evaluation, and clinical trial design
    • Baker SG, Kramer BS, Sargent DJ, Bonetti M. Biomarkers, subgroup evaluation, and clinical trial design. Discov Med 2012;13:187-92.
    • (2012) Discov Med , vol.13 , pp. 187-192
    • Baker, S.G.1    Kramer, B.S.2    Sargent, D.J.3    Bonetti, M.4
  • 39
    • 78649923786 scopus 로고    scopus 로고
    • Predictive biomarker validation in practice: Lessons from real trials
    • Mandrekar SJ, Sargent DJ. Predictive biomarker validation in practice: lessons from real trials. Clin Trials 2010;7:567-73.
    • (2010) Clin Trials , vol.7 , pp. 567-573
    • Mandrekar, S.J.1    Sargent, D.J.2
  • 40
    • 34447264769 scopus 로고    scopus 로고
    • Biomarker-adaptive threshold design: A procedure for evaluating treatment with possible biomarker-defined subset effect
    • DOI 10.1093/jnci/djm022, Pdf Contents
    • Jiang W, Freidlin B, Simon R. Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect. J Natl Cancer Inst 2007;99:1036-43. (Pubitemid 47232604)
    • (2007) Journal of the National Cancer Institute , vol.99 , Issue.13 , pp. 1036-1043
    • Jiang, W.1    Freidlin, B.2    Simon, R.3
  • 41
    • 27744537954 scopus 로고    scopus 로고
    • Adaptive signature design: An adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients
    • DOI 10.1158/1078-0432.CCR-05-0605
    • Freidlin B, Simon R. Adaptive signature design: an adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients. Clin Cancer Res 2005;11:7872-8. (Pubitemid 41611633)
    • (2005) Clinical Cancer Research , vol.11 , Issue.21 , pp. 7872-7878
    • Freidlin, B.1    Simon, R.2
  • 42
    • 74549207384 scopus 로고    scopus 로고
    • The cross-validated adaptive signature design
    • Freidlin B, Jiang W, Simon R. The cross-validated adaptive signature design. Clin Cancer Res 2010;16:691-8.
    • (2010) Clin Cancer Res , vol.16 , pp. 691-698
    • Freidlin, B.1    Jiang, W.2    Simon, R.3
  • 43
    • 77953541527 scopus 로고    scopus 로고
    • Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: A multicentre, randomised, placebo-controlled phase 3 study
    • Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczesna A, Juhasz E, et al. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol 2010;11:521-9.
    • (2010) Lancet Oncol , vol.11 , pp. 521-529
    • Cappuzzo, F.1    Ciuleanu, T.2    Stelmakh, L.3    Cicenas, S.4    Szczesna, A.5    Juhasz, E.6
  • 44
    • 78650334788 scopus 로고    scopus 로고
    • Biomarker-adaptive clinical trial designs
    • Freidlin B, Korn EL. Biomarker-adaptive clinical trial designs. Pharmacogenomics 2010;11:1679-82.
    • (2010) Pharmacogenomics , vol.11 , pp. 1679-1682
    • Freidlin, B.1    Korn, E.L.2
  • 45
    • 78649943187 scopus 로고    scopus 로고
    • The efficiency of clinical trial designs for predictive biomarker validation
    • Young KY, Laird A, Zhou XH. The efficiency of clinical trial designs for predictive biomarker validation. Clin Trials 2010;7:557-66.
    • (2010) Clin Trials , vol.7 , pp. 557-566
    • Young, K.Y.1    Laird, A.2    Zhou, X.H.3
  • 46
    • 79957786393 scopus 로고    scopus 로고
    • Biomarkers and the design of clinical trials in cancer
    • Fraser GA, Meyer RM. Biomarkers and the design of clinical trials in cancer. Biomark Med 2007;1:387-97.
    • (2007) Biomark Med , vol.1 , pp. 387-397
    • Fraser, G.A.1    Meyer, R.M.2
  • 47
    • 37349069551 scopus 로고    scopus 로고
    • Biomarker as a classifier in pharmacogenomics clinical trials: A tribute to 30th anniversary of PSI
    • Wang SJ. Biomarker as a classifier in pharmacogenomics clinical trials: a tribute to 30th anniversary of PSI. Pharm Stat 2007;6:283-96.
    • (2007) Pharm Stat , vol.6 , pp. 283-296
    • Wang, S.J.1
  • 48
    • 60549084162 scopus 로고    scopus 로고
    • Various randomized designs can be used to evaluate medical tests
    • Lijmer JG, Bossuyt PM. Various randomized designs can be used to evaluate medical tests. J Clin Epidemiol 2009;62:364-73.
    • (2009) J Clin Epidemiol , vol.62 , pp. 364-373
    • Lijmer, J.G.1    Bossuyt, P.M.2
  • 49
    • 33746205373 scopus 로고    scopus 로고
    • Clinical trials design and treatment tailoring: General principles applied to breast cancer research
    • DOI 10.1016/j.critrevonc.2005.11.003, PII S1040842805002271
    • Therasse P, Carbonnelle S, Bogaerts J. Clinical trials design and treatment tailoring: general principles applied to breast cancer research. Crit Rev Oncol Hematol 2006;59:98-105. (Pubitemid 44094104)
    • (2006) Critical Reviews in Oncology/Hematology , vol.59 , Issue.2 , pp. 98-105
    • Therasse, P.1    Carbonnelle, S.2    Bogaerts, J.3
  • 50
    • 78951495386 scopus 로고    scopus 로고
    • Why, when, and how should pharmacogenetics be applied in clinical studies?: Current and future approaches to study designs
    • Stingl Kirchheiner JC, Brockmoller J. Why, when, and how should pharmacogenetics be applied in clinical studies?: current and future approaches to study designs. Clin Pharmacol Ther 2011;89:198-209.
    • (2011) Clin Pharmacol Ther , vol.89 , pp. 198-209
    • Stingl Kirchheiner, J.C.1    Brockmoller, J.2
  • 51
    • 84855995271 scopus 로고    scopus 로고
    • A capture-recapture analysis demonstrated that randomized controlled trials evaluating the impact of diagnostic tests on patient outcomes are rare
    • Ferrante di RL, Davenport C, Eisinga A, Hyde C, Deeks JJ. A capture-recapture analysis demonstrated that randomized controlled trials evaluating the impact of diagnostic tests on patient outcomes are rare. J Clin Epidemiol 2012;65:282-7.
    • (2012) J Clin Epidemiol , vol.65 , pp. 282-287
    • Di Ferrante, R.L.1    Davenport, C.2    Eisinga, A.3    Hyde, C.4    Deeks, J.J.5
  • 52
    • 0036269892 scopus 로고    scopus 로고
    • Issues in clinical trial design for tumor marker studies
    • DOI 10.1053/sonc.2002.32898
    • Sargent D, Allegra C. Issues in clinical trial design for tumor marker studies. Semin Oncol 2002;29:222-30. (Pubitemid 34620439)
    • (2002) Seminars in Oncology , vol.29 , Issue.3 , pp. 222-230
    • Sargent, D.1    Allegra, C.2
  • 53
    • 15744374441 scopus 로고    scopus 로고
    • Clinical trial designs for predictive marker validation in cancer treatment trials
    • DOI 10.1200/JCO.2005.01.112
    • Sargent DJ, Conley BA, Allegra C, Collette L. Clinical trial designs for predictive marker validation in cancer treatment trials. J Clin Oncol 2005;23:2020-7. (Pubitemid 46211382)
    • (2005) Journal of Clinical Oncology , vol.23 , Issue.9 , pp. 2020-2027
    • Sargent, D.J.1    Conley, B.A.2    Allegra, C.3    Collette, L.4
  • 54
    • 78649932251 scopus 로고    scopus 로고
    • A threshold sample-enrichment approach in a clinical trial with heterogeneous subpopulations
    • Liu A, Liu C, Li Q, Yu KF, Yuan VW. A threshold sample-enrichment approach in a clinical trial with heterogeneous subpopulations. Clin Trials 2010;7:537-45.
    • (2010) Clin Trials , vol.7 , pp. 537-545
    • Liu, A.1    Liu, C.2    Li, Q.3    Yu, K.F.4    Yuan, V.W.5
  • 55
    • 66349125688 scopus 로고    scopus 로고
    • Adaptive patient enrichment designs in therapeutic trials
    • Wang SJ, Hung HM, O'Neill RT. Adaptive patient enrichment designs in therapeutic trials. Biom J 2009;51:358-74.
    • (2009) Biom J , vol.51 , pp. 358-374
    • Wang, S.J.1    Hung, H.M.2    O'Neill, R.T.3
  • 57
    • 10944237674 scopus 로고    scopus 로고
    • Evaluating markers for selecting a patient's treatment
    • DOI 10.1111/j.0006-341X.2004.00242.x
    • Song X, Pepe MS. Evaluating markers for selecting a patient's treatment. Biometrics 2004;60:874-83. (Pubitemid 40019028)
    • (2004) Biometrics , vol.60 , Issue.4 , pp. 874-883
    • Song, X.1    Pepe, M.S.2
  • 58
    • 73649102066 scopus 로고    scopus 로고
    • Additional patient outcomes and pathways in evaluations of testing
    • Nov 9. Rockville (MD): Agency for Healthcare Research and Quality (US); 2009-. Available from
    • Bossuyt PM, McCaffery K. Additional patient outcomes and pathways in evaluations of testing. 2009 Nov 9. In: Medical tests-white paper series [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2009-. Available from: http://www.ncbi.nlm.nih.gov/books/NBK49463/.
    • (2009) Medical Tests-white Paper Series [Internet]
    • Bossuyt, P.M.1    McCaffery, K.2
  • 59
    • 79959992818 scopus 로고    scopus 로고
    • Genomic markers to tailor treatments: Waiting or initiating?
    • Tajik P, Bossuyt PM. Genomic markers to tailor treatments: waiting or initiating? Hum Genet 2011;130:15-8.
    • (2011) Hum Genet , vol.130 , pp. 15-18
    • Tajik, P.1    Bossuyt, P.M.2
  • 60
    • 35948959022 scopus 로고    scopus 로고
    • Pharmacogenomic predictor discovery in phase II clinical trials for breast cancer
    • DOI 10.1158/1078-0432.CCR-07-0809
    • Pusztai L, Anderson K, Hess KR. Pharmacogenomic predictor discovery in phase II clinical trials for breast cancer. Clin Cancer Res 2007;13:6080-6. (Pubitemid 350075065)
    • (2007) Clinical Cancer Research , vol.13 , Issue.20 , pp. 6080-6086
    • Pusztai, L.1    Anderson, K.2    Hess, K.R.3
  • 62
    • 84857784212 scopus 로고    scopus 로고
    • Cancer biomarkers: Selecting the right drug for the right patient
    • Kelloff GJ, Sigman CC. Cancer biomarkers: selecting the right drug for the right patient. Nat Rev Drug Discov 2012;11:201-14.
    • (2012) Nat Rev Drug Discov , vol.11 , pp. 201-214
    • Kelloff, G.J.1    Sigman, C.C.2
  • 63
    • 84859721881 scopus 로고    scopus 로고
    • A two-stage Bayesian design for co-development of new drugs and companion diagnostics
    • Karuri SW, Simon R. A two-stage Bayesian design for co-development of new drugs and companion diagnostics. Stat Med 2012;31:901-14.
    • (2012) Stat Med , vol.31 , pp. 901-914
    • Karuri, S.W.1    Simon, R.2
  • 64
    • 84857144592 scopus 로고    scopus 로고
    • Predictive biomarkers in colorectal cancer: Usage, validation, and design in clinical trials
    • Shi Q, Mandrekar SJ, Sargent DJ. Predictive biomarkers in colorectal cancer: usage, validation, and design in clinical trials. Scand J Gastroenterol 2012;47:356-62.
    • (2012) Scand J Gastroenterol , vol.47 , pp. 356-362
    • Shi, Q.1    Mandrekar, S.J.2    Sargent, D.J.3
  • 66
    • 79952994872 scopus 로고    scopus 로고
    • All-comers versus enrichment design strategy in phase II trials
    • Mandrekar SJ, Sargent DJ. All-comers versus enrichment design strategy in phase II trials. J Thorac Oncol 2011;6:658-60.
    • (2011) J Thorac Oncol , vol.6 , pp. 658-660
    • Mandrekar, S.J.1    Sargent, D.J.2
  • 67
    • 84862843926 scopus 로고    scopus 로고
    • Design of clinical trials for biomarker research in oncology
    • Mandrekar SJ, Sargent DJ. Design of clinical trials for biomarker research in oncology. Clin Investig 2011;1:1629-36.
    • (2011) Clin Investig , vol.1 , pp. 1629-1636
    • Mandrekar, S.J.1    Sargent, D.J.2
  • 68
    • 79551557586 scopus 로고    scopus 로고
    • Incorporation of biomarker assessment in novel clinical trial designs: Personalizing brain tumor treatments
    • Galanis E, Wu W, Sarkaria J, Chang SM, Colman H, Sargent D, et al. Incorporation of biomarker assessment in novel clinical trial designs: personalizing brain tumor treatments. Curr Oncol Rep 2011;13:42-9.
    • (2011) Curr Oncol Rep , vol.13 , pp. 42-49
    • Galanis, E.1    Wu, W.2    Sarkaria, J.3    Chang, S.M.4    Colman, H.5    Sargent, D.6
  • 69
    • 78649965504 scopus 로고    scopus 로고
    • Clinical trials for predictive medicine: New challenges and paradigms
    • Simon R. Clinical trials for predictive medicine: new challenges and paradigms. Clin Trials 2010;7:516-24.
    • (2010) Clin Trials , vol.7 , pp. 516-524
    • Simon, R.1
  • 70
    • 79952271992 scopus 로고    scopus 로고
    • Advances in clinical trial designs for predictive biomarker discovery and validation
    • Simon R. Advances in clinical trial designs for predictive biomarker discovery and validation. Current Breast Cancer Reports 2009;1:216-21.
    • (2009) Current Breast Cancer Reports , vol.1 , pp. 216-221
    • Simon, R.1
  • 71
    • 77953472144 scopus 로고    scopus 로고
    • Genomic advances and their impact on clinical trial design
    • Mandrekar SJ, Sargent DJ. Genomic advances and their impact on clinical trial design. Genome Med 2009;1:69.
    • (2009) Genome Med , vol.1 , pp. 69
    • Mandrekar, S.J.1    Sargent, D.J.2
  • 72
    • 73949142341 scopus 로고    scopus 로고
    • Inference on treatment effects for targeted clinical trials under enrichment design
    • Liu JP, Lin JR, Chow SC. Inference on treatment effects for targeted clinical trials under enrichment design. Pharm Stat 2009;8:356-70.
    • (2009) Pharm Stat , vol.8 , pp. 356-370
    • Liu, J.P.1    Lin, J.R.2    Chow, S.C.3
  • 73
    • 67650440606 scopus 로고    scopus 로고
    • Design and adaptive analysis plans for pivotal clinical trials of therapeutics and companion diagnostics
    • DOI 10.1517/17530059.2.6.721
    • Simon R. Designs and adaptive analysis plans for pivotal clinical trials of therapeutics and companion diagnostics. Expert Opin Med Diagn 2008;2:721-9. (Pubitemid 351997859)
    • (2008) Expert Opinion on Medical Diagnostics , vol.2 , Issue.6 , pp. 721-729
    • Simon, R.1
  • 74
    • 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
  • 77
    • 58149163344 scopus 로고    scopus 로고
    • Statistical issues in translational cancer research
    • George SL. Statistical issues in translational cancer research. Clin Cancer Res 2008;14:5954-8.
    • (2008) Clin Cancer Res , vol.14 , pp. 5954-5958
    • George, S.L.1
  • 79
    • 84865406507 scopus 로고    scopus 로고
    • Practical perspectives of personalized healthcare in oncology
    • Hodgson DR, Wellings R, Harbron C. Practical perspectives of personalized healthcare in oncology. N Biotechnol 2012;29:656-64.
    • (2012) N Biotechnol , vol.29 , pp. 656-664
    • Hodgson, D.R.1    Wellings, R.2    Harbron, C.3
  • 80
    • 84868201754 scopus 로고    scopus 로고
    • From drug discovery to biomarker-driven clinical trials in lymphoma
    • Younes A, Berry DA. From drug discovery to biomarker-driven clinical trials in lymphoma. Nat Rev Clin Oncol 2012;9:643-53.
    • (2012) Nat Rev Clin Oncol , vol.9 , pp. 643-653
    • Younes, A.1    Berry, D.A.2
  • 81
    • 77953127347 scopus 로고    scopus 로고
    • Biomarkers and surrogate end points - The challenge of statistical validation
    • Buyse M, Sargent DJ, Grothey A, Matheson A, de GA. Biomarkers and surrogate end points-the challenge of statistical validation. Nat Rev Clin Oncol 2010;7:309-17.
    • (2010) Nat Rev Clin Oncol , vol.7 , pp. 309-317
    • Buyse, M.1    Sargent, D.J.2    Grothey, A.3    Matheson, A.4    De, G.A.5
  • 82
    • 33646047815 scopus 로고    scopus 로고
    • Use of genomic signatures in therapeutics development in oncology and other diseases
    • DOI 10.1038/sj.tpj.6500349, PII 6500349
    • Simon R, Wang SJ. Use of genomic signatures in therapeutics development in oncology and other diseases. Pharmacogenomics J 2006;6:166-73. (Pubitemid 43811567)
    • (2006) Pharmacogenomics Journal , vol.6 , Issue.3 , pp. 166-173
    • Simon, R.1    Wang, S.-J.2
  • 83
    • 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
  • 84
    • 80455173464 scopus 로고    scopus 로고
    • Adaptive clinical trial designs for simultaneous testing ofmatched diagnostics and therapeutics
    • Scher HI, Nasso SF, Rubin EH, Simon R. Adaptive clinical trial designs for simultaneous testing ofmatched diagnostics and therapeutics. Clin Cancer Res 2011;17:6634-40.
    • (2011) Clin Cancer Res , vol.17 , pp. 6634-6640
    • Scher, H.I.1    Nasso, S.F.2    Rubin, E.H.3    Simon, R.4
  • 85
    • 4344715880 scopus 로고    scopus 로고
    • Prognostic and predictive markers in cancer
    • Conley BA, Taube SE. Prognostic and predictive markers in cancer. Dis Markers 2004;20:35-43. (Pubitemid 39149913)
    • (2004) Disease Markers , vol.20 , Issue.2 , pp. 35-43
    • Conley, B.A.1    Taube, S.E.2
  • 87
    • 33744492349 scopus 로고    scopus 로고
    • Designing clinical trials for kidney cancer based on newly developed prognostic and predictive tools
    • DOI 10.1007/s11934-006-0032-y
    • Cho D, McDermott D, Atkins M. Designing clinical trials for kidney cancer based on newly developed prognostic and predictive tools. Curr Urol Rep 2006;7:8-15. (Pubitemid 44624025)
    • (2006) Current Urology Reports , vol.7 , Issue.1 , pp. 8-15
    • Cho, D.1    McDermott, D.2    Atkins, M.3
  • 88
    • 34547675933 scopus 로고    scopus 로고
    • An adaptive Simon Two-Stage Design for Phase 2 studies of targeted therapies
    • DOI 10.1016/j.cct.2007.02.008, PII S1551714407000353
    • Jones CL, Holmgren E. An adaptive Simon two-stage design for phase 2 studies of targeted therapies. Contemp Clin Trials 2007;28:654-61. (Pubitemid 47212846)
    • (2007) Contemporary Clinical Trials , vol.28 , Issue.5 , pp. 654-661
    • Jones, C.L.1    Holmgren, E.2
  • 89
    • 82355181790 scopus 로고    scopus 로고
    • Clinical trial design in the age of molecular profiling
    • Spira A, Edmiston KH. Clinical trial design in the age of molecular profiling. Methods Mol Biol 2012;823:19-34.
    • (2012) Methods Mol Biol , vol.823 , pp. 19-34
    • Spira, A.1    Edmiston, K.H.2
  • 90
    • 33646816049 scopus 로고    scopus 로고
    • Genome-based biomarkers for adverse drug effects, patient enrichment and prediction of drug response, and their incorporation into clinical trial design
    • White TJ, Clark AG, Broder S. Genome-based biomarkers for adverse drug effects, patient enrichment and prediction of drug response, and their incorporation into clinical trial design. Per Med 2006;3:177-85.
    • (2006) Per Med , vol.3 , pp. 177-185
    • White, T.J.1    Clark, A.G.2    Broder, S.3
  • 91
    • 78649918672 scopus 로고    scopus 로고
    • A Bayesian adaptive design with biomarkers for targeted therapies
    • Eickhoff JC, Kim K, Beach J, Kolesar JM, Gee JR. A Bayesian adaptive design with biomarkers for targeted therapies. Clin Trials 2010;7:546-56.
    • (2010) Clin Trials , vol.7 , pp. 546-556
    • Eickhoff, J.C.1    Kim, K.2    Beach, J.3    Kolesar, J.M.4    Gee, J.R.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.