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Volumn 3 DEC, Issue , 2013, Pages

Drug-diagnostics co-development in oncology

Author keywords

Adaptive design; Clinical trial design; Companion diagnostic; Enrichment trial; Predictive biomarker

Indexed keywords

DRUG DESIGN; DRUG FORMULATION; DRUG SCREENING; GENETIC HETEROGENEITY; GENOMICS; HUMAN; ONCOLOGY; PATIENT MONITORING; REVIEW; TREATMENT RESPONSE;

EID: 84892409041     PISSN: None     EISSN: 2234943X     Source Type: Journal    
DOI: 10.3389/fonc.2013.00315     Document Type: Review
Times cited : (9)

References (29)
  • 1
    • 41649102043 scopus 로고    scopus 로고
    • The cancer biomarker problem
    • doi: 10.1038/nature06913
    • Sawyers CL. The cancer biomarker problem. Nature (2008) 452:548-52. doi: 10.1038/nature06913.
    • (2008) Nature , vol.452 , pp. 548-52
    • Sawyers, C.L.1
  • 3
    • 27744449733 scopus 로고    scopus 로고
    • An agenda for clinical trials: clinical trials in the genomic era
    • doi:10.1191/1740774504cn046xx
    • Simon R. An agenda for clinical trials: clinical trials in the genomic era. Clin Trials (2004) 1:468-70. doi:10.1191/1740774504cn046xx.
    • (2004) Clin Trials , vol.1 , pp. 468-70
    • Simon, R.1
  • 4
    • 34249295235 scopus 로고    scopus 로고
    • New challenges for 21st century clinical trials
    • doi:10.1177/1740774507076800
    • Simon R. New challenges for 21st century clinical trials. Clin Trials (2007) 4:167-9. doi:10.1177/1740774507076800.
    • (2007) Clin Trials , vol.4 , pp. 167-9
    • Simon, R.1
  • 5
    • 6044278144 scopus 로고    scopus 로고
    • Evaluating the efficiency of targeted designs for randomized clinical trials
    • doi:10.1158/1078-0432.CCR-04-0496
    • Simon R, Maitournam A. Evaluating the efficiency of targeted designs for randomized clinical trials. Clin Cancer Res (2005) 10:6759-63. doi:10.1158/1078-0432.CCR-04-0496.
    • (2005) Clin Cancer Res , vol.10 , pp. 6759-63
    • Simon, R.1    Maitournam, A.2
  • 6
    • 33744828667 scopus 로고    scopus 로고
    • Evaluating the efficiency of targeted designs for randomized clinical trials: supplement and correction
    • doi:10.1158/1078-0432.CCR-12-10-COR
    • Simon R, Maitournam A. Evaluating the efficiency of targeted designs for randomized clinical trials: supplement and correction. Clin Cancer Res (2006) 12:3229. doi:10.1158/1078-0432.CCR-12-10-COR.
    • (2006) Clin Cancer Res , vol.12 , pp. 3229
    • Simon, R.1    Maitournam, A.2
  • 7
    • 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. doi:10.1002/sim.1975.
    • (2005) Stat Med , vol.24 , pp. 329-39
    • Maitournam, A.1    Simon, R.2
  • 8
    • 51649085832 scopus 로고    scopus 로고
    • Randomized phase III clinical trial designs for targeted agents
    • doi:10.1158/1078-0432.CCR-08-0288
    • Hoering A, LeBlanc M, Crowley J. Randomized phase III clinical trial designs for targeted agents. Clin Cancer Res (2008) 14:4358-67. doi:10.1158/1078-0432.CCR-08-0288.
    • (2008) Clin Cancer Res , vol.14 , pp. 4358-67
    • Hoering, A.1    LeBlanc, M.2    Crowley, J.3
  • 9
    • 69849108427 scopus 로고    scopus 로고
    • Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges
    • doi:10.1200/JCO.2009.22.3701
    • Mandrekar SJ, Sargent DJ. Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges. J Clin Oncol (2009) 27:4027-34. doi:10.1200/JCO.2009.22.3701.
    • (2009) J Clin Oncol , vol.27 , pp. 4027-34
    • Mandrekar, S.J.1    Sargent, D.J.2
  • 10
    • 84880206315 scopus 로고    scopus 로고
    • Clinical trials for precision oncology using next generation sequencing
    • doi:10.2217/pme.13.36
    • Simon R, Polley E. Clinical trials for precision oncology using next generation sequencing. Per Med (2013) 10:485-95. doi:10.2217/pme.13.36.
    • (2013) Per Med , vol.10 , pp. 485-95
    • Simon, R.1    Polley, E.2
  • 11
    • 58149151278 scopus 로고    scopus 로고
    • Using genomics in clinical trial design
    • doi:10.1158/1078-0432.CCR-07-4531
    • Simon R. Using genomics in clinical trial design. Clin Cancer Res (2008) 14:5984-93. doi:10.1158/1078-0432.CCR-07-4531.
    • (2008) Clin Cancer Res , vol.14 , pp. 5984-93
    • Simon, R.1
  • 12
    • 84886553300 scopus 로고    scopus 로고
    • Phase III clinical trials that integrate treatment and biomarker evaluation
    • doi:10.1200/JCO.2012.48.3826
    • Freidlin B, Sun Z, Gray R, Korn EL. Phase III clinical trials that integrate treatment and biomarker evaluation. J Clin Oncol (2013) 31:3158-61. doi:10.1200/JCO.2012.48.3826.
    • (2013) J Clin Oncol , vol.31 , pp. 3158-61
    • Freidlin, B.1    Sun, Z.2    Gray, R.3    Korn, E.L.4
  • 13
    • 33646047815 scopus 로고    scopus 로고
    • Use of genomic signatures in therapeutics development
    • doi:10.1038/sj.tpj.6500349
    • Simon R, Wang SJ. Use of genomic signatures in therapeutics development. Pharmacogenomcs J (2006) 6:1667-1173. doi:10.1038/sj.tpj.6500349.
    • (2006) Pharmacogenomcs J , vol.6 , pp. 1667-1173
    • Simon, R.1    Wang, S.J.2
  • 14
    • 34648840242 scopus 로고    scopus 로고
    • Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset
    • doi:10.1002/pst.300
    • Wang SJ, O'Neill RT, Hung HM. Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset. Pharm Stat (2007) 6:227-44. doi:10.1002/pst.300.
    • (2007) Pharm Stat , vol.6 , pp. 227-44
    • Wang, S.J.1    O'Neill, R.T.2    Hung, H.M.3
  • 15
    • 76349100026 scopus 로고    scopus 로고
    • Randomized clinical trials with biomarkers: design issues
    • doi:10.1093/jnci/djp477
    • Freidlin B, McShane LM, Korn EL. Randomized clinical trials with biomarkers: design issues. J Natl Cancer Inst (2010) 102:152-60. doi:10.1093/jnci/djp477.
    • (2010) J Natl Cancer Inst , vol.102 , pp. 152-60
    • Freidlin, B.1    McShane, L.M.2    Korn, E.L.3
  • 16
    • 78649923786 scopus 로고    scopus 로고
    • Predictive biomarker validation in practice: lessons from real trials
    • doi:10.1177/1740774510368574
    • Mandrekar SJ, Sargent DJ. Predictive biomarker validation in practice: lessons from real trials. Clin Trials (2010) 7:567-73. doi:10.1177/1740774510368574.
    • (2010) Clin Trials , vol.7 , pp. 567-73
    • Mandrekar, S.J.1    Sargent, D.J.2
  • 17
    • 84866615115 scopus 로고    scopus 로고
    • Randomized phase II trial designs with biomarkers
    • doi:10.1200/JCO.2012.43.3946
    • Freidlin B, McShane LM, Polley MY, Korn EL. Randomized phase II trial designs with biomarkers. J Clin Oncol (2012) 28:3304-9. doi:10.1200/JCO.2012.43.3946.
    • (2012) J Clin Oncol , vol.28 , pp. 3304-9
    • Freidlin, B.1    McShane, L.M.2    Polley, M.Y.3    Korn, E.L.4
  • 18
    • 84859721881 scopus 로고    scopus 로고
    • A two-stage Bayesian design for co-development of new drugs and companion diagnostics
    • doi:10.1002/sim.4462
    • Karuri SW, Simon R. A two-stage Bayesian design for co-development of new drugs and companion diagnostics. Stat Med (2012) 31:901-14. doi:10.1002/sim.4462.
    • (2012) Stat Med , vol.31 , pp. 901-14
    • Karuri, S.W.1    Simon, R.2
  • 19
    • 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
    • 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. doi:10.1093/jnci/djm022.
    • (2007) J Natl Cancer Inst , vol.99 , pp. 1036-43
    • Jiang, W.1    Freidlin, B.2    Simon, R.3
  • 20
    • 84888318018 scopus 로고    scopus 로고
    • Adaptive enrichment designs in clinical trials
    • doi:10.1093/biostatistics/kxt010
    • Simon N, Simon R. Adaptive enrichment designs in clinical trials. Biostatistics (2013) 14:613-25. doi:10.1093/biostatistics/kxt010.
    • (2013) Biostatistics , vol.14 , pp. 613-25
    • Simon, N.1    Simon, R.2
  • 21
    • 66349125688 scopus 로고    scopus 로고
    • Adaptive patient enrichment designs in therapeutic trials
    • doi:10.1002/bimj.200900003
    • Wang SJ, Hung HM, O'Neill RT. Adaptive patient enrichment designs in therapeutic trials. Biom J (2009) 51:358-74. doi:10.1002/bimj.200900003.
    • (2009) Biom J , vol.51 , pp. 358-74
    • Wang, S.J.1    Hung, H.M.2    O'Neill, R.T.3
  • 22
    • 0031322659 scopus 로고    scopus 로고
    • Adaptively changing subgroup proportions in clinical trials
    • Follman D. Adaptively changing subgroup proportions in clinical trials. Stat Sin (1997) 7:1085-102.
    • (1997) Stat Sin , vol.7 , pp. 1085-102
    • Follman, D.1
  • 23
    • 82255183905 scopus 로고    scopus 로고
    • Optimizing randomized trial designs to distinguish which subpopulations benefit from treatment
    • doi:10.1093/biomet/asr055
    • Rosenblum M, Van der Laan MJ. Optimizing randomized trial designs to distinguish which subpopulations benefit from treatment. Biometrika (2011) 98:845-60. doi:10.1093/biomet/asr055.
    • (2011) Biometrika , vol.98 , pp. 845-60
    • Rosenblum, M.1    Van der Laan, M.J.2
  • 24
    • 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. doi:10.1158/1078-0432.CCR-05-0605.
    • (2005) Clin Cancer Res , vol.11 , pp. 7872-8
    • Freidlin, B.1    Simon, R.2
  • 25
    • 78650100317 scopus 로고    scopus 로고
    • Impacts on type I error rate with inappropriate use of learn and confirm in confirmatory adaptive design trials
    • doi:10.1002/bimj.200900207
    • Wang SJ, Hung HM, O'Neill RT. Impacts on type I error rate with inappropriate use of learn and confirm in confirmatory adaptive design trials. Biom J (2010) 52:798-810. doi:10.1002/bimj.200900207.
    • (2010) Biom J , vol.52 , pp. 798-810
    • Wang, S.J.1    Hung, H.M.2    O'Neill, R.T.3
  • 26
    • 80455173464 scopus 로고    scopus 로고
    • Adaptive clinical trials for simultaneous testing of matched diagnostics and therapeutics
    • doi:10.1158/1078-0432.CCR-11-1105
    • Sher HI, Nasso NF, Rubin E, Simon R. Adaptive clinical trials for simultaneous testing of matched diagnostics and therapeutics. Clin Cancer Res (2011) 17:6634-40. doi:10.1158/1078-0432.CCR-11-1105.
    • (2011) Clin Cancer Res , vol.17 , pp. 6634-40
    • Sher, H.I.1    Nasso, N.F.2    Rubin, E.3    Simon, R.4
  • 27
    • 84868574658 scopus 로고    scopus 로고
    • Developing and validating continuous genomic signatures in randomized clinical trials for predictive medicine
    • doi:10.1158/1078-0432.CCR-12-1206
    • Matsui S, Simon R, Qu P, Shaughnessy JD, Barlogie B, Crowley J. Developing and validating continuous genomic signatures in randomized clinical trials for predictive medicine. Clin Cancer Res (2012) 18:6065-73. doi:10.1158/1078-0432.CCR-12-1206.
    • (2012) Clin Cancer Res , vol.18 , pp. 6065-73
    • Matsui, S.1    Simon, R.2    Qu, P.3    Shaughnessy, J.D.4    Barlogie, B.5    Crowley, J.6
  • 28
    • 84888134117 scopus 로고    scopus 로고
    • Bayesian two-step lasso strategy for biomarker selection in personalized medicine development for time to event endpoints
    • doi:10.1016/j.cct.2013.09.009
    • Gu X, Yin G, Lee JJ. Bayesian two-step lasso strategy for biomarker selection in personalized medicine development for time to event endpoints. Contemp Clin Trials (2013) 36:642-50. doi:10.1016/j.cct.2013.09.009.
    • (2013) Contemp Clin Trials , vol.36 , pp. 642-50
    • Gu, X.1    Yin, G.2    Lee, J.J.3
  • 29
    • 74549207384 scopus 로고    scopus 로고
    • The cross-validated adaptive signature design for predictive analysis of clinical trials
    • doi:10.1158/1078-0432.CCR-09-1357
    • Freidlin B, Jiang W, Simon R. The cross-validated adaptive signature design for predictive analysis of clinical trials. Clin Cancer Res (2010) 16:691-8. doi:10.1158/1078-0432.CCR-09-1357.
    • (2010) Clin Cancer Res , vol.16 , pp. 691-8
    • Freidlin, B.1    Jiang, W.2    Simon, R.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.