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1
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58149154725
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Validation of analytical methods for biomarkers employed in drug development
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Chau CH, Rixe O, McLeod H, Figg WD: Validation of analytical methods for biomarkers employed in drug development. Clin. Cancer Res. 14(19), 5967-5976 (2008).
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Clin. Cancer Res
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Chau, C.H.1
Rixe, O.2
McLeod, H.3
Figg, W.D.4
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3
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0033936550
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Time dependent ROC curves for censored survival data and a diagnostic marker
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Heagerty PJ, Lumley T, Pepe MS: Time dependent ROC curves for censored survival data and a diagnostic marker. Biometrics 56, 337-344 (2004).
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Biometrics
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Heagerty, P.J.1
Lumley, T.2
Pepe, M.S.3
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4
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33846978784
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Critical review of published microarray studies for cancer outcome and guidelines on statistical ana lysis and reporting
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Dupuy A, Simon R: Critical review of published microarray studies for cancer outcome and guidelines on statistical ana lysis and reporting. J. Natl Cancer Inst. 99, 147-157 (2007).
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(2007)
J. Natl Cancer Inst
, vol.99
, pp. 147-157
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Dupuy, A.1
Simon, R.2
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5
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0037245343
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Pitfalls in the use of DNA microarray data for diagnostic and prognostic classification
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Simon R, Radmacher MD, Dobbin K, McShane LM: Pitfalls in the use of DNA microarray data for diagnostic and prognostic classification. J. Natl Cancer Inst. 95, 14-18 (2003).
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J. Natl Cancer Inst
, vol.95
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Simon, R.1
Radmacher, M.D.2
Dobbin, K.3
McShane, L.M.4
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6
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25144494760
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Prediction error estimation: A comparison of resampling methods
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Molinaro AM, Simon R, Pfeiffer RM: Prediction error estimation: a comparison of resampling methods. Bioinformatics 21(15), 3301-3307 (2005).
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(2005)
Bioinformatics
, vol.21
, Issue.15
, pp. 3301-3307
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Molinaro, A.M.1
Simon, R.2
Pfeiffer, R.M.3
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7
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2942608807
-
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Springer Verlag, NY, USA
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Simon R, Korn EL, McShane LM, Radmacher MD, Wright GW, Zhao Y: Design and Ana lysis of DNA Microarray Investigations. Springer Verlag, NY, USA (2003).
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(2003)
Design and Ana lysis of DNA Microarray Investigations
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Simon, R.1
Korn, E.L.2
McShane, L.M.3
Radmacher, M.D.4
Wright, G.W.5
Zhao, Y.6
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8
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3543094382
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Perspectives and challenges of clinical pharmacogenomics in cancer
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Pusztai L: Perspectives and challenges of clinical pharmacogenomics in cancer. Pharmacogenomics 5(5), 451-454 (2004).
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Pharmacogenomics
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, Issue.5
, pp. 451-454
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Pusztai, L.1
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9
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0028318390
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Statistical aspects of prognostic factor studies in oncology
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Simon R, Altman DG: Statistical aspects of prognostic factor studies in oncology. Br. J. Cancer 69, 979-985 (1994).
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(1994)
Br. J. Cancer
, vol.69
, pp. 979-985
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Simon, R.1
Altman, D.G.2
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10
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33745641883
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Uses and abuses of tumor markers in the diagnosis, monitoring and treatment of primary and metastatic breast cancer
-
Henry NL, Hayes DF: Uses and abuses of tumor markers in the diagnosis, monitoring and treatment of primary and metastatic breast cancer. Oncologist 11, 541-552 (2006).
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Oncologist
, vol.11
, pp. 541-552
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Henry, N.L.1
Hayes, D.F.2
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11
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19944422061
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A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer
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Paik S, Shak S, Tang G et al.: A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N. Engl. J. Med. 351, 2817-2826 (2004).
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N. Engl. J. Med
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Paik, S.1
Shak, S.2
Tang, G.3
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12
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74049124050
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■ Provides a good case study of the development of an effective prognostic biomarker
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■ Provides a good case study of the development of an effective prognostic biomarker.
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-
-
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13
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34447132081
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Development and clinical utility of a 21-gene recurrence score prognostic assay in patients with early breast cancer treated with tamoxifen
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Paik S: Development and clinical utility of a 21-gene recurrence score prognostic assay in patients with early breast cancer treated with tamoxifen. Oncologist 12, 631-635 (2007).
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Oncologist
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Paik, S.1
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14
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2342571696
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Limitations of the odds ratio in guaging the performance of a diagnostic, prognostic or screening marker
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Pepe MS, Janes H, Longton G, Leisenring W, Newcomb P: Limitations of the odds ratio in guaging the performance of a diagnostic, prognostic or screening marker. Am. J. Epidemiol. 159, 882-890 (2004).
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Am. J. Epidemiol
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Pepe, M.S.1
Janes, H.2
Longton, G.3
Leisenring, W.4
Newcomb, P.5
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15
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74049101891
-
-
■ Important demonstration of the distinction between measures of association and measures of predictive accuracy
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■ Important demonstration of the distinction between measures of association and measures of predictive accuracy.
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-
-
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16
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18944384502
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When is a genomic classifier ready for prime time?
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Simon R: When is a genomic classifier ready for prime time? Nat. Clin. Pract. Oncol. 1(1), 2-3 (2004).
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(2004)
Nat. Clin. Pract. Oncol
, vol.1
, Issue.1
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Simon, R.1
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26444543829
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Clinical trial designs for prospective validation of biomarkers
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Mandrekar S, Grothey A, Goetz M, Sargent D: Clinical trial designs for prospective validation of biomarkers. Am. J. Pharmacogenomics 5(5), 317-325 (2005).
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Am. J. Pharmacogenomics
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Mandrekar, S.1
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18
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Randomized Phase III clinical trial designs for targeted agents
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Hoering A, Leblanc M, Crowley J: Randomized Phase III clinical trial designs for targeted agents. Clin. Cancer Res. 14(14), 4358-4367 (2008).
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Clin. Cancer Res
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Hoering, A.1
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19
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Clinical trial designs for predictive biomarker validation: One size does not fit all
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Mandrekar S, Sargent D: Clinical trial designs for predictive biomarker validation: one size does not fit all. J. Biopharm. Stat. 19, 530-542 (2009).
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Mandrekar, S.1
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20
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33750601244
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Gene signature evaluation as a prognostic tool: Challenges in the design of the MINDACT trial
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Bogaerts J, Cardoso F, Buyse M et al.: Gene signature evaluation as a prognostic tool: challenges in the design of the MINDACT trial. Nat. Clin. Pract. Oncol. 3(10), 540-551 (2006).
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Bogaerts, J.1
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21
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74049085664
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■ Good review of the design considerations for a prospective trial to validate a prognostic biomarker
-
■ Good review of the design considerations for a prospective trial to validate a prognostic biomarker.
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22
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39149113165
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Development of the 21-gene assay and its application in clinical practice and clinical trials
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Sparano JA, Paik S: Development of the 21-gene assay and its application in clinical practice and clinical trials. J. Clin. Oncol. 26(5), 721-728 (2008).
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Sparano, J.A.1
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23
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70449420123
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Use of archived specimens in evaluation of prognostic and predictive biomarkers
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Simon RM, Paik S, Hayes DF: Use of archived specimens in evaluation of prognostic and predictive biomarkers. Natl Cancer Inst. 101(21), 1446-1452 (2009).
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Natl Cancer Inst
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Simon, R.M.1
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24
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54049129625
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Pivotal evaluation of the accuracy of a classification biomarker: The probe study design
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Pepe MS, Feng Z, Janes H, Bossuyt PM, Potter J: Pivotal evaluation of the accuracy of a classification biomarker: the probe study design. J. Natl Cancer Inst. 100, 432-438 (2008).
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Potter, J.5
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25
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74049162235
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-
■ Important paper on an improved approach to the design of studies for the evaluation of biomarkers used for early disease detection
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■ Important paper on an improved approach to the design of studies for the evaluation of biomarkers used for early disease detection.
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26
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27244446214
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Prognostic and predictive factors revisited
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Hayes DF: Prognostic and predictive factors revisited. Breast 14, 493-499 (2005).
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Breast
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Hayes, D.F.1
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38049103907
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HER2 status and efficacy of adjuvant anthracyclines in early breast cancer: A pooled ana lysis of randomized clinical trials
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Gennari A, Sormani MP, Pronzato P et al.: HER2 status and efficacy of adjuvant anthracyclines in early breast cancer: a pooled ana lysis of randomized clinical trials. J. Natl Cancer Inst. 100(1), 14-20 (2008).
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J. Natl Cancer Inst
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Gennari, A.1
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35248895346
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HER2 and response to paclitaxel in node-positive breast cancer
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Hayes DF, Thor AD, Dressler LG et al.: HER2 and response to paclitaxel in node-positive breast cancer. N. Engl. J. Med. 357, 1496-1506 (2007).
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Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer
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Kras mutations and benefit from cetuximab in advanced colorectal cancer
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Karapetis CS, Khambata-Ford S, Jonker DJ et al.: Kras mutations and benefit from cetuximab in advanced colorectal cancer. N. Engl. J. Med. 359(17), 1757-1765 (2008).
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31
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33847147313
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American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer
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Wolff AC, Hammond EH, Schwartz JN et al.: American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J. Clin. Oncol. 25(1), 118-145 (2007).
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The cancer biomarker problem
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Nature
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Sawyers, C.L.1
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33
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74049122724
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■■ Very useful review of the importance and challenges in the development of predictive biomarkers
-
■■ Very useful review of the importance and challenges in the development of predictive biomarkers.
-
-
-
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34
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6044278144
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Evaluating the efficiency of targeted designs for randomized clinical trials
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Simon R, Maitournam A: Evaluating the efficiency of targeted designs for randomized clinical trials. Clin. Cancer Res. 10, 6759-6763 (2005).
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Clin. Cancer Res
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Simon, R.1
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35
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74049109915
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■■ Quantitative evaluation of the efficiency of targeted enrichment designs
-
■■ Quantitative evaluation of the efficiency of targeted enrichment designs.
-
-
-
-
36
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33744828667
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Evaluating the efficiency of targeted designs for randomized clinical trials: Supplement and correction
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Simon R, Maitournam A: Evaluating the efficiency of targeted designs for randomized clinical trials: supplement and correction. Clin. Cancer Res. 12, 3229 (2006).
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Clin. Cancer Res
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Simon, R.1
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13644270099
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On the efficiency of targeted clinical trials
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Maitournam A, Simon R: On the efficiency of targeted clinical trials. Stat. Med. 24, 329-339 (2005).
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Stat. Med
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Maitournam, A.1
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58149151278
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Using genomics in clinical trial design
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Simon R: Using genomics in clinical trial design. Clin. Cancer Res. 14, 5984-5993 (2008).
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Clin. Cancer Res
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Simon, R.1
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39
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74049163974
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■■ Provides a roadmap for the prospective validation of predictive biomarkers
-
■■ Provides a roadmap for the prospective validation of predictive biomarkers.
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-
-
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40
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67650440606
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Designs and adaptive ana lysis plans for pivotal clinical trials of therapeutics and companion diagnostics
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Simon R: Designs and adaptive ana lysis plans for pivotal clinical trials of therapeutics and companion diagnostics. Expert Rev. Mol. Diagn. 2(6), 721-729 (2008).
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Expert Rev. Mol. Diagn
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Simon, R.1
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41
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56949103832
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Use of genomic signatures in therapeutics development
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Simon R, Wang SJ: Use of genomic signatures in therapeutics development. Pharmacogenomics J. 6, 1667-1173 (2006).
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Pharmacogenomics J
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Simon, R.1
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Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset
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Wang SJ, O'Neill RT, Hung HMJ: Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset. Pharm. Stat. 6, 227-244 (2007).
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Pharm. Stat
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Wang, S.J.1
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74049118228
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A threshold sample-enrichment approach in a clinical trial with heterogeneous subpopulations
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In press
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Liu A, Li Q, Yu KF, Yuan VW: A threshold sample-enrichment approach in a clinical trial with heterogeneous subpopulations. Stat. Med. (2009) (In press).
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Stat. Med
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Liu, A.1
Li, Q.2
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44
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34447264769
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Biomarker adaptive threshold design: A procedure for evaluating treatment with possible biomarker-defined subset effect
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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. 99, 1036-1043 (2007).
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J. Natl Cancer Inst
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Jiang, W.1
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27744537954
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Adaptive signature design: An adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients
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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. 11, 7872-7878 (2005).
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Clin. Cancer Res
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Freidlin, B.1
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34547529442
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A method for testing a prespecified subgroup in clinical trials
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Song Y, Chi GYH: A method for testing a prespecified subgroup in clinical trials. Stat. Med. 26, 3535-3549 (2007).
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Song, Y.1
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