-
1
-
-
0036269892
-
Issues in clinical trial design for tumor marker studies
-
Sargent D, Allegra C. Issues in clinical trial design for tumor marker studies. Seminars in Oncology 2002; 29(3):222-230.
-
(2002)
Seminars in Oncology
, vol.29
, Issue.3
, pp. 222-230
-
-
Sargent, D.1
Allegra, C.2
-
2
-
-
6044278144
-
Evaluating the efficiency of targeted designs for randomized clinical trials
-
Simon R, Maitournam A. Evaluating the efficiency of targeted designs for randomized clinical trials. Clinical Cancer Research 2004; 10:6759-6763.
-
(2004)
Clinical Cancer Research
, vol.10
, pp. 6759-6763
-
-
Simon, R.1
Maitournam, A.2
-
3
-
-
56949087846
-
Lost in translation: problems and pitfalls in translating laboratory observations to clinical utility
-
Simon R. Lost in translation: problems and pitfalls in translating laboratory observations to clinical utility. European Journal of Cancer 2008; 44(18):2707-2713.
-
(2008)
European Journal of Cancer
, vol.44
, Issue.18
, pp. 2707-2713
-
-
Simon, R.1
-
5
-
-
27744537954
-
Adaptive signature design: an adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients
-
Freidlin B, Simon R. Adaptive signature design: an adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients. Clinical Cancer Research 2005; 1(11):7872-7878.
-
(2005)
Clinical Cancer Research
, vol.1
, Issue.11
, pp. 7872-7878
-
-
Freidlin, B.1
Simon, R.2
-
6
-
-
26444543829
-
Clinical trial designs for prospective validation of biomarkers
-
Mandrekar S, Grothey A, Goetz M, Sargent D. Clinical trial designs for prospective validation of biomarkers. American Journal of Pharmacogenomics 2005; 5(5):317-325.
-
(2005)
American Journal of Pharmacogenomics
, vol.5
, Issue.5
, pp. 317-325
-
-
Mandrekar, S.1
Grothey, A.2
Goetz, M.3
Sargent, D.4
-
7
-
-
15744374441
-
Clinical trial designs for predictive marker validation in cancer treatment trials
-
Sargent D, Conley B, Allegra C, Collette L. Clinical trial designs for predictive marker validation in cancer treatment trials. Journal of Clinical Oncology 2005; 23(9):2020-2027.
-
(2005)
Journal of Clinical Oncology
, vol.23
, Issue.9
, pp. 2020-2027
-
-
Sargent, D.1
Conley, B.2
Allegra, C.3
Collette, L.4
-
8
-
-
33646047815
-
The use of genomic signatures in therapeutics development in oncology and other diseases
-
Simon R, Wang S. The use of genomic signatures in therapeutics development in oncology and other diseases. Pharmacogenomics Journal 2006; 6(3):166-173.
-
(2006)
Pharmacogenomics Journal
, vol.6
, Issue.3
, pp. 166-173
-
-
Simon, R.1
Wang, S.2
-
9
-
-
34447264769
-
Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect
-
Jiang W, Freidlin B, Simon R. Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect. Journal of the National Cancer Institute 2007; 99:1036-1043.
-
(2007)
Journal of the National Cancer Institute
, vol.99
, pp. 1036-1043
-
-
Jiang, W.1
Freidlin, B.2
Simon, R.3
-
10
-
-
35348814333
-
Development and validation of biomarker classifiers for treatment selection
-
Simon R. Development and validation of biomarker classifiers for treatment selection. Journal of Statistical Planning and Inference 2008; 138(2):308-320.
-
(2008)
Journal of Statistical Planning and Inference
, vol.138
, Issue.2
, pp. 308-320
-
-
Simon, R.1
-
11
-
-
60549084162
-
Various randomized designs can be used to evaluate medical tests
-
Lijmer J, Bossuyt P. Various randomized designs can be used to evaluate medical tests. Journal of Clinical Epidemiology 2009; 62(4):364-373.
-
(2009)
Journal of Clinical Epidemiology
, vol.62
, Issue.4
, pp. 364-373
-
-
Lijmer, J.1
Bossuyt, P.2
-
12
-
-
67651030311
-
Clinical trial designs for predictive biomarker validation: one size does not fit all
-
Mandrekar S, Sargent D. Clinical trial designs for predictive biomarker validation: one size does not fit all. Journal of Biopharmaceutical Statistics 2009; 19:530-542.
-
(2009)
Journal of Biopharmaceutical Statistics
, vol.19
, pp. 530-542
-
-
Mandrekar, S.1
Sargent, D.2
-
13
-
-
70449420123
-
Use of archived specimens in evaluation of prognostic and predictive biomarkers
-
Simon R, Paik S, Hayes D. Use of archived specimens in evaluation of prognostic and predictive biomarkers. Journal of the National Cancer Institute 2009; 101:1446-1452.
-
(2009)
Journal of the National Cancer Institute
, vol.101
, pp. 1446-1452
-
-
Simon, R.1
Paik, S.2
Hayes, D.3
-
14
-
-
70449370331
-
A perspective on challenges and issues in biomarker development and drug and biomarker codevelopment
-
Taube S, Clark G, Dancey J, McShane L, Sigman C, Gutman S. A perspective on challenges and issues in biomarker development and drug and biomarker codevelopment. Journal of the National Cancer Institute 2009; 101:1453-1463.
-
(2009)
Journal of the National Cancer Institute
, vol.101
, pp. 1453-1463
-
-
Taube, S.1
Clark, G.2
Dancey, J.3
McShane, L.4
Sigman, C.5
Gutman, S.6
-
15
-
-
69849108427
-
Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges
-
Mandrekar S, Sargent D. Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges. Journal of Clinical Oncology 2009; 24(24):4027-4034.
-
(2009)
Journal of Clinical Oncology
, vol.24
, Issue.24
, pp. 4027-4034
-
-
Mandrekar, S.1
Sargent, D.2
-
16
-
-
84867133676
-
Biostatistical considerations in development of biomarker-based tests to guide treatment decisions
-
Clark G, McShane L. Biostatistical considerations in development of biomarker-based tests to guide treatment decisions. Statistics in Biopharmaceutical Research 2011; 3:549-560.
-
(2011)
Statistics in Biopharmaceutical Research
, vol.3
, pp. 549-560
-
-
Clark, G.1
McShane, L.2
-
17
-
-
78649923786
-
Predictive biomarker validation in practice: lessons from real trials
-
Mandrekar S, Sargent D. Predictive biomarker validation in practice: lessons from real trials. Clinical Trials 2010; 7:567-573.
-
(2010)
Clinical Trials
, vol.7
, pp. 567-573
-
-
Mandrekar, S.1
Sargent, D.2
-
18
-
-
84890122240
-
Statistical challenges in the development and evaluation of marker-based clinical tests
-
McShane L. Statistical challenges in the development and evaluation of marker-based clinical tests. BMC Medicine 2012; 10:52.
-
(2012)
BMC Medicine
, vol.10
, pp. 52
-
-
McShane, L.1
-
20
-
-
84883483981
-
Trial designs for personalizing cancer care: a systematic review and classification
-
Tajik P, Zwinderman AH, Mol BW, Bossuyt PM. Trial designs for personalizing cancer care: a systematic review and classification. Clinical Cancer Research 2013; 19:4578-4588.
-
(2013)
Clinical Cancer Research
, vol.19
, pp. 4578-4588
-
-
Tajik, P.1
Zwinderman, A.H.2
Mol, B.W.3
Bossuyt, P.M.4
-
21
-
-
79951611991
-
Measuring the performance of markers for guiding treatment decisions
-
Janes H, Pepe MS, Bossuyt PM, Barlow WE. Measuring the performance of markers for guiding treatment decisions. Annals of Internal Medicine 2011; 154(4):253-259.
-
(2011)
Annals of Internal Medicine
, vol.154
, Issue.4
, pp. 253-259
-
-
Janes, H.1
Pepe, M.S.2
Bossuyt, P.M.3
Barlow, W.E.4
-
22
-
-
84866749582
-
Assessing treatment-selection markers using a potential outcomes framework
-
Huang Y, Gilbert PB, Janes H. Assessing treatment-selection markers using a potential outcomes framework. Biometrics 2012; 68(3):687-696.
-
(2012)
Biometrics
, vol.68
, Issue.3
, pp. 687-696
-
-
Huang, Y.1
Gilbert, P.B.2
Janes, H.3
-
23
-
-
10944237674
-
Evaluating markers for selecting a patient's treatment
-
Song X, Pepe MS. Evaluating markers for selecting a patient's treatment. Biometrics 2004; 60(4):874-883.
-
(2004)
Biometrics
, vol.60
, Issue.4
, pp. 874-883
-
-
Song, X.1
Pepe, M.S.2
-
24
-
-
77953005977
-
A generalized estimator of the attributable benefit of an optimal treatment regime
-
Brinkley J, Tsiatis AA, Anstrom KJ. A generalized estimator of the attributable benefit of an optimal treatment regime. Biometrics 2010; 66:512-522.
-
(2010)
Biometrics
, vol.66
, pp. 512-522
-
-
Brinkley, J.1
Tsiatis, A.A.2
Anstrom, K.J.3
-
28
-
-
19344364880
-
Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomized trials
-
Early Breast Cancer Trialists Collaborative Group . Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomized trials. Lancet 2005; 365:1687-1717.
-
(2005)
Lancet
, vol.365
, pp. 1687-1717
-
-
-
29
-
-
40349103608
-
International Web-based consultation on priorities for translational breast cancer research
-
Dowsett M, Goldhirsch A, Hayes DF, Senn HJ, Wood W, Viale G. International Web-based consultation on priorities for translational breast cancer research. Breast Cancer Research 2007; 9:R81.
-
(2007)
Breast Cancer Research
, vol.9
, pp. R81
-
-
Dowsett, M.1
Goldhirsch, A.2
Hayes, D.F.3
Senn, H.J.4
Wood, W.5
Viale, G.6
-
30
-
-
19944422061
-
A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer
-
Paik S, Shak S, Tang G, Kim C, Baker J, Cronin M, Baehner FL, Walker MG, Watson D, Park T, Hiller W, Fisher ER, Wickerham DL, Bryant J, Wolmark N. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. New England Journal of Medicine 2004; 351(27):2817-2826.
-
(2004)
New England Journal of Medicine
, vol.351
, Issue.27
, pp. 2817-2826
-
-
Paik, S.1
Shak, S.2
Tang, G.3
Kim, C.4
Baker, J.5
Cronin, M.6
Baehner, F.L.7
Walker, M.G.8
Watson, D.9
Park, T.10
Hiller, W.11
Fisher, E.R.12
Wickerham, D.L.13
Bryant, J.14
Wolmark, N.15
-
31
-
-
33744814477
-
Gene expression and benefit of chemotherapy in women with node-negative, estrogen-receptor-positive breast cancer
-
Paik S, Tang G, Shak S, Chungyeul K, Baker J, Kim W, Cronin M, Baehner FL, Watson D, Bryant J, Constantino JP, Geyer CE Jr., Wickerham DL, Wolmark N. Gene expression and benefit of chemotherapy in women with node-negative, estrogen-receptor-positive breast cancer. Journal of Clinical Oncology 2006; 24:3726-3734.
-
(2006)
Journal of Clinical Oncology
, vol.24
, pp. 3726-3734
-
-
Paik, S.1
Tang, G.2
Shak, S.3
Chungyeul, K.4
Baker, J.5
Kim, W.6
Cronin, M.7
Baehner, F.L.8
Watson, D.9
Bryant, J.10
Constantino, J.P.11
Geyer, C.J.12
Wickerham, D.L.13
Wolmark, N.14
-
32
-
-
73249140371
-
Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomized trial
-
Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh IT. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomized trial. Lancet Oncology 2010; 11:55-65.
-
(2010)
Lancet Oncology
, vol.11
, pp. 55-65
-
-
Albain, K.S.1
Barlow, W.E.2
Shak, S.3
Hortobagyi, G.N.4
Livingston, R.B.5
Yeh, I.T.6
-
33
-
-
84893821653
-
A framework for evaluating markers used to select patient treatment
-
Janes H, Pepe MS, Huang Y. A framework for evaluating markers used to select patient treatment. Medical Decision Making 2013; 34:159-167.
-
(2013)
Medical Decision Making
, vol.34
, pp. 159-167
-
-
Janes, H.1
Pepe, M.S.2
Huang, Y.3
-
34
-
-
72149104757
-
Adjuvant chemotherapy and timing of tamoxifen in postmenopausal patients with endocrine-responsive, node-positive breast cancer: a phase 3, open-label, randomized controlled trial
-
for The Breast Cancer Intergroup of North America
-
Albain KS, Barlow WE, Davdin PM, Farrar WB, Burton GV, Ketchel SJ, Cobau CD, Levine EG, Ingle JN, Pritchard KI, Lichter AS, Schneider DJ, Abeloff MD, Henderson IC, Muss HB, Green SJ, Lew D, Livingston RB, Martino S, Osborne CK, for The Breast Cancer Intergroup of North America. Adjuvant chemotherapy and timing of tamoxifen in postmenopausal patients with endocrine-responsive, node-positive breast cancer: a phase 3, open-label, randomized controlled trial. Lancet 2009; 274:2055-2063.
-
(2009)
Lancet
, vol.274
, pp. 2055-2063
-
-
Albain, K.S.1
Barlow, W.E.2
Davdin, P.M.3
Farrar, W.B.4
Burton, G.V.5
Ketchel, S.J.6
Cobau, C.D.7
Levine, E.G.8
Ingle, J.N.9
Pritchard, K.I.10
Lichter, A.S.11
Schneider, D.J.12
Abeloff, M.D.13
Henderson, I.C.14
Muss, H.B.15
Green, S.J.16
Lew, D.17
Livingston, R.B.18
Martino, S.19
Osborne, C.K.20
more..
-
35
-
-
34447646946
-
Method for evaluating prediction models that apply the results of randomized trials to individual patients
-
Vickers AJ, Kattan MW, Sargent D. Method for evaluating prediction models that apply the results of randomized trials to individual patients. Trials 2007; 8:14.
-
(2007)
Trials
, vol.8
, pp. 14
-
-
Vickers, A.J.1
Kattan, M.W.2
Sargent, D.3
-
36
-
-
10944260135
-
Clinical trial design for microarray predictive marker discovery and assessment
-
Pusztai L, Hess KR. Clinical trial design for microarray predictive marker discovery and assessment. Annals of Oncology 2004; 15:1731-1737.
-
(2004)
Annals of Oncology
, vol.15
, pp. 1731-1737
-
-
Pusztai, L.1
Hess, K.R.2
-
37
-
-
84866768285
-
The use of genomics in clinical trial design
-
Simon R. The use of genomics in clinical trial design. Clinical Cancer Research 2008; 14:5954-5958.
-
(2008)
Clinical Cancer Research
, vol.14
, pp. 5954-5958
-
-
Simon, R.1
-
38
-
-
39149123547
-
Clinical application of the 70-gene profile: the MINDACT trial
-
Cardoso F, Van'tVeer L, Rutgers E, Loi S, Mook S, Piccart-Gebhart MJ. Clinical application of the 70-gene profile: the MINDACT trial. Journal of Clinical Oncology 2008; 26:729-735.
-
(2008)
Journal of Clinical Oncology
, vol.26
, pp. 729-735
-
-
Cardoso, F.1
Van'tVeer, L.2
Rutgers, E.3
Loi, S.4
Mook, S.5
Piccart-Gebhart, M.J.6
-
39
-
-
33750895236
-
TAILORx: trial assigning individualized options for treatment (Rx)
-
Sparano JA. TAILORx: trial assigning individualized options for treatment (Rx). Clinical Breast Cancer 2006; 7:347-350.
-
(2006)
Clinical Breast Cancer
, vol.7
, pp. 347-350
-
-
Sparano, J.A.1
-
40
-
-
44349162031
-
-
Design of a Clinical Trial for Testing the Ability of a Continuous Marker to Predict Therapy Benefit. Chapman and Hall/CRC: Boca Raton, FL
-
Barlow WE. Handbook of Statistics in Clinical Oncology. Design of a Clinical Trial for Testing the Ability of a Continuous Marker to Predict Therapy Benefit. Chapman and Hall/CRC: Boca Raton, FL, 2012.
-
(2012)
Handbook of Statistics in Clinical Oncology
-
-
Barlow, W.E.1
-
41
-
-
79959992818
-
Genomic markers to tailor treatments: waiting or initiating?
-
Tajik P, Bossuyt PM. Genomic markers to tailor treatments: waiting or initiating? Human Genetics 2011; 130:15-18.
-
(2011)
Human Genetics
, vol.130
, pp. 15-18
-
-
Tajik, P.1
Bossuyt, P.M.2
|