Clinical trial designs for evaluating the medical utility of prognostic and predictive biomarkers in oncology.
暂无分享,去创建一个
[1] George Y H Chi,et al. A method for testing a prespecified subgroup in clinical trials , 2007, Statistics in medicine.
[2] Holly Janes,et al. Pivotal Evaluation of the Accuracy of a Biomarker Used for Classification or Prediction: Standards for Study Design , 2008, Journal of the National Cancer Institute.
[3] R. Simon,et al. On the efficiency of targeted clinical trials , 2005, Statistics in medicine.
[4] M. Pepe. The Statistical Evaluation of Medical Tests for Classification and Prediction , 2003 .
[5] Dongsheng Tu,et al. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. , 2008, The New England journal of medicine.
[6] R. Simon,et al. Evaluating the Efficiency of Targeted Designs for Randomized Clinical Trials , 2004, Clinical Cancer Research.
[7] Soonmyung Paik,et al. Use of archived specimens in evaluation of prognostic and predictive biomarkers. , 2009, Journal of the National Cancer Institute.
[8] A. Dupuy,et al. Critical review of published microarray studies for cancer outcome and guidelines on statistical analysis and reporting. , 2007, Journal of the National Cancer Institute.
[9] G. Bepler,et al. Increased Bioavailability of Intravenous Versus Oral CI-1033, a Pan erbB Tyrosine Kinase Inhibitor: Results of a Phase I Pharmacokinetic Study , 2006, Clinical Cancer Research.
[10] D. Hayes,et al. Uses and abuses of tumor markers in the diagnosis, monitoring, and treatment of primary and metastatic breast cancer. , 2006, The oncologist.
[11] R. Venkatraman. HER2 status and efficacy of adjuvant anthracyclines in early breast cancer: A pooled analysis of randomized trials , 2008 .
[12] T. Lumley,et al. Time‐Dependent ROC Curves for Censored Survival Data and a Diagnostic Marker , 2000, Biometrics.
[13] S. Paik. Development and clinical utility of a 21-gene recurrence score prognostic assay in patients with early breast cancer treated with tamoxifen. , 2007, The oncologist.
[14] M. Radmacher,et al. Pitfalls in the use of DNA microarray data for diagnostic and prognostic classification. , 2003, Journal of the National Cancer Institute.
[15] L. Pusztai. Perspectives and challenges of clinical pharmacogenomics in cancer. , 2004, Pharmacogenomics.
[16] J. Minna,et al. The impact of epidermal-growth-factor-receptor mutations in response to lung-cancer therapy , 2004, Nature Clinical Practice Oncology.
[17] D. Sargent,et al. Clinical Trial Designs for Prospective Validation of Biomarkers , 2005, American journal of pharmacogenomics : genomics-related research in drug development and clinical practice.
[18] Marc Buyse,et al. Gene signature evaluation as a prognostic tool: challenges in the design of the MINDACT trial , 2006, Nature Clinical Practice Oncology.
[19] M. Sormani,et al. HER2 status and efficacy of adjuvant anthracyclines in early breast cancer: a pooled analysis of randomized trials. , 2008, Journal of the National Cancer Institute.
[20] Larry Norton,et al. HER2 and response to paclitaxel in node-positive breast cancer. , 2007, The New England journal of medicine.
[21] S. Paik,et al. Development of the 21-gene assay and its application in clinical practice and clinical trials. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.
[22] R. Simon,et al. Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect. , 2007, Journal of the National Cancer Institute.
[23] M Richard Simon,et al. Design and Analysis of DNA Microarray Investigations , 2004 .
[24] M. Cronin,et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. , 2004, The New England journal of medicine.
[25] William D. Figg,et al. Validation of Analytic Methods for Biomarkers Used in Drug Development , 2008, Clinical Cancer Research.
[26] Annette M. Molinaro,et al. Prediction error estimation: a comparison of resampling methods , 2005, Bioinform..
[27] K. Yu,et al. A threshold sample-enrichment approach in a clinical trial with heterogeneous subpopulations , 2010, Clinical trials.
[28] Richard Simon,et al. When is a genomic classifier ready for prime time? , 2004, Nature Clinical Practice Oncology.
[29] Gary Longton,et al. Limitations of the Odds Ratio in Gauging the Performance of a Diagnostic or Prognostic Marker , 2004 .
[30] R. Simon,et al. Designs and adaptive analysis plans for pivotal clinical trials of therapeutics and companion diagnostics. , 2008, Expert opinion on medical diagnostics.
[31] C. Sawyers. The cancer biomarker problem , 2008, Nature.
[32] Daniel F Hayes,et al. Prognostic and predictive factors revisited. , 2005, Breast.
[33] D. G. Altman,et al. Statistical aspects of prognostic factor studies in oncology. , 1994, British Journal of Cancer.
[34] Daniel J Sargent,et al. Clinical Trial Designs for Predictive Biomarker Validation: One Size Does Not Fit All , 2009, Journal of biopharmaceutical statistics.
[35] R. Simon,et al. Use of genomic signatures in therapeutics development in oncology and other diseases , 2006, The Pharmacogenomics Journal.
[36] Sue-Jane Wang,et al. Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset , 2007, Pharmaceutical statistics.
[37] Anthony Rhodes,et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. , 2007, Archives of pathology & laboratory medicine.
[38] F.A.M. Bordonaba,et al. Wild-Type KRAS Is Required for Panitumumab Efficacy in Patients With Metastatic Colorectal Cancer , 2009 .
[39] Antje Hoering,et al. Randomized Phase III Clinical Trial Designs for Targeted Agents , 2008, Clinical Cancer Research.
[40] R. Simon,et al. Adaptive Signature Design: An Adaptive Clinical Trial Design for Generating and Prospectively Testing A Gene Expression Signature for Sensitive Patients , 2005, Clinical Cancer Research.
[41] Robert Gentleman. Design and Analysis of DNA Microarray Investigations , 2005 .
[42] Richard Simon,et al. The Use of Genomics in Clinical Trial Design , 2008, Clinical Cancer Research.