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By Shigeyuki Matsui, Marc Buyse, Richard Simon

ISBN-10: 1466558164

ISBN-13: 9781466558168

An rising scientific trials paradigm for predictive drugs comprises the advance of molecular diagnostics to permit the prediction of the consequences of remedy or results of person sufferers. This publication bargains statistical advice on carrying out medical trials for predictive medication. It covers statistical themes correct to the most medical examine stages for constructing molecular diagnostics and Read more...

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36. Huang Y, Pepe MS, and Feng Z. Evaluating the predictiveness of a continuous marker. Biometrics, 2007; 63:1181–1188. 37. Pepe MS. The Statistical Evaluation of Medical Tests for Classification and Prediction. , 2003. 38. Gu W and Pepe M. Measures to summarize and compare the predictive capacity of markers. The International Journal of Biostatistics, October 1, 2009; 5(1):Article27. 39. Molinaro A, Simon R, and Pfeiffer R. Prediction error estimation: A comparison of resampling methods. Bioinformatics, 2005; 21:3301–3307.

FDA website, Washington, DC, 2004. 3. Oldenhuis CN, Oosting SF, Gietema JA et al. Prognostic vs predictive value of biomarkers in oncology. European Journal of Cancer, 2008; 44:946–953. 4. Atkinson AJ, Colburn WA, DeGruttola VG et al. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clinical Pharmacology Therapy, 2001; 69:89–95. 5. Kleinbaum DG, Sullivan KM, and Barker ND. A Pocket Guide to Epidemiology. Springer, New York, 2007. 6. NIH consensus conference. Treatment of early-stage breast cancer.

Drug companies have set ambitious goals around the delivery of personalized medicines to the patients. These goals have created an environment in which an increased focus is being given to the incorporation of predictive biomarkers into clinical development plans. Here we present some issues arising when evaluating diagnostics (Dx) in clinical development programs. One approach to such development is to incorporate the known biomarker (single or complex) into the clinical development program from the beginning, and design appropriate proof of concept (POC) experiments evaluating drug activity in diagnostically defined patient subsets.

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Design and Analysis of Clinical Trials for Predictive Medicine by Shigeyuki Matsui, Marc Buyse, Richard Simon

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