TY - BOOK AU - Simon,Richard M. TI - Genomic clinical trials and predictive medicine T2 - Practical guides to biostatistics and epidemiology SN - 9781139026451 (ebook) AV - R853.C55 G46 2013 U1 - 610.72/4 23 PY - 2013/// CY - Cambridge PB - Cambridge University Press KW - Clinical trials KW - Statistical methods KW - Genomics KW - Tumor markers KW - Therapeutics, Experimental N1 - Title from publisher's bibliographic system (viewed on 05 Oct 2015); Clinical trial basics -- Actionable prognostic biomarkers -- Phase II designs -- Enrichment designs -- Including both test positive and test negative patients -- Adaptive threshold design -- Multiple predictive biomarkers predictive analysis of clinical trials -- Prospective : retrospective design N2 - Genomics is majorly impacting therapeutics development in medicine. This book contains up-to-date information on the use of genomics in the design and analysis of therapeutic clinical trials with a focus on novel approaches that provide a reliable basis for identifying which patients are most likely to benefit from each treatment. It is oriented to both clinical investigators and statisticians. For clinical investigators, it includes background information on clinical trial design and statistical analysis. For statisticians and others who want to go deeper, it covers state-of-the-art adaptive designs and the development and validation of probabilistic classifiers. The author describes the development and validation of prognostic and predictive biomarkers and their integration into clinical trials that establish their clinical utility for informing treatment decisions for future patients UR - https://doi.org/10.1017/CBO9781139026451 ER -