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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.

Biomarkers, Tumor --- Neoplasms --- Precision Medicine --- Research Design --- Data Adjustment --- Data Reporting --- Design, Experimental --- Designs, Experimental --- Error Sources --- Experimental Designs --- Matched Groups --- Methodology, Research --- Problem Formulation --- Research Methodology --- Research Proposal --- Research Strategy --- Research Technics --- Research Techniques --- Scoring Methods --- Experimental Design --- Adjustment, Data --- Adjustments, Data --- Data Adjustments --- Design, Research --- Designs, Research --- Error Source --- Formulation, Problem --- Formulations, Problem --- Group, Matched --- Groups, Matched --- Matched Group --- Method, Scoring --- Methods, Scoring --- Problem Formulations --- Proposal, Research --- Proposals, Research --- Reporting, Data --- Research Designs --- Research Proposals --- Research Strategies --- Research Technic --- Research Technique --- Scoring Method --- Source, Error --- Sources, Error --- Strategies, Research --- Strategy, Research --- Technic, Research --- Technics, Research --- Technique, Research --- Techniques, Research --- Research --- Clinical Trials Data Monitoring Committees --- genetics --- methods --- Genomics --- Clinical trials. --- Medicine, Preventive. --- Disease prevention --- Diseases --- Prevention of disease --- Preventive medicine --- Pathology --- Preventive health services --- Preventive medicine physicians --- Public health --- Controlled clinical trials --- Patient trials of new treatments --- Randomized clinical trials --- Trials, Clinical --- Clinical medicine --- Human experimentation in medicine --- Genome research --- Genomes --- Molecular genetics --- Statistical methods. --- Prevention --- Clinical trials --- Tumor markers --- Therapeutics, Experimental --- Experimental therapeutics --- Medicine, Experimental --- Biological markers (Oncology) --- Cancer markers --- Markers, Tumor --- Tumor associated markers --- Biochemical markers --- Tumors