Section 1. Introductory overview -- section 2. Early clinical trials using biomarkers -- section 3. Phase III randomized clinical trials using biomarkers -- section 4. Analysis of high-dimensional data and genomic signature developments -- section 5. Randomized trials with biomarker development and validation -- section 6. Evaluation of surrogate biomarkers
Summary
An emerging clinical trials paradigm for predictive medicine involves the development of molecular diagnostics to enable the prediction of the effects of treatment or outcomes of individual patients. This book offers statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics. The book explains how to identify molecular biomarkers using DNA microarrays, validate the developed biomarkers, and confirm their clinical utility in randomized clinical trials
