This original book provides readers with an overview of the latest developments in personalized medicine clinical trials in oncology. The topics covered range from the rationale behind this new generation of clinical trials and the latest statistical models for high-throughput molecular techniques, bioinformatics, high-throughput screening molecular techniques and the challenges entailed by implementing them in daily practice. It also covers the key role of pathology in the validation of molecular results and the complex assessment of predictive biomarkers. The different topics covered are supplemented by unique concrete examples based on the SHIVA trial. The authors are all members of the French Curie Institute, one of the world's foremost cancer research institutions.
Introduction: Rationale for Precision Medicine Clinical Trials.- The Key Role of Pathology in the Context of Precision Medicine Trials.- Basis for Molecular Genetics in Cancer.- Microarrays Based Molecular Profiling to Identify Genomic Alterations.- High Throughput Technologies: DNA and RNA Sequencing Strategies and Potential.- Bioinformatics for Precision Medicine in Oncology.- Assessment of Biomarkers' Predictive Value of Efficacy.- Designs for Evaluating Precision Medicine Trials.- Conclusions and Perspectives: Challenges for the Clinical Implementation of Precision Medicine Trials.