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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.
List of contents
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.
About the author
Christophe Le Tourneau has been appointed as a senior Medical Oncologist at the Curie Institute in 2009. He is heading the Phase I Program as well as the Head and Neck Clinic. He is also running a multicenter randomized personalized medicine trial (SHIVA). Christophe Le Tourneau was certified in Medical Oncology in 2005 and got his PhD in Clinical Epidemiology in 2007. He did a Clinical Research Fellowship at Princess Margaret Hospital in Toronto, Canada, in the Drug Development Program from November 2007 to November 2009. His main interest is drug development, the integration of genomic data for decision making and systems biology. Christophe Le Tourneau is the principal investigator of several phase I trials, as well as of clinical trials in Head and Neck oncology. He has published over 80 papers in peer-reviewed international journals. Maud Kamal, PhD is a scientific coordinator at Curie Institute. She has set up and coordinated clinical trials with scientific translational components (SHIVA trial and RAIDs European project (FP7) http://www.raids-fp7.eu/). She has published 29 papers in peer-reviewed international journals.
Summary
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.
