Clinical and statistical considerations in personalized medicine

"Personalized medicine has the potential to change the way we think about, identify, and manage health problems. In the pharmaceutical industry, it is already having an exciting impact on both clinical research and patient care. This impact will continue to grow as our understanding and technologies improve. With contributions from well-known industry leaders in clinical development, this book covers the practical aspects of personalized medicine, focusing on issues that have direct application in the industry. Topics include designs for targeted therapy, adaptive designs, evidence-based adaptive statistical decisions, and design strategies for maximizing the efficiency of clinical oncology"-- "Preface The successful utilization of biomarkers in clinical development and, indeed, realization of personalized medicine require a close collaboration among different stakeholders: clinicians, biostatisticians, regulators, commercial colleagues, and so on. For this reason, we invited experts from different fields of expertise to address the opportunities and challenges, and discuss recent advancements related to biomarkers and their translation into clinical development. The first four cha