Statistical approaches in oncology clinical development: current paradigm and methodological advancement

Description

Oncology is a rapidly developing area in medical science. A significant investment in terms of costs, resources and time is required for oncology drug development. Understanding of the challenges at all stages is vital for a successful drug launching. The purpose of this book is to provide an overview and practical solutions to some of these challenges which are commonly observed during setting up, conducting and reporting of oncology studies. This book will cover a wide variety of topics related to common challenges in cancer clinical trials across different stages of drug development.  Read more... Abstract: Oncology is a rapidly developing area in medical science. A significant investment in terms of costs, resources and time is required for oncology drug development. Understanding of the challenges at all stages is vital for a successful drug launching. The purpose of this book is to provide an overview and practical solutions to some of these challenges which are commonly observed during setting up, conducting and reporting of oncology studies. This book will cover a wide variety of topics related to common challenges in cancer clinical trials across different stages of drug development Content: Statistical considerations in phase I oncology trials / Simon Wandel and Satrajit Roychoudhury -- Exposure-response analysis in oncology trials / Yi-Lin Chiu and Balakrishna S. Hosmane -- Statistical measures of interaction for evaluating a predictive biomarker / Jaya Satgopan -- Design considerations for phase II oncology clinical trials / Jared C. Foster, Jennifer Le-Rademacher, and Sumithra J. Mandrekar -- Precision medicine and associated challenges / Rajesh Talluri and Sanjay Sathe -- Use of adaptive design in late-stage oncology trials / Satrajit Roychoudhur, Arunava Chakravartty, and Pabak Mukhopadhyay -- Safety monitoring and analysis in oncology trials / Anastasia Ivanova, Qi Jiang, Olga Marchenko, and Richard C. Zink -- Quality of life / Diane Fairclough -- Impact of evolving regulatory pathways on statistical considerations in oncology clinical trials / Rajeshwari Sridhara.