Case Studies in Innovative Clinical Trials

Written by pharmaceutical industry experts, academic researchers, and regulatory reviewers, this is the first book providing a comprehensive set of case studies related to statistical methodology, implementation, regulatory considerations, and communication of complex innovative trial design; Has a broad appeal to a multitude of readers across academia, industry, and regulatory agencies; Each contribution is a practical case study that can speak to the benefits of an innovative approach but also balance that with the real-life challenges encountered; A complete understanding of what is actually being done in modern clinical trials will broaden the reader’s capabilities and provide examples to first mimic and then customize and expand upon when exploring these ideas on their own.