With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA’s recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology.
- Mark Chang, PhD, Statistician, Adjunct Professor, Co-founder of the International Society for Biopharmaceutical Statistics, Co-chair of the Biotechnology Industry Organization (BIO) Adaptive Design Working Group, Vice-President, Biometrics, AGAM Pharmaceuticals. Boston University, Boston, Lexington, MA (USA).
- Publisher: Chapman and Hall/CRC
- Publication date (print): 2011-12
- ISBN (print): 978-1-4398-3987-4
- ISBN (ebook PDF): 978-1-4398-3988-1