Biostatistics in Biopharmaceutical Research and Development: Clinical Trial Design, Volume 1

The Deming Conference on Applied Statistics has long been deemed an influential event in the biostatistics and biopharmaceutical profession. It provides learning experience on recent developments in statistical methodologies in biopharmaceutical applications and FDA regulations.

This book honors 80 years of contributions and dedication of the Deming Conference in biostatistics, and biopharmaceutical clinical trial methodology and applications. All chapters are contributed by world-class and prominent Deming speakers, who've contributed their cutting-edge research and developments to the community. Volume 1 covers Historical Milestones in Clinical Trial Design, FDA biopharmaceutical design guidance, and emerging development in Clinical Trial Design Methodology.

This book aims to booster research, education, and training in biostatistics and in biopharmaceutical research and development.

Chapter "Response-adaptive Randomization Designs Based on Optimal Allocation Proportion" is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.

• Format: Paperback
• ISBN: 3031659503
• ISBN13: 9783031659508
• Release Date: December 2025
• Publisher: Springer
• Length: 368 Pages
• Dimensions: 9.3" x 0.8" x 6.1"