Clinical Trial Modernization: Technological, Operational, and Regulatory Advances

by Harry Yang, Liang Zhao

Overview

As the pharmaceutical industry navigates this new era of technological innovation, the integration of AI, big data, and advanced analytics into clinical trials holds immense potential to transform drug development. Clinical Trial Modernization: Technological, Operational, and Regulatory Advances provides a comprehensive overview of the current trends, challenges, and opportunities in modernizing clinical trials, offering a roadmap for stakeholders in this evolving field.

This book serves as a valuable resource for professionals, researchers, and regulators, providing actionable insights into the future of clinical trials and their critical role in bringing new therapies to market faster and more effectively.

Product Details

ISBN-13:	9781032123608
Publisher:	CRC Press
Publication date:	05/25/2025
Series:	Chapman & Hall/CRC Biostatistics Series
Pages:	434
Product dimensions:	6.12(w) x 9.19(h) x (d)

About the Author

Harry Yang, Ph.D., is Vice President of Biometrics at Recursion Pharmaceuticals. With over 25 years of experience in small molecule, biologics, and cellular immunotherapy development, his expertise spans the therapeutics areas of transplantation, vaccines, autoimmune and inflammatory disease, rare disease, and oncology. Dr. Yang is well-versed in innovative clinical trial design, regulatory submissions, and integration of real-world data, AI, and machine learning in drug R&D. He is a prolific author, having published 9 books and over 130 articles and book chapters covering critical statistical, scientific, and regulatory topics in drug R&D.

Liang Zhao, Ph.D., is Professor of Bioengineering and Therapeutic Sciences at University of California, San Francisco, following his role as the Director of Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards, Office of Generic Drugs, CDER/FDA. Dr. Zhao has introduced a broad array of innovative tools in drug deliveries, bioequivalence assessment, and pharmacometrics. He has published 100+ articles and book chapters and is the recipient of the 2023 Gary Neil Prive for Innovation in Drug Development from ASCPT.

Table of Contents

1 Transforming Clinical Trials through Harnessing Statistical and Technological Breakthroughs; 2 Digital Data Flow for Clinical Trials; 3 Enhancing Clinical Operations Efficiency and Effectiveness; 4 Quality by Design for Clinical Trials; 5 Clinical Trial Optimization; 6 Model- Informed Decision- Making in Clinical Trials; 7 AI-Assisted Data Analysis in Clinical Trials; 8 Regulatory Advances in Modernizing Clinical Trials; References