Model-Assisted Bayesian Designs for Dose Finding and Optimization: Methods and Applications

Bayesian adaptive designs are crucial for improving drug development efficiency and success, particularly in early phase trials. This book provides a comprehensive coverage of model-assisted designs for various types of dose-finding and optimization clinical trials, with practical challenges, issues, and solutions. It offers step-by-step illustrations of using software to design trials and develops a companion website to assist learning and implementing these designs. Written by internationally recognized research leaders, the book demonstrates how model-assisted designs can greatly improve the efficiency and simplify the design, conduct, and optimization of early-phase dose-finding trials.

Format: Hardback
Length: 220 pages
Publication date: 11 November 2022
Publisher: Taylor & Francis Ltd

Bayesian adaptive designs play a pivotal role in enhancing the efficiency and success of drug development, as recognized by the US Food and Drug Administration (FDA). This significance is particularly evident in early phase trials, as they lay the foundation for subsequent phase II and III trials. The primary objective of this book is to elucidate the cutting-edge model-assisted designs that facilitate and expedite the adoption of novel adaptive designs for early phase clinical trials. Model-assisted designs boast remarkable features that blend superiority with simplicity. While their decision rules may be complex, they can often be pre-tabulated and incorporated into the protocol, rendering implementation akin to conventional algorithm-based designs. An exemplar is the Bayesian optimal interval (BOIN) design, the first dose-finding design to receive the fit-for-purpose designation from the FDA. This designation underscores the regulatory agency's strong endorsement of the novel adaptive design's potential to revolutionize drug development.

This book stands as the first comprehensive resource dedicated to model-assisted designs for diverse types of dose-finding and optimization clinical trials. It delves into the latest theoretical developments and practical applications in this field. Moreover, it addresses numerous challenges, issues, and solutions encountered during early-phase clinical trials, providing valuable insights and solutions. Numerous real-world trial applications are showcased to illustrate the practical implications of model-assisted designs. Additionally, the book offers numerous tips and guidance on designing dose-finding and optimization trials, accompanied by step-by-step illustrations of using software to facilitate trial design. Furthermore, a companion website (www.trialdesign.org) is developed to provide freely accessible, user-friendly software tools for designing trials.

In summary, this book serves as a valuable resource for researchers, practitioners, and regulatory professionals involved in drug development. It empowers them with the knowledge and tools necessary to employ model-assisted designs effectively, thereby accelerating the translation of scientific discoveries into clinically meaningful treatments.

Weight: 590g
Dimension: 234 x 156 (mm)
ISBN-13: 9780367146245