Bayesian Adaptive Design for Immunotherapy and Targeted Therapy

This book provides a comprehensive review of novel adaptive trial designs for targeted therapies and immunotherapies, with real-life examples and software to facilitate practitioners' learning and use.

Format: Hardback
Length: 262 pages
Publication date: 20 April 2023
Publisher: Springer Verlag, Singapore

This comprehensive book delves into the realm of innovative adaptive trial designs, specifically tailored for targeted therapies and immunotherapies. It encompasses a vast array of novel statistical approaches, catering to diverse clinical scenarios such as early phase dose-escalation studies, proof-of-concept trials, and confirmatory studies with regulatory implications. The book offers practical insights and hands-on guidance, featuring real-life examples and accompanying software, empowering practitioners to effectively grasp and apply these designs in their clinical practice.

Early Phase Dose-Escalation Studies:
Early phase dose-escalation studies play a crucial role in drug development, as they aim to determine the optimal dose and safety profile of a new therapeutic agent. Adaptive designs are particularly valuable in these studies, as they allow for flexible adjustments to the dose and study design based on accumulating data. The book explores various adaptive designs, including the Bayesian adaptive design, the stepped- wedge design, and the Latin square design, each with its unique advantages and applications.

Proof-of-Concept Trials:
Proof-of-concept trials are designed to establish the efficacy and safety of a new therapeutic approach in a small patient population. Adaptive designs are essential in these trials, as they enable rapid evaluation of the treatment effect and allow for early termination of ineffective treatments. The book discusses various proof-of-concept trial designs, including the phase II Simon design, the phase II basket design, and the phase III Simon design, each tailored to specific research objectives.

Confirmatory Studies with Registrational Intent:
Confirmatory studies with registrational intent are conducted to evaluate the efficacy and safety of a therapeutic agent in a larger patient population. Adaptive designs are crucial in these studies, as they allow for efficient sample size determination and adjustment based on accumulating data. The book explores various confirmatory study designs, including the phase III Simon design, the phase III basket design, and the phase III hybrid design, each designed to meet specific regulatory requirements.

Real-Life Examples and Software:
To enhance the practicality and accessibility of the information presented, the book includes real-life examples and software that facilitate practitioners' understanding and application of the adaptive trial designs. These examples and software provide a hands-on experience, allowing practitioners to apply the theoretical concepts to real-world clinical scenarios.

Conclusion:
This book serves as a valuable resource for researchers, clinicians, and regulatory professionals involved in the development and evaluation of targeted therapies and immunotherapies. By providing a comprehensive review of novel adaptive trial designs, it empowers practitioners to optimize study efficiency, enhance patient outcomes, and contribute to the advancement of medical research.

Weight: 582g
Dimension: 235 x 155 (mm)
ISBN-13: 9789811981746
Edition number: 1st ed. 2023