Introduction To Adaptive Trial Designs And Master Protocols
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Introduction to Adaptive Trial Designs and Master Protocols
Author: Jay J. H. Park
language: en
Publisher: Cambridge University Press
Release Date: 2023-04-06
This practical high-level guidebook offers an in-depth understanding of the newly emerging clinical trial designs in adaptive trial designs and master protocols. Both concise and readable without shying away from technical discussion, the book introduces the most innovative approaches in clinical trial research such as adaptive trial designs, master protocols, platform trial, basket trial, and umbrella trial designs. Featuring a revisionist history of clinical research before moving on to case-study based discussion and practical considerations from collective experience. The book enables readers to understand the strengths and limitations of these novel designs as well as their application to individual areas of research and clinical practice. Supplemented by real-world examples from the recent developments in medical research efficiency instigated by both personalized medicine and high-profile diseases like COVID-19 and cancer. The first book of its kind, it is the go-to resource for medical students and researchers working in clinical trial research.
Introduction to Adaptive Trial Designs and Master Protocols
Author: Jay J. H. Park
language: en
Publisher: Cambridge University Press
Release Date: 2023-04-06
A unique and practical high-level introductory guide to the emerging field of adaptive trial designs, platform trials, and master protocols.
Precision Medicine in Neurodegenerative Disorders
Precision Medicine in Neurodegenerative Disorders, Part Two, Volume 193 in the Handbook of Clinical Neurology deals with the "How" in the reconfiguration of our approach to slow accelerated brain aging. The book rethinks animal models on which therapies are tested, outlines the progress and expected changes in biological subtyping efforts using lysosomal, endosomal, mitochondrial, immune dysregulation, and inflammatory mechanisms of disease pathophysiology, and the growing role of microbiome in shaping disease. The volume separates the potentially disease-modifying neurorescue and neurorestoration, (e.g., gene therapy and cell replacement therapy) from true precision "medicine"–matching biology with the mechanism of intervention of interest. Specific chapters are dedicated to the promise and challenges of extracellular vesicles for both diagnosis and treatment, the growing application of digital measures and other evaluations of clinical response, the nuts and bolts of novel adaptive clinical trial designs, and the regulatory changes needed to facilitate drug development for disease-modification purposes. - Summarizes theory and research on precision medicine in neurodegenerative disorders - Covers basic biology, clinical trials and therapeutics - Includes disease mechanisms, genetic subtypes, and more