Digital Health Technologies for Drug Development: Practical Guide - Marta Karas

This book provides the first comprehensive, end-to-end guide to the use of Digital Health Technologies (DHTs) in clinical trials and drug development. DHTs, including wearable sensors and smartphone-based assessments, are transforming the way clinical evidence is generated throughout drug development. By enabling continuous, objective, and patient-centered measurement of physiology, behavior, and real-world functioning, these technologies are redefining clinical endpoints and expanding the possibilities of decentralized and data-driven clinical research. 
Bringing together contributions from statisticians, clinicians, data scientists, clinical operations leaders, regulatory experts, technology developers, and patients themselves, it follows the complete lifecycle of a digital measure - from identifying clinically meaningful concepts of interest and selecting fit-for-purpose technologies, to analytical validation, clinical validation, regulatory considerations, and implementation in global clinical trials.  
At its core is an extended treatment of data analysis methods, with chapters on signal processing, functional data analysis, dimensionality reduction and clustering, pattern segmentation, free-living smartphone data, endpoint validation, designs such as N-of-1 studies and micro-randomized trials, and pre-clinical applications. Dedicated chapters address the regulatory landscape, and the volume closes with perspectives from stakeholders across the ecosystem on where the field is heading. 
Serving as both a practical reference and a methodological guide, this volume is intended for researchers and professionals working in pharmaceutical and biotechnology companies, academia, contract research organizations, regulatory agencies, and digital health technology companies. It equips readers with the scientific, analytical, and operational foundations needed to successfully integrate digital health technologies into modern drug development and ultimately improve patient care.