1st Edition

Real-World Evidence in a Patient-Centric Digital Era

Edited By Kelly H. Zou, Lobna A. Salem, Amrit Ray Copyright 2022
    208 Pages 17 B/W Illustrations
    by Chapman & Hall

    208 Pages 17 B/W Illustrations
    by Chapman & Hall

    Real-world evidence is defined as evidence generated from real-world data outside randomized controlled trials. As scientific discoveries and methodologies continue to advance, real-world data and their companion technologies offer powerful new tools for evidence generation. Real-World Evidence in a Patient-Centric Digital Era provides perspectives, examples, and insights on the innovative application of real-world evidence to meet patient needs and improve healthcare, with a focus on the pharmaceutical industry.

    This book presents an overview of key analytical issues and best practices. Special attention is paid to the development, methodologies, and other salient features of the statistical and data science techniques that are customarily used to generate real-world evidence. It provides a review of key topics and emerging trends in cutting-edge data science and health innovation.

    Features:

    • Provides an overview of statistical and analytic methodologies in real-world evidence to generate insights on healthcare, with a special focus on the pharmaceutical industry
    • Examines timely topics of high relevance to industry such as bioethical considerations, regulatory standards, and compliance requirements
    • Highlights emerging and current trends, and provides guidelines for best practices
    • Illustrates methods through examples and use-case studies to demonstrate impact
    • Provides guidance on software choices and digital applications for successful analytics

    Real-World Evidence in a Patient-Centric Digital Era will be a vital reference for medical researchers, health technology innovators, data scientists, epidemiologists, population health analysts, health economists, outcomes researchers, policymakers, and analysts in the healthcare industry.

    Preface: Real World Evidence and Digital Innovation to Combat Noncommunicable Diseases
    Kelly H. Zou, Lobna A. Salem, Joseph P. Cook, Anurita Majumdar and Amrit Ray

    1. Real World Evidence Generation
    Joseph S. Imperato, Joseph P. Cook, Diana Morgenstern, Kim Gilchrist, Tarek A. Hassan, Jorge Saenz and Danute Ducinskiene

    2. Applications of RWE for Regulatory Uses
    Eleanor E. Panico, Corinne S. Pillai, Ewa Filipowska and Kelly H. Zou

    3. Patient Data Privacy, Protected Health Information and Ethics of Real-World Evidence
    Corinne S. Pillai, Eleanor E. Panico, Kelly H. Zou and Ewa Filipowska

    4. Real-World Data, Big Data and Artificial Intelligence: Recent Development and Emerging Trends in the European Union
    Kelly H. Zou

    5. Patient Centricity and Precision Medicine
    Diana Morgenstern, Mina B. Riad, Claudia Zavala and Amrit Ray

    6. Health Information Technology
    Joseph P. Cook, Gabriel Jipa, Claudia Zavata and Lobna A. Salem

    7. Digital Health Technologies and Innovations
    Kelly H. Zou, Mina B. Riad, Shaantanu Donde, Joan van der Horn and Tarek A. Hassan

    8. Economic Analysis and Outcome Assessment
    Jean-Pascal Roussy and Kelly H. Zou

    9. Partnerships and Collaborations
    Salman Rizvi and Urooj A. Siddiqui

    10. Global Perspective: China Big Data Collaboration to Improve Patient Care
    Zhi Xia Xie, Jim Z. Li, Yvonne Huang, Olive Jin, Wei Yu and Kelly H. Zou

    11. The Future of Patient-Centric Data-Driven Healthcare
    Kelly H. Zou, Lobna A. Salem and Amrit Ray

    Biography

    Kelly H. Zou, Lobna A. Salem, Amrit Ray