1st Edition
Real-World Evidence in a Patient-Centric Digital Era
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