Decision Making in a World of Comparative Effectiveness Research

Part I. Introduction

1. Introducing Decision Making in a World of Comparative Effectiveness Research

Howard G. Birnbaum, Paul E. Greenberg

2. Perspectives of Comparative Effectiveness Research from the World of Decision Making
Dave Nellesen, Howard G. Birnbaum, Paul E. Greenberg

Part II. The Future of Comparative Effectiveness Research for Evidence Developers: Perspectives from Pharmaceutical Decision Makers

3. Perspectives on the Use of Comparative Effectiveness Research by Life Sciences Executives: An Interview with Mike Bonney
Michael W. Bonney, Howard G. Birnbaum

4. Perspectives on the Use of Comparative Effectiveness Research by Life Sciences Executives: An Interview with a Senior Executive at an International Life Science Company
Howard G. Birnbaum, Francis Vekeman

5. Comparative Effectiveness Research: A Pharmaceutical Industry Perspective on Outlook, Dilemmas, and Controversies
Catherine Tak Piech, Patrick Lefebvre, Crystal T. Pike

6. Impact of Comparative Effectiveness Research on Drug Development Strategy and Innovation
Joshua P. Cohen, Joseph A. DiMasi, Kenneth I. Kaitin

7. Pricing of Pharmaceuticals: Current Trends and Outlook and the Role of Comparative Effectiveness Research
Christian Frois, Jens Grueger

Part III. Evolving Stakeholder Considerations: Patients, Physicians, Regulators and Payers

8. Are Real-World Data and Evidence Good Enough to Inform Health Care and Health Policy Decision-Making?
Marc L. Berger, James Harnett

9. Translating Comparative Effectiveness Research Evidence to Real-World Decision Making: Some Practical Considerations
Richard J. Willke

10. Decision-Making by Public Payers
Louis F. Rossiter

11. Patient and Stakeholder Engagement in Designing Pragmatic Clinical Trials
Anna Hung, Carole Baas, Justin Bekelman, Marcy Fitz-Randolph, C. Daniel Mullins

12. Policy Considerations: Ex-US Payers and Regulators
Jipan Xie, Kalipso Chalkidou, Isao Kamae, Rebecca E. Dittrich, Rifaiyat Mahbub, Arjun Vasan, Cinzia Metallo

13. Perspectives on the Common Drug Review Process at the Canadian Agency for Drugs and Technologies in Health
Patrick Lefebvre, Marie-Hélène Lafeuille, Sean Tiggelaar

14. Evaluating Non-Pharmaceutical Technologies at the Canadian Agency for Drugs and Technologies in Health
Patrick Lefebvre, Marie-Hélène Lafeuille, Sean Tiggelaar

15. Challenges and Opportunities in the Dissemination of Comparative Effectiveness Research Information to Physicians and Payers: A Legal Perspective
Mary E. Gately, Paul D. Schmitt

16. Legal Considerations in a World of Comparative Effectiveness Research
Paul Kalb, Paul E. Greenberg, Crystal T. Pike

Part IV. Emerging Challenges, Methods and Applications of Comparative Effectiveness Research: Real-World and Big Data

17. Application of Comparative Effectiveness Research to Promote Adherence to Clinical Practice Guidelines
Carl V. Asche, Stephen Hippler, Dean Eurich

18. Challenges in Developing and Assessing Comparative Effectiveness Evidence for Medical Technology
Richard Price, Genia Long

19. Evidence Generation Using Big Data: Challenges and Opportunities
Eberechukwu Onukwugha, Rahul Jain, Husam Albarmawi

20. Indirect Comparisons: A Brief History and a Practical Look Forward
James Signorovitch, Jie Zhang

21. Decision Making with Machine Learning in Our Modern, Data-Rich Health-Care Industry
Nick Dadson, Lisa Pinheiro, Jimmy Royer

Nyckelord: Medicine & Public Health, Pharmacoeconomics and Health Outcomes, Health Economics, Statistics for Life Sciences, Medicine, Health Sciences, Pharmaceutical Sciences/Technology