February 9, 2018 In the past several years, the United States has struggled to respond to viral outbreaks, such as Ebola and Zika. There is now an awareness of the need to rapidly develop vaccines and treatments for epidemics that can quickly spread from country to country. But questions remain as how to best conduct clinical trials and development of vaccines in the context of an epidemic or outbreak. At this panel discussion, two health policy experts examined the appropriate conduct of clinical trials during public health emergencies. Learn more at: http://petrieflom.law.harvard.edu/events/details/clinical-trials-during-public-health-emergencies

1. Jason L. Schwartz, Ph.D., MBE
Assistant Professor
Department of Health Policy and Management,
Yale School of Public Health
Section of the History of Medicine,
Yale School of Medicine
Harvard Health Policy and Bioethics Consortium
9 February 2017
Clinical Trials and Public Health Emergencies

2. Overview
• (Brief) comments on debates about trial design
and randomization
• ‘Contextual’ Considerations – Pre-, Mid-, and
Post-Epidemic
1) Pre-epidemic research and collaboration
2) Infrastructure, coordination, and governance
3) Integrating research, response, and long-term
implementation issues
• Example: ongoing Ebola and Zika vaccine development

4. On Ebola and RCTs – Caplan, et al.
Caplan, Plunkett, and Levin, “Selecting the Right Tool for the Job,” American Journal of Bioethics, 2015.

5. 1. Pre-Epidemic Research and Collaboration

7. From CEPI.

8. 2. Infrastructure, Coordination, and Governance
• Investing in health systems and local infrastructure
– Robust public health surveillance systems
– Adequate numbers of trained health care personnel and
health care facilities
– For research activities, sufficient local expertise in clinical
research and ethics review and meaningful local
collaboration
– Coordination and clarity in distinguishing between
response- and research-centered activities
• Benefits of these investments extend well beyond single
clinical trial or response to a specific outbreak

9. From NASEM, 2017.

10. Gostin on Ebola,
WHO, and Global
Health Governance

11. Integrating Research, Response, and
Long-Term Implementation Issues
• Research and response/implementation as interconnected
activities:
– Narrow sense: co-existing during epidemic response
– Broader sense: insights from one shaping future directions in the other,
especially between epidemics
• Accordingly, value during drug/vaccine clinical research to
look ahead and plan ahead, e.g.:
– Who is going to make it?
– Who is going to pay for it?
– Who is going to receive it?
– Who is going to respond—or be held responsible—if something goes wrong
with it?

13. Ebola Vaccine, 2016-17

14. Zika Virus, 2015-

15. Recent Developments Related to Zika Virus

17. http://guidance.zikapregnancyethics.org/

18. Clinical Trials and Public Health Emergencies
Jason L. Schwartz, Ph.D., MBE
Assistant Professor
Department of Health Policy and Management,
Yale School of Public Health
Section of the History of Medicine,
Yale School of Medicine
Harvard Health Policy and Bioethics Consortium
9 February 2017