Simulation and Deliberation to Prepare for Clinical Trials in Infectious Disease Emergencies: Digital Health @ Harvard Series
Infectious disease emergencies are opportunities to test the efficacy of newly developed interventions (e.g. drugs, vaccines and treatment regimens), yet they raise many intertwined challenges of politics, logistics, ethics, and study design. Consistent with the efforts of CEPI, WHO, and others to encourage development and Phase I/II testing of candidate vaccines (the focus of this talk) in advance of emergencies, it is essential before the emergency strikes to advance the discussion of how such products can and should be tested. This can help to disentangle ethical from political and logistical concerns, reduce the time pressure to make a decision, and encourage rational deliberation by future stakeholders who at the time of deliberation do not know what role (which product, which field site) they may be supporting in an actual emergency.
At this luncheon, Professor Marc Lipsitch described his work on computer simulation of vaccine trials during epidemics to assess options for trial design, as well as some of his recent work on the ethics of trials in emergencies, with the aim to stimulate discussion on the intersection of these two topics.
This event was free and open to the public.
Dr. Marc Lipsitch is a Professor of Epidemiology at the Harvard T. H. Chan School of Public Health with a primary appointment in the Department of Epidemiology and a joint appointment in the Department of Immunology and Infectious Diseases. He also directs the Center for Communicable Disease Dynamics, a center of excellence funded by the MIDAS program of NIH/NIGMS, and the Associate Director of the Interdisciplinary Concentration in Infectious Disease Epidemiology. His research concerns the effect of naturally acquired host immunity, vaccine-induced immunity and other public health interventions (e.g. antimicrobial use) on the population biology of pathogens and the consequences of changing pathogen populations for human health. Some of this work is motivated mainly by practical questions in public health (such as vaccine design and intervention targeting), and some is motivated by classical questions in population biology, such as how to explain patterns of coexistence of pathogen strains in space and time. Dr. Lipsitch received his BA in philosophy from Yale University, completed his doctoral work in zoology at Oxford University as a Rhodes Scholar and did postdoctoral work at Emory University and at the CDC from 1995-1999. He joined the faculty of Harvard School of Public Health in 1999.
The Digital Health @ Harvard series features speakers from Harvard as well as collaborators and colleagues from other institutions who research the intersection between health and digital technology. The series is cosponsored by the Berkman Klein Center for Internet & Society at Harvard University and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. The goal of the series is to discuss ongoing research in this research area, share new developments, identify opportunities for collaboration, and explore the digital health ecosystem more generally.
- Mark Lipsitch: "Simulation and Deliberation to Prepare for Clinical Trials in Infectious Disease Emergencies"