Ethical Issues in Clinical Trial Designs for Ebola Treatment and Prevention: Reflections on Studies Conducted in 2015

Carl Coleman, Professor, Seton Hall University

Abstract: Clinical trials for Ebola relied on a wide range of study designs, each of which had strong defenders and critics. Some researchers and ethicists strongly defended the use of randomized controlled trials, arguing that this study design had the greatest potential to generate usable scientific information. Others argued that, for a disease with extremely high mortality rates and no proven treatments, it was unethical to assign some participants to a control group that would receive supportive care only. Instead, they supported the use of single-arm studies that compared outcomes to historical controls. While most of the ethical debates focused on trials for potentially curative treatments, concerns were also raised about vaccine trials in which some individuals considered at high risk of infection were given immediate vaccination while others at comparable risk were vaccinated after 21 days. This presentation will reflect on the ethical debates over Ebola clinical trials and consider the implications of these debates for future epidemic outbreaks.

Webcast link: https://jcb.adobeconnect.com/bioethicsseminars/