Lisa Schwartz, who recently accepted an appointment to the World Health Organization’s (WHO) Ethics Working Group on Ebola Interventions, is among the experts who are advising the WHO on ethical issues related to the study design for trials on therapeutics being developed to fight the disease.
Schwartz also recently joined the Médecins Sans Frontières (MSF) Ethics Review Board.
Schwartz, the Arnold L. Johnson Chair in Health Care Ethics at McMaster, Director of McMaster’s PhD in Health Policy program and co-associate director of McMaster’s Centre for Health Economics and Policy Analysis (CHEPA), was among members of the WHO’s Ethics Working Group summoned by the organization to Geneva, Switzerland late last month to explore the ethical considerations in the implementation of clinical trials for therapeutics to ensure that investigators, regulators and the policy makers all have a common understanding of the issues and the challenges in developing ethically- and scientifically-sound study designs that can be effectively implemented in West Africa for evaluation of potential therapeutic interventions.
The WHO says that as the ebola outbreak continues to evolve, the three main affected countries -- Guinea, Liberia and Sierra Leone -- struggle to control the infection against a backdrop of severely compromised health systems, significant deficits in capacity and fear. WHO estimates that from six to nine months will be needed to control the outbreak and has released a ‘road map’ detailing what needs to be done to achieve this.
WHO earlier this year identified multiple vaccines and therapeutics in the development pipeline and concluded that it would be acceptable on both ethical and evidential grounds to move forward with conducting clinical trials for several of these products. Research has been conducted in vitro and in animal models, but not in humans. It was agreed that clinical trials should be designed to yield the fastest useable results combining simplicity with efficiency without harming communities, individuals and health providers.
However, the ethical aspects of study design in the context of an ongoing epidemic and the absence of a therapeutic option had not been explored. The WHO has says it is crucial that research studies going forwards in this particular context conform to international ethical norms and are scientifically robust.
The objectives of the Ethics Working Group’s meeting were to:
1. Conduct an ethical analysis of the available study design options (e.g. with respect to risks, benefits, equity, autonomy etc.)
2. Provide advice on the ethical considerations that are relevant for different study designs in the given context.
The group was able to reach consensus on some points and identified others that need further study and discussion.