Randomized controlled trials in the West African Ebola virus outbreak

The Ebola virus outbreak in West Africa poses significant global health challenges. It marks the first time in history that the Ebola virus, a level four pathogen, has gained a foothold in a large population for a prolonged period of time. This Ebola virus outbreak has been particularly destructive as it emerged in the context of fractured, barely functioning health systems in societies slowly rebuilding after protracted and violent civil wars. High mortality rates, including the death of a large number of health care professionals, have led to further deterioration in the already poor health status of the affected communities. The economies of the affected nations have suffered. In sum, it is a true humanitarian disaster. In August of 2014, the World Health Organization (WHO) invoked the International Health Regulations and declared the outbreak a Public Health Emergency of International Concern. Shortly thereafter, in light of rapidly mounting case counts, a complete absence of effective therapy and evidence that clinical and public health countermeasures in place were inadequate to stem the tide of the epidemic, the WHO convened a group to answer the question of whether unregistered interventions should be fast tracked for potential use in the clinical management of Ebola virus. The committee decided unanimously to accelerate research, with the proviso that all efforts be made to evaluate these ‘‘in the best possible clinical studies that can be conducted under the circumstances of the epidemic in order to establish their safety and efficacy or to provide evidence to stop their use.’’ For many, the only path to achieving ‘‘interpretable data’’ is through the use of Randomized Controlled Trials (RCT). In the context of the Ebola virus outbreak, some commentators argue for both the moral and epistemic necessity of RCTs in the context of the evaluation of therapeutic agents. These claims are often accompanied by a familiar refrain that RCTs are the ‘‘gold standard’’ for evaluating therapeutic effectiveness. Others have argued that RCTs do not have the epistemic virtues claimed for them and that ethical considerations may make them less than ideal in this setting. In the financial marketplace, the gold standard has long been abandoned as a means to commensurate the value of currencies. In medicine, the time has come to abandon the practice of invoking the ‘‘gold standard’’ label as a defense of RCTs. The convention may serve a rhetorical purpose, but it does not serve in any way as an argument to justify the RCT as a methodology. There are good reasons to question the gold standard rhetoric, and explore the variety of ways in which sound inferences can be drawn in clinical research while addressing ethical concerns. In this article, we will not argue which single study design should be used above all others in the context of an Ebola virus outbreak; rather, we will argue for the kinds of scientific and philosophical considerations that must be brought to the fore.