Ethics of randomized trials in a public health emergency

Résumé

The 2014-2015 outbreak of Ebola in West Africa claimed over 11,000 lives and laid bare the challenges of responding to a large-scale, swiftly evolving public health emergency.Prominent among these difficulties was disagreement about the ethics of conducting clinical research during epidemics and whether clinical trials of vaccines and therapeutics should employ randomization and concurrent controls.To facilitate rapid, well-coordinated responses to future public health emergencies, the United States National Academies of Sciences, Engineering, and Medicine established a committee to assess the clinical trials conducted in Guinea, Sierra Leone, and Liberia during the outbreak.The key findings and conclusions regarding ethical issues raised about conducting research during public health crises are briefly described here and are fully evaluated in the Committee's report [1].First, the Committee concluded that "research is an essential component in epidemic response, as it is the only way to learn how to improve care for current and future patients and to potentially prevent an epidemic from occurring again" [1].For diseases like Ebola, outbreaks provide the only setting in which clinical trials can be conducted to determine efficacy and safety of investigational products for treating or preventing infection, because results from animal models cannot be reliably extrapolated to humans, [2] and human challenge studies are not possible.Although some clinicians perceived conflict between their clinical obligations and the mission of research, conducting clinical trials during outbreaks is indispensable to determining which interventions actually advance the humanitarian mission of minimizing mortality and morbidity.Second, to learn how to improve care, research must be designed to generate evidence that can support reliable inferences about safety and efficacy.The Committee concluded that "randomized controlled trials (RCTs) are the most reliable way to identify the relative benefits and risks of investigational products, and, except [in] rare circumstances. . .every effort should be made to implement them during epidemics" [1].Third, the committee rejected the claim made by some stakeholders that due to Ebola's high mortality rate, equipoise would not exist for studies of therapeutic interventions that included the possibility of randomization to a standard-of-care control arm [3].In part, such claims reflect the mistaken idea that equipoise refers to a state of uncertainty in the mind of the individual researcher, in which each intervention is equally likely to be superior to the others.Thirty years ago, Freedman rejected this view because it would prohibit studies in situations in which researchers have a hunch that one intervention is superior to the others but in which the information on which that hunch is based is not sufficient to persuade other reasonable experts [4].Similarly, it would prohibit research in cases where fully informed experts have conflicting judgments about

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