Evaluating novel therapies during the Ebola epidemic.

The Ebola hemorrhagic fever outbreak inWest Africa poses acute and novel challenges for health policy and researchethics. Facedwith anexceptionally virulent infectious agent, limited resources, and danger to health workers, local and international authorities struggle to deployprovenpublichealth techniques thatcan limit the spread of the disease.1 In themidst of the crisis, experimental interventions thathaveneverbeenevaluated in human trials have captured professional and public attention. The prospect of first-in-human use of these interventions during an uncontrolled epidemic raises at least4pressingethical questions. First, is therea role for “compassionate use” of agents in the absence of human safety, efficacy, or dosing data? Second, given the critical scarcity of these agents, which patients should receive priority access? Third,what trial designs should be used to study these agents? Fourth, how should efforts to evaluate experimental agents coexist with establishedclinical andpublichealth interventions to treat patients and tominimize spread? Two fundamental principles should guide responses to these questions. Decisionsmust aim to prevent the maximum number of deaths during the current outbreak. Equally important, policy makers must seek to optimize knowledge gained for use in confronting future Ebola epidemics.