Ethics of randomized trials in a public health emergency

• Published in: PLoS neglected tropical diseases Vol. 12; no. 5; p. e0006313
• Main Authors: London, Alex John, Omotade, Olayemi O, Mello, Michelle M, Keusch, Gerald T
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 17.05.2018; Public Library of Science (PLoS)
• Subjects: Clinical trials; Committees; Community; Demographic aspects; Ebola hemorrhagic fever; Ebola virus; Ebolavirus; Engineering and Technology; Epidemics; Ethical aspects; Ethics; Infectious diseases; Intervention; Management; Medical research; Medicine; Medicine and Health Sciences; Mortality; People and Places; Public health; Research and Analysis Methods; Risk factors; Studies; Tropical diseases; Vaccines; Viewpoints; United States; United States > US; Europe; West Africa
• ISSN: 1935-2735; 1935-2727; 1935-2735
• DOI: 10.1371/journal.pntd.0006313

Funding: The study on which this Perspectives article is based was supported by a grant from the US Department of Health and Human Services, The Food and Drug Administration, and the National Institute of Allergy and Infectious Diseases to the National Academy of Medicine. [...]to learn how to improve care, research must be designed to generate evidence that can support reliable inferences about safety and efficacy. [...]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]. [...]to frontline caregivers facing overwhelming clinical need and acute shortages of supplies and manpower in the early stages of the outbreak, research felt like an unjustifiable diversion of scarce resources.