A large government trial comparing treatments for a life-threatening condition called sepsis is putting participants at risk of organ failure and even death, critics charge, and should be immediately shut down.
A detailed analysis of the trial design prepared by senior investigators at the National Institutes of Health Clinical Center in Bethesda, Md., concluded that the study "places seriously ill patients at risk without the possibility of gaining information that can provide benefits either to the subjects or to future patients."
In a letter to the federal Office for Human Research Protection, representatives of Public Citizen's Health Research Group compared the study, called Clovers, to "an experiment that would be conducted on laboratory animals."
"The human subjects of the Clovers trial, as designed and currently conducted, are unwitting guinea pigs in a physiology experiment," Dr. Michael Carome and Dr. Sidney M. Wolfe wrote in their letter.
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https://www.nytimes.com/2018/09/24/health/sepsis-trial-treatments.html
