Tag: phase 1 clinical trials
“More on the Clinical Trial Disaster in France”
Just last week one person was declared brain dead and five more were hospitalized after taking a psychiatric drug in a clinical trial. Writing for Science, Martin Enserink provides more information about the drug as new details emerge.
“6 Hospitalized, One of Them Brain-Dead, After Drug Trial in France”
Six men were hospitalized and one was pronounced brain dead after participating in a phase 1 clinical drug for a mood, anxiety, and motor dysfunction drug manufactured by Bial and administered by Biotrial. Carl Elliott, a bioethicist at the University of Minnesota, said investigators should look into questions like how much the men were paid and whether they properly consented to the trial. “Many Phase 1 trial volunteers are poor and unemployed, and they volunteer for trials like this because they are desperate for money,” he said. “This means they are easily exploited.”
“Martyrs to Science? When Research Participants Die”
Neuroskeptic covers a short article by Susan Lederer that appeared in the American Medical Association Journal of Ethics discussing what happens when research participants die.
“Medical Research: The Dangers to the Human Subjects”
Marcia Angell in the New York Review of Books writes about the inherent conflict in clinical trials between “the search for scientific answers," on one hand, and “the rights and welfare of human subjects,” on the other.