Tag: phase 1 clinical trials
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.”
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.
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.