Complicações graves, nos ensaios terapêuticos, afectam 1 em cada 300 participantes - BMJ
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.”
Muitos ensaios terapêuticos deixaram de se fazer nos EUA
Several forces are pushing trials elsewhere, the researchers noted: cost (a trial at a top medical center in India may cost less than one-tenth per patient what it would cost at a second-tier U.S. center); faster approval times; and less red tape.
"One reason the industry is going abroad is the fact that there are complicated regulations [in the U.S.] discouraging pharmaceutical companies, although the main driving force is cost," said Adil Shamoo, a biochemistry and bioethics professor at the University of Maryland at Baltimore and editor-in-chief of Accountability in Research.
But what happens to the rights of human subjects, and to the types of drugs being developed?