Lessons From a Failed Drug Trial

摘要

Doctors who treated the six young men who became desperately ill in a botched U.K. clinical trial last spring have released an in-depth record of the catastrophe. They confirm, for example, that the volunteers were given intravenous doses of a test drug in quick succession (10 minutes apart), even though the drug had never been given to humans before. The subjects began to show signs of illness within 50 to 90 minutes, according to the report. And within 12 to 16 hours, all six were transferred from a company research site, which couldn't handle the emergency, to the Northwick Park and St. Mark's Hospital in London, which rescued them. The men appear to have recovered. But even 30 days after the test, according to a paper released this week from the 7 September New England Journal of Medicine (NEJM), some had "short-term difficulties in finding words (particularly names)."