Safety first?

摘要

The Royal Statistical Society working party on medical studies on human volunteers made its report on March 13th this year, a year to the day after the disastrous TGN1412 trial left six volunteers gravely ill. Stephen Senn, who chaired the working party, reflects. On March 13th, 2006, eight healthy volunteers entered a placebo-controlled trial of the biotechnology company TeGenero's monoclonal antibody, TGN1412. The treatment had never been tested in humans before; this was what is sometimes called a "first-in-man" study. The first subject was given his intravenous injection at 08:00. Injections followed at 10-minute intervals. By midnight of that day all six of the eight volunteers who had been given the active treatment had been admitted to intensive care at nearby Northwick Park hospital with symptoms of a severe immune reaction. They had suffered what is sometimes referred to as a cytokine storm.