Injury to Research Volunteers — The Clinical-Research Nightmare

Interview with Alastair Wood on the recent disastrous outcome of a phase 1 clinical trial of a monoclonal antibody in England. (06:42)Download At 8 a.m. on Monday, March 13, 2006, eight healthy young men entered a trial of a drug under development by the small German immunotherapeutics company TeGenero. Six of the volunteers were assigned to receive active drug, and two were to receive placebo. The trial was being conducted for TeGenero by Parexel, a large contract research organization, at its facility at Northwick Park Hospital outside London. The six volunteers were to be the first humans to receive TGN1412, a humanized monoclonal antibody designed as an agonist of the CD28 receptor on T lymphocytes, which stimulates the production and activation of . . .