Injury to Research Volunteers — The Clinical-Research Nightmare

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Abstract
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 T lymphocytes. It was hoped that this product would benefit patients with B-cell chronic lymphocytic leukemia or autoimmune diseases such as multiple sclerosis or rheumatoid arthritis. Preclinical testing, including tests in rabbits and monkeys that used doses up to 500 times as high as the doses received by the first group of volunteers,1 reportedly showed no signs of toxicity.

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