The European Medicine Agency has floated draft guidelines on the testing of potentially high-risk medicines in people following the disastrous TGN1412 trials.
The guidelines, which will be open for comment for two months, hope to reduce the risk of experimental medicines to clinical trial volunteers. It provides information on moving from animal tests to human as well calculating the first doses that human subjects should receive and how to manage dose escalation.
The TGN1412 monoclonal antibody trial in March 2006 caused an extreme adverse reaction in six volunteers at Northwick Park Hospital in London (C&I 2006, 7, 8; 21, 9).
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