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Drug Trials

Volume 447: debated on Tuesday 20 June 2006

To ask the Secretary of State for Health if she will take steps to ensure that in human trials of medicinal drugs not previously ingested by human beings the drugs are not to be ingested simultaneously by the volunteers. (76616)

Following the recent drug trial incident involving TGN 1412, an expert working group of leading international experts was established to address the scientific questions that were raised by it. In particular, recommendations we requested regarding this type of drug and how to manage the risks associated with making the transition from pre-clinical testing in animals to trials in humans.

Professor Gordon Duff, who is Professor of Molecular Medicine at Sheffield University, has been appointed to act as chair of the group.

On receipt of the report from this group, the Government will consider what steps might be required to minimise risk for first human trials in the light of their recommendations.