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Friday, 19 April 2024

Wednesday, 26 July 2006 09:17

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Rethink on human drug trials

According to a committee set up in the aftermath of the drug trial at Northwick Park Hospital which left six men seriously ill, say that the rules governing initial drug safety trials on human guinea pigs should be changed

The Expert Scientific Group was asked by the health secretary, Patricia Hewitt, to review what lessons could be learned from the trial. Three recommendations put forward by the authors are that doctors should consider using ill patients as test subjects rather than healthy volunteers; subjects should be given the experimental drug sequentially, rather than all at once; and doctors should be more conservative about the dose given to the first human subjects.

The Expert Scientific Group, led by Professor Gordon Duff said its recommendations applied to trials involving drugs such as monoclonal antibodies - of which TBN 1412 is one.

Professor Duff said: "Clinical trials in general have an excellent safety record, but in the light of the TGN 1412 incident there is a need to look at the future safety of clinical trials involving novel and potentially higher risk drugs

"Our interim report provides proposals for the future authorisation of trials involving these types of products and to further improve safety.

"Clearly the Northwick Park incident has informed the work of the group but this is not a further investigation into the incident.

"It is about the wider issue of such clinical trials and about ways to ensure that this type of trial is safe and effective for the future”.