Experts advise caution in drug trials

Stricter guidelines relating to clinical drug trials have been recommended by the expert group convened by the health secretary in the wake of the recent trials which left six men seriously ill.

The Expert Scientific Group (ESG)’s interim report, published today, outlines how the safety of drugs trials involving monoclonal antibodies can be improved to prevent the kind of reactions which the six men suffered following trials for German biotech firm TeGenero’s drug known as TGN1412 in March this year.

Its recommendations include giving the drug to one person in trials of this type and leaving sufficient time to see if adverse reactions appear before giving it to other people.

Such a procedure was not carried out in the trials at Northwick Park hospital in north-west London, when six men went on to suffer multiple organ failure.

Drugs which affect the immune system should be given to people who are already ill rather than healthy volunteers, the report added.

Better dialogue between the drug developer and regulator as well as international sharing of information is advised to ensure a more thorough understanding of safety data and serious adverse reactions.

It is also recommended that specialist centres are created to undertake phase one studies on higher risk trials.

Professor Gordon Duff, chairman of the ESG, 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.

“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.”

Health minister Andy Burnham welcomed “the great deal of progress already made” and said that a public consultation will take place on the proposals, allowing further opportunities for interested parties to provide evidence.

A further report to parliament is expected in the autumn once the ESG has completed its work.

Privately-owned TeGenero filed for insolvency earlier this month, saying the publicity surrounding the phase one study made it impossible for it to attract investment to keep operating.

© Adfero Ltd