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Monday 22nd January 2018

New drug trial standards

24th July 2006

30032006_GreenCell1.jpgA report by the Association of the British Pharmaceutical Industry and the BioIndustry Association concludes that human testing of experimental drugs to stimulate the immune system should be subject to special new safety standards. 

The industry guidelines have been triggered after six volunteers fell ill after being injected with TGN1412, an experimental rheumatoid arthritis drug.

The guidelines drawn up by the industry's two largest trade associations, suggest that trial dosing for monoclonal antibodies that are "agonists", such as TGN1412 should take into account not simply its toxicity based on animals, but also the drug's biological effects.

According to a panel set up by the two bodies test doses should also be staggered, with only one person receiving the drug for the first 24 hours and then dosing increased slowly thereafter in others.

The industry taskforce established by the ABPI and BIA said there was a need for new mechanisms to share information on safety issues for drug testing.

The co-chairman of the panel, David Chiswell, said that existing procedures for the most clinical trials had proved extremely safe, but new safeguards would prove valuable for the small number of biological drugs under development called agonists.

The report stressed that clinical studies should be conducted in a hospital that has intensive care facilities on hand in the event of problems. Suitable training should be given to staff, with particular emphasis to manufacturing controls to ensure safety, quality and efficacy of the trial drug.

Parexel, the US company that conducted the trial at Northwick Park hospital in north-west London, was criticised for minor procedural errors by the MHRA, the UK medicines regulator.

A report into the trial commissioned by the government from Professor Gordon Duff, an expert in molecular medicine at Sheffield University is imminent. Industry executives and trade associations attended a question and answer session and submitted their recommendations but were excluded from Prof Duff's commission.

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