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Drug trials under scrutiny

12th December 2006

18032006_NorthwickPk1.jpgThe group established to make recommendations on improving the safety of drug trials has published its suggestions.

In the wake of the botched drug trial in March which nearly killed 6 people, the independent Expert Scientific Group (ESG) was asked by the Secretary of State for Health to examine trials involving new types of drugs. The ESG made 22 recommendations which will have far-reaching implications for those involved in the conduct and safety of first-in-man clinical trials.

The recommendations cover a number of key areas including; the need for scientific advice from independent experts before trials of high risk substances are approved; information about unpublished clinical trials and adverse reactions occurring in trials; the conduct and environment of clinical trials; the clinical trial application process; the skills and future specialist training needs of those conducting clinical trials and the location of trial units and the provision of adequate medical back up in case of problems arising. The experts have also advised that some drugs are best given to people who are already ill and has suggested that a group be set up to advise the government’s drug regulatory body.

However the victims of the catastrophic trial at Northwick Park Hospital in London, expressed disappointment that the enquiry didn’t point the finger of blame at anyone. They have called the report the latest in a “series of whitewashes?. The trial, undertaken by the volunteers last March, involved an experimental drug called TGN 1412 which was designed to treat multiple sclerosis, leukaemia and arthritis. Its makers, German biotech company TeGenero, thought it would subtly "re-tune" the immune system but instead it sent the immune systems of the six men into overdrive causing multiple organ failure. The worst affected, Ryan Wilson, had to have his fingers and toes amputated. The trial victims are launching a multi-million pound damages claim against Parexel, the research company that conducted the trial.

The expert scientific group, led by Professor Gordon Duff, said it took into account the events at Northwick Park when making its recommendations. But the solicitor representing the victims said, “This report has done a good job at looking at the lessons to be learnt but it does nothing in terms of helping my clients understand the details of exactly what happened and what went wrong."

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