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In recent years, several clinical trials have not been successful and have had devastating effects upon the volunteers taking part. We heard just last month that one person had been left brain dead, and five others were hospitalised, after a clinical trial of a drug trial went wrong in France.
This isn’t the first case of this type: In 2006, six young men were treated for organ failure within hours of taking a trial of a drug to treat rheumatoid arthritis and leukaemia in London. The men were admitted to intensive care where some of their heads swelled up. The incident was thereafter nicknamed the “Elephant Man Trial”. Sadly, a number of the men lost fingers and toes and all were told that they would likely develop cancer and other serious diseases as a result of exposure to the drug.
Clinical trials are – of course – important as they take place before a new medicine is granted a licence. New products do have to be produced, but both healthy and patient volunteers need to be aware that they can become ill or be injured.
Before a trial can take place, the manufacturer must obtain clearance from the Medicines and Healthcare Products Regulatory Agency. All trials are regulated and there are strict guidelines that the manufacturers must follow.
If you are injured as a result of a trial, then there are no fault compensation guidelines. Both the Association of British Pharmaceutical Industries and the Association of British Healthcare Industries have issued no fault compensation guidelines. In fact, the first guidelines from ABPI were issued as long ago as 1970.
The guidelines suggest that the volunteers should be given a clear commitment that if they suffer bodily injury through participation in a trial, then appropriate compensation will be paid without them having to prove either that their injury arose through negligence, or that the product was defective.
They also state that the amount of compensation should be calculated by reference to the amount of damages commonly awarded for similar injuries by an English Court if liability is admitted.
This is a complex area so it is vital that you consider all the potential things that can go wrong before entering into a trial.
However, if you or a member of your family have suffered as a result of participating in a clinical trial then please do contact me.