The events at Northwick Park hospital involving six men being taken ill during trials of a new medicine on healthy volunteers are without precedent in many years.

 

​Hundreds of young, healthy volunteers who participate in early stage clinical trials every year are the pioneers of new medicines that have the potential to benefit millions of patients.

All such trials in the UK are subject to rigorous, independent ethical and scientific approval. All pharmaceutical industry trials in the UK have to receive prior approval from independent ethics committees and by the Government's regulatory body, the MHRA. All aspects of trials are closely monitored.

One of the most important rules covering clinical trials stresses that volunteers must give their informed consent based on appropriate details about the trial. Great care and precautions must be taken before experiments on volunteers start to ensure that they are medically and physically suitable against predetermined criteria.

Severe adverse reactions among healthy volunteers are extremely rare. largely thanks to detailed pre-clinical studies involving animals to help identity unwanted effects of potential new medicines. In this way hundreds of compounds tested within the laboratory and on animals each year never reach the stage of human trials because such unacceptable side-effects have been identified very early on.

For further information, please contact: ABPI Press office: 020 7747 1410

 

 
 
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