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| home > epc > winter 2002 > clinical trials: loss prevention is better than cure |
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European Pharmaceutical Contractor
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According to Center Watch, a patient information group which monitors clinical research, of every 1,000 research subjects who take part in clinical trials, 300 will not understand that the study could carry additional risks and discomforts, whilst 700 do not know what questions to ask at the outset. Put another way, 30 per cent of people involved in a clinical trial could take legal action against the sponsor or manager.
Isolated incidents of death resulting from clinical trials (Jesse Gelsinger in 1999 and Ellen Roche in 2001, both in the US) have increased public scrutiny. Today, clinical trials are under fire to the extent that the life sciences industry faces a relatively new threat - litigation. Lawsuits are expected to increase for a number of reasons, including heightened media attention, the vast number of products being tested and some vulnerability in the trials system itself. The good news is that careful risk management can minimise the potential for litigation. And if the worst should happen, comprehensive insurance protection can lessen the impact.
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