As you read this there are probably as many as 100,000 people taking part in clinical trials in 165 countries around the world. Such trials, involving pharmaceuticals or medical devices, can last for years and are necessary if products are to be used safely to treat illnesses or alleviate medical conditions.
While clinical trials are almost always completed without incident, thanks to the strict controls in place, a major incident sometimes grabs the headlines. In 2006, for example, six men became critically ill with multiple organ failure while taking part in the trial of a drug dubbed TGN1412, intended by its maker TeGenero for use in treating rheumatoid arthritis and leukaemia.
The drug had been developed in line with all regulatory and clinical guidelines, and had been shown to be safe in earlier non-human studies.
Compensation protection
Not surprisingly, pharmaceutical manufacturers and companies that conduct clinical trials all need to purchase insurance to cover themselves against the risk of a study going wrong and being subject to massive compensation payouts.
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