Are first-in-man clinical trials safe?
France’s recent clinical trial disaster has renewed fears about the safety of first-in-man studies.
On 6 January this year, six healthy men gathered at a clinical trial centre in the north-west of France.
For 1900 euros ($3000) each, they had agreed to put their bodies on the line to test the safety of a new psychotropic drug, known simply as BIA 10-2474.
The light blue capsules in front of them had been shown to be safe in mice, rats, dogs and monkeys, as well as 84 healthy human volunteers who had been given doses ranging up to 100mg as single administrations