Clinical trial liability
The compulsory cover of a trial sponsor, whose regime is no-fault and whose loss experience is rare, abrupt and concentrated on one protocol.
On March 13, 2006, at Northwick Park Hospital in London, six healthy volunteers received TGN1412 in a first-in-human trial and ended up in intensive care. In January 2016, in Rennes, the BIA 10-2474 trial left one volunteer dead and several with neurological injuries. Both accidents led to tighter dose escalation and staggered monitoring between volunteers. They also show the shape of the line. A trial exposes people to a product whose effects are unknown; that is what a trial is. European regimes draw the consequence. The sponsor must carry insurance, and it answers for harm without the claimant having to prove fault, once the link with the research is established. Losses are very rare, which keeps premiums modest against the limits, and heavily concentrated when they hit, since one protocol gives the same substance to several volunteers on the same day. Then comes attribution. Separating the product's effect from the progression of the disease under study is simple in a healthy volunteer and far harder in a patient.
On March 13, 2006, at Northwick Park Hospital in London, the first-in-human trial of TGN1412 sent six healthy volunteers to intensive care. In January 2016, in Rennes, the BIA 10-2474 trial caused the death of one volunteer and neurological injury in several others.
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