The compulsory cover of a trial sponsor, whose regime is no-fault and whose loss experience is rare, abrupt and concentrated on one protocol.
Research involving human subjects exposes volunteers to a product whose effects are unknown, which is the very definition of a trial, and European regimes draw the consequence: the sponsor must take out insurance and answers for harm without the claimant having to prove fault, once the link with the research is established. This line's loss experience has a distinctive shape underwriting must take in. It is very rare, which makes the premium modest against the limits, and it is extremely concentrated when it occurs, since one protocol administers the same substance to several volunteers on the same day, so an accident is collective from the outset. A difficulty of attribution compounds it, separating the product's effect from the progression of the disease under study, which is straightforward in a healthy volunteer and very hard in a patient. The two European reference accidents, both in first-in-human administrations, led to tighter dose escalation and to staggered monitoring between volunteers.
The first-in-human trial of TGN1412, conducted on 13 March 2006 at Northwick Park Hospital in London, sent six healthy volunteers to intensive care. The trial of BIA 10-2474, conducted in Rennes in January 2016, caused the death of one volunteer and neurological injury in several others.
clinical trial liability, assurance d'essai clinique, recherche impliquant la personne humaine