Trial design, exclusion criteria, vulnerable groups seen causing trial suits.(Litigation)

PHILADELPHIA -- Emerging theories aside, there are three primary areas currently fueling clinical trials litigation--design of clinical trials, exclusionary criteria used to recruit subjects and the handling of vulnerable populations, defense attorneys told a Center for Business Intelligence (CBI) meeting here Dec. 4-5.

These issues touch sponsors, IRBs, CROs and investigators in varying ways, and each of these entities bears varying responsibility depending upon the particular circumstances and nature of the suit, said Frederick Rom, partner with Womble Carlyle Sandridge & Rice PLLC, in Research Triangle Park, NC.

Rom discussed several emerging legal theories that are "coming out of nowhere." They are broad, catchall concepts that, while not yet been established in the courts, are gaining some traction. One is the concept of fiduciary responsibility, which says the defendant "has a special relationship with the plaintiff and has an affirmative duty, an obligation, to act in their best interests," Rom said.

"There is a disconnect in the public's perception of clinical trials, in that they are seen as valuable to human health, but they are being handled improperly," Rom …