Experts Discuss How Device Trials Should Handle Adverse Events

Sites running clinical trials for devices should document all adverse events and investigators’ responses even if they don’t ultimately report the events to regulators or Institutional Review Boards, a contract research organization executive told the MAGI clinical research conference in San Diego last week.

Drug trials must report all adverse events but device trials have a little more leeway. Still, in the old researchers’ saying, “If it’s not documented it’s not done,” said Rachel Silver-Kessler, director of clinical support services at IMARC Research, a Cleveland-based CRO.

She suggests that research coordinators track any adverse events that come up during a device trial and build a database around simple “yes/no” propositions, such as “was the event serious?” or “was it associated with the device?”

Silver-Kessler shared the stage with Kenneth Kleinhenz, the vice president for regulatory affairs for CSSi Lifesciences, a Baltimore-based CRO. Once a device is approved for market, there are still federal reporting requirements for adverse events. Two of those — death or malfunction — are fairly straightforward. But requirements to report any adverse event that causes “serious injury” can often trip up device sponsors, Kleinhenz said.

A good rule of thumb is to report any event that requires any kind of medical intervention — something as seemingly banal as a dose of antibiotics, Kleinhenz said. Some device companies try to litigate their way around the vagaries of reporting requirements — the definition of “permanent” damage, for instance — but “you’re going to lose that argument every time” when the FDA comes calling, he said. — Bill Myers