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