With the adoption of any new technology—from coal to lasers—lofty expectations are slowly eroded by the day-to-day reality of the technology in actual use. In the clinical trial landscape, the tool of the hour is electronic data capture (EDC). Is it helping? Is it making a difference?
Jason Ridderikhoff, regional operations manager for Eli Lilly in Canada, spoke to that at Insight Information’s “eClinical Trials In Canada” conference, held in Montreal at the end of March and beginning of April. Ridderikhoff helped set the company’s global strategy for data monitoring, which the EDC vendor community has long advanced as an area that could be transformed by its technology.
Notably, Ridderikhoff said that the firm has seen a 70-80 percent reduction in queries. More than half of all queries are resolved on their own. “We’ve seen the character and nature of our queries change,” he reports. The huge promise of EDC, of course, was that some minor errors would be caught automatically and not require much human intervention. That seems to have occurred, and to be a welcome development, even on the most complex studies. “Our oncology sites love the system we’re currently using,” Ridderikhoff says.
Has EDC reduced the need for travel on the part of monitors? Saved money? “Likely not,” Ridderikhoff said. “We do need to manage senior management expectations of what EDC can actually do.” This does not mean the company is unhappy with its investment, just that it continues to expand what people should be doing in light of what the computer can handle.
At Lilly, Ridderikhoff says, monitors who formerly spent 70 percent of their time at sites are now spending about half of their time out of the office. It appears that the amount of source document verification is adjudicated on a trial by trial basis, but has dropped 50 percent already, and in some cases may be applied to as low as 20 percent of the data.
There’s more good news. The frequency of visits to sites can indeed be reduced. “We have switched to site visits on an as-needed basis,” he said, not quarterly or at some fixed milestone.
The ability to remotely inspect the available data allows better decisions about when to visit a site. The technology, Ridderikhoff suggested, could help monitors be less annoying to sites during visits when they do visit. “Don’t take a long time with your sites,” he says. “It becomes a huge source of frustration.” Access to the EDC system while visiting the site can be a challenge for monitors, Ridderikhoff said, and may be just 60 or 90 minutes.
In the final analysis, a more nuanced role for monitors is taking shape, with a bit more telephone and remote interaction, and a bit less of just fixing individual queries. “We have asked our monitors to shift their activities,” he says. “These have not been easy. Our monitors still like that in-person, face-to-face visit. Monitors need to be shifting their focus away from mundane activity to high-value aspects of an onsite visit.”
Some examples of “high-value” activity at the site include patient safety issues, readiness for audit and protocol adherence. Says Ridderikhoff: “Our monitors are typically highly paid employees. We need to get value out of them.”d9A2t49mkex