Paul Clarkson is director of clinical data management at Genentech and served as co-chair of the planning committee for the recent Society for Clinical Data Management (SCDM) meeting in Chicago. The blossoming of trial technology and the challenge of managing it, he says, have been good for the SCDM membership roster and conference attendance.

“It’s our biggest ever. The meeting has taken off,” says Clarkson. “The society has taken off.” There were more than 750 people at the 2007 gathering in Chicago, roughly a third of the SCDM membership, with a new influx of attendees from outside the U.S.

EDC Leads To Growth

To some, electronic data capture (EDC) may be familiar, old hat. But it remains fresh to SCDM members. Says Clarkson: “EDC adoption is becoming a reality for a lot of companies very, very quickly. We have people coming here seeking networking and guidance.”

Clarkson says that with EDC in the mix, the role of the data manager is shifting. “It was, to a certain extent, a glorified clerical position,” he says. “That all goes away. There is more emphasis on project management—that was always there.”

New Role

In some respects, he says, the conference showcases the higher profiles that data managers are carving out as they manage vendor selection, vendor audits, user acceptance testing and other cross-functional tasks that involve more than just locking databases. “It gets a lot of visibility,” Clarkson says of the broader portfolio of the 21st century data manager.

It may also require a new psychological profile, he muses: “People who are attracted to do data management by nature are not self-promoting and would prefer not to be in the limelight.” That may have to change.

Right Metrics?

Clarkson was standing next to Anthony Costello, a Nextrials executive who chairs the SCDM board of trustees. “As EDC settles in, data management departments are finding themselves at the center of those activities,” Costello says. At the same time, familiarity with EDC is letting other colleagues not bother data managers as much. “Other functional areas are becoming more data savvy. Now you can go run your own ad hoc report on the EDC system,” Costello adds.

The evolution of the role of data managers was evident in most of the presentations at the conference. Stephanie Alfano, manager of global data management at Schering Plough Research Institute is an example. She wondered whether the right metrics are being monitored. “We really need to take a look at the metrics we capture. They don’t always transfer easily from paper to EDC.” She cited a report that Schering runs to identify sites that have not been entering their data, triangulating between lab data and visit data. 

Let ‘em Complain

Martha Johnson, data manager at the contract research organization PharmaNet, said that on a difficult project, the maintenance of morale can be an issue. She let her team members vent. Says Johson: “This contributed a great deal to morale. Motivating our in-house clinical data management team was difficult. We’d laugh. A lot of dark humor, just so we could get through the study.”

Lilly’s Mike Lozano, associate clinical data management consultant, gave a surprisingly philosophical presentation. “Why is it we’re getting information in this way on this trial, but in another trial we get it in a completely different way?” he asked rhetorically. The question had no obvious answer. But our sense from the conference was that data managers are starting to venture into optimizing trial design, and using their understanding of the operational difficulties of a design to tweak it before problems arise.

Evolving Processes

“Technology is never the solution,” Lozano went on to say. “It’s a means to an end. Without the proper process and planning changes, we will never realize the benefits. In fact, in some cases, [technology] might go the other way and make things worse.”

Every data manager, he said, will have to evaluate whether there is a good fit between a new tool and an old process—or a forced fit. “We are the hub of information about the EDC system,” he said of his fellow data managers. “We are becoming the subject matter experts. We need to step up to the plate and be experts on new processes and technology. We need to be leaders in establishing standard processes.”

Editor’s note: We’ve been doing our best to exhaust our notes from an interesting meeting. This news roundup covered a few different presentations. Not every trial unfolds without a hitch, as this story illustrates.  EDC vendor DSG won the show’s main award. We also covered new tools from Nextrials.