It's Standards Time - Pharmaceutical Executive


It's Standards Time
Pharma does EDC in clinical trials, but is anyone doing it right?

Pharmaceutical Executive

When Wyeth launched its "Learn and Confirm" program, a paradigm shift in how the company performs clinical research, electronic data capture became a natural part of that initiative. Most of Wyeth's new clinical trial initiatives are based on the premise that decisions can be made in real time as the investigators receive the results. "You can't make the changes that you need to make within adaptive trial design if you're not getting data in quickly," says Jane Clarke, senior director for clinical development operation support at Wyeth.

With a paper-based system, it could take Wyeth up to a month or two to recover data from the investigative site and transcribe it into a database. With its new EDC system, the investigator puts the data into the system, and it's available for review back at Wyeth within the time it takes for the system to refresh.

In the two years since full EDC rollout, Wyeth has increased EDC implementation in its clinical trials from 9 percent to 95 percent, which it is now consistently maintaining.

Wyeth didn't go the vendor route. Instead, it developed its own application, custom built for the company. "[When we launched the program], we were not implementing applications at the speed that our management wanted," Clarke says. "I know many companies that started using EDC and then lost their way. I even know some companies that had gone back to paper. I didn't want to do that to Wyeth."

So the company decided on a staged approach to implementation. Stage one was intended mostly to get everyone comfortable with using the system as a standard of practice. The second and current stages were aimed to ensure that Wyeth has the most effective business processes and the most effective tools.

Remote Control

Most major pharmas are still struggling to support the staffs at remote research sites. The big question is: How do you get your investigators as comfortable with EDC as they were with paper?

One thing is certain: It will take time. BMS, for example, has been electronically capturing data on all new trials for the better part of five years. But because trials are long and new projects relatively scarce even in the best of times, only about 35 percent of BMS's current trials use EDC, and fewer than half of the protocol managers had ever touched one, explains Olsen. So while, on the one hand, the company says it has fully implemented EDC, key roles in the organization have yet to work on an EDC study or are still working on their first one.

"For big clinical trials, there's a long planning period from the time a trial goes through protocol concept to the time it gets to the first patient," Olsen says. "If we kicked off a study today, we realistically aren't going to get to the first patient until sometime next year. As we're ramping up and moving from pilot stage to 25 percent EDC, to 50 percent EDC, we have to remember that we still have a lot of studies that are legacy paper systems.

"One of my learning specialists said to me, 'If you think about adult learning behaviors, it's see one, do one, teach one,'" Olsen says. "If you take that concept that you've got to run something three times before you're really comfortable with it, it may be six to nine years before you're really as comfortable with EDC as you were with paper clinical trials."

Even with the long learning curve, Olsen says his teams truly appreciate EDC. Benefits include ready access to data, and real-time data cleanup as the studies move along. Because of automated query systems that are built into EDC technologies, the company is seeing a tremendous reduction in the number of queries and discrepancies that must be handled internally.

"Will we get to glossy, high-level ROI numbers in the immediate future?" Olsen asks. "Probably not. Will we see them in four or five years? Definitely yes."


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