What is electronic data capture (EDC) in the end? Does it simply transfer the inefficiencies of paper case report forms to the internet? Or will EDC facilitate organization-wide efficiencies or even scientific discovery?

Many companies in the life sciences are wrestling with whether to rebuild their systems and processes around EDC. For some sponsors of clinical trials, just using EDC can be a mammoth labor with few hard, quantifiable savings in cost or time.

Wyeth is the rare big pharma to be speaking clearly and boldly on what EDC could make possible. At a time when some longtime users of EDC mumble about their experiences, Wyeth sees it as central to its future efficiency and integral to the agile management of trials.

Wyeth’s Jane Clarke made that clear in a recent presentation at the IIR Clinical Technologies Conference in Philadelphia late in October. Clarke is senior director, clinical development operations support; she’s also EDC system owner.

Raising Hopes

Clarke has been at Wyeth for eleven years, and in the industry for nearly twice as long. And she expressed her own frustration at the industry’s declining productivity. “It’s taking us longer to get those products to market,” she says. “I signed up to get those products to market as quickly as I could, in my own little way.”

Clarke believes that technology in clinical trials will help the industry be more productive. “I’ve been excited to see the e-technology come into our business,” she says. “It’s going to help us get those products into the market more quickly.”

EDC Evangelist

At Wyeth, as best we can tell, EDC is considered a keystone technology to support other improvements in process and data management. “EDC is not going away,” Clarke says. “I told you how evangelical I am about it.” Wyeth is now using EDC on the majority of its trials.

Clarke and Wyeth predict the industry’s usage of EDC can be divided into three stages. The first simply involves getting up and going with EDC. In the second, business efficiencies appear. The third stage, for Clarke, is when EDC is fully integrated not just with other systems for research in industry, but also with more generic systems in physician offices and hospitals. Says Clarke: “That’s to me the ultimate end game. Electronic medical records and telemedicine. That’s where we need to get to.”

Second Stage

Where is Wyeth now? Somewhere in the second stage, having reduced the time from the last patient visit to database lock from as much as 209 days to 25. In just eleven months of using EDC, Clarke noted, the company ramped up from 9 percent of trials using the technology to 97 percent.

At this point, to be excused from using EDC at Wyeth, you need a waiver signed by the head of research. Good luck with that. “You have to have a very good reason not to use EDC,” Clarke notes. “We take no prisoners.”

In the middle of her talk, she noted that New York City EDC firm Medidata Solutions would be handling Wyeth’s EDC needs. The technology side of that story can be read here. Clarke did not dwell on the role of its EDC vendor in any detail because an executive from the company was slated to speak at the same event later in the day.

Adaptive Push

As Clarke explained, the changes at Wyeth are being necessitated by a surge in productivity in the discovery and preclinical phases of the research process at Wyeth. (She called the coming number of projects a “tsunami.”) It’s hardly a surprise that there will not be more people to pull the sled.

To handle the work, Wyeth’s “Project Springboard” was conceived to expedite the clinical process and technology map. Adaptive trials are part of the company’s future, she says. “If you’re not using EDC, you can’t do adaptive trial design,” says Clarke.

Data For ‘Free’

One of the most illuminating notions of the presentation was “data for free.” It means that if data are in a system, they should not have to be re-entered. “If a piece of data exists, I want it populating all the systems we use, so we are not duplicating effort and causing error,” says Clarke.

Clarke related that her frequent flier miles had allowed her to arrange a private tour of the British Airways IT department. She was impressed that in real time, a passenger checking in for a flight instantly triggers data moving to other systems calculating the necessary food, fuel and other variables of the flight. Clarke seems to wish that the transactional systems of other industries could be emulated: “Why can’t we use the technologies and concepts they use? There is data for free there, moving across all their systems. That is the concept I have for our system.”

Patient Reported Outcomes

EDC is also a central component of Wyeth’s two-step “Learn, Confirm” model, which compresses the traditional four phases of clinical trials to a more iterative process.

In one of her most tantalizing remarks, Clarke implied that Wyeth is well along the way to persuading the FDA that the “Learn, Confirm” concept is a viable one. “We are working with FDA to get them to accept this process,” she said. “They’ve commended us on coming up with the shift in concept.”

The company is also an especially heavy user of electronic patient reported outcomes (ePRO). By Clarke’s estimation, perhaps two thirds of the company’s trials have some data that is directly contributed by patients. That data, too, will be tied together in the third stage of its EDC adoption.

CTMS Integration

Wyeth is using the Impact clinical trial management system (CTMS) from Perceptive Informatics. It’s not clear how intimately connected the EDC and CTMS applications are at Wyeth, but that is a long-term goal. Wyeth has scaled back on the number of people using the CTMS system to thirty, reducing the training costs when a new version of the program is installed. 

Down the road, Clarke would also like some sort of system to have more operational documents. She noted that the European trial directive will require organizational charts and training records to be a part of any submission dossier. If such documents are not included or accessible during audits, she predicts, some submissions could well be rejected. “We’ve got to start looking at the administrative database proving we’ve complied with regulation,” Clarke said.