Savings from Electronic Data Capture Not Yet Proven

Planners should anticipate that electronic data capture (EDC) may cost money to implement, at least at first, and should be prepared to deal with other obstacles in the adoption process, according to one expert.

“The cost savings [of EDC] are not proven,” Valerie Paolella, clinical research manager for Cato Research Canada, told attendees at the Association for Clinical Research Professionals (ACRP) in Phoenix. For starters, smaller and early-stage trials may not save any time and may even lose money with EDC, she warned. That’s because EDC’s relatively high start-up costs don’t vary much based on trial size or stage. “The economies of scale” aren’t there for small or Phase I trials, she suggested.

And EDC’s start-up time is longer for most sites compared to paper, she added. One big reason: Designing, programming, testing data entry screens and edit checks must be done in advance with EDC before the first subject begins the program. With paper, those tasks can be done over several months as subjects enter the trial.

Check the Vendors

Sponsors exploring EDC should leverage the experience base of their sites, she advised. For example, they should ask sites about their experiences with EDC and how they have dealt with set-up and firewall issues. It can also be useful to talk with sites about electronic case report form (eCRF) connectivity history, she added.

Some vendors offer a live connectivity test, and that’s something a sponsor should definitely push for, Paolella said. Try to arrange that test while you are doing a site evaluation, she added.

However, EDC is also somewhat hampered because there are relatively few dominant, mature vendors serving the market, Paolella said, echoing concerns raised by many ACRP conference attendees. That makes it all the more important to bring in different disciplines from your company when vetting a vendor, she said. For example, data managers and statisticians can often come up with some good questions to help you size up a vendor.

With EDC, different phases of trials require different skills. A vendor who was good at one skill will not necessarily be strong in another area, she warned. “Previous experience with a specific EDC vendor is not necessarily an indication of their [other] capabilities,” she stressed.

EDC may sometimes be less efficient than paper when it comes to managing the query process, Paolella said. A helpful tip: If your trial has a prepopulated laboratory dataset, it may require conversion prior to data entry. That upfront conversion can “save a lot of query time later,” she said.

Proven Benefits

Upper management has shown some reluctance regarding EDC, she warned. For example, some leaders insist on collecting paper signatures in addition to signatures. This is unnecessary and time-consuming.

But EDC does have proven benefits. “One of the big advantages of EDC” versus paper is that it provides timely access and faster notification about adverse events, deviations and study endpoints, Paolella said. EDC also eliminates double data entry and frees up a lot of physical storage space.

But EDC training must be ongoing and documented. That means stressing to sites that once the trial begins “the data being entered is real,” Paolella said. She advised setting up a mock online eCRF to allow data entry personnel to practice with the electronic form. It can help users to better understand how the system works, she said. For example, real testing prepares users for issues such as when option boxes disappear when data is entered. — Michael Causey