Industry Slow to Reap Benefits of ‘Paperless’ Trials

Khady Ndour, Quality Monitor, Columbia University Medical Center

Khady Ndour, Quality Monitor, Columbia University Medical Center

Good old-fashioned human aversion to change has slowed adoption of electronic tools for clinical trials that could bring industry the long sought “paperless office,” according to a panel of industry experts.

A recent survey shows clinical trial site staff say electronic data – particularly electronic health records and electronic data capture – are among the most important factors for successful study management. Yet adoption still lags.

“I think we’re still surprised that we’re not [more] advanced yet,” says Khady Ndour, a quality monitor at Columbia University Medical Center who will co-present “Going Paperless: A Smart Way to Increase Site Efficiency and Save Resources” at the ACRP 2017 Meeting & Expo. The industry is lagging for several reasons, but Ndour cited the U.S. Food and Drug Administration (FDA) as one indirect culprit. Many clinical trial practitioners believe FDA still wants to see certain documents in paper form, and it is not always clear what the agency’s expectations are, Ndour notes, saying, “We always wait for the FDA to take charge.”

Aversion to change is also an obstacle, panelists say. Many professionals are “kind of set in their ways,” says Wanda Truong, a clinical trials administrator at Weill Cornell Medicine Comprehensive Weight Control Center in New York City. It’s important for clinical research coordinators to lead the way and help nudge nervous colleagues along, she adds.

The secret to more adoption appears to be better education and demonstration of the visible benefits of going paperless. It may not be easy.

Learn effective site-specific strategies for moving to paperless operations at the ACRP 2017 Meeting & Expo session “Going Paperless: A Smart Way to Increase Site Efficiency and Save Resources.” This ‘master series’ session will teach site staff to effectively manage digital medical records, IRB submissions, communications, and more. View Program and Schedule

ACRP 2017 Meeting & Expo

Amanda Alonso, CCRC, a clinical research manager at Columbia, keeps a close watch on discussions taking place in ACRP Interest Groups and notes that “[e]ven recently, I’ve read where people are asking why their clinical research associate is pushing paperless on them,” she says. “We have to get the word out that this is feasible; it’s not as complicated” as potential users think, Alonso adds.

“No one wants to be the guinea pig,” says Kyusun Cha, a program manager at the University of California, San Francisco. His shop tries to piggyback off systems such as Microsoft Outlook or Adobe Acrobat. Because these are systems that most people already have, it takes some of the user trepidation out of the equation. “It might not be a perfect system, but it’s a starting point,” Cha says.

“We’re not there yet,” Alonso sums up. “We’re just hoping to help other sites and sponsors achieve these goals and save money and space the way we’ve been able to.”

Author: Michael Causey