By Deborah Borfitz

May 16, 2019 | Under the best of circumstances, transitioning from one clinical trial management system (CTMS) to another is never easy. Swapping out an institutional review board (IRB) system at the same time only adds to the complexity. Do both at scale and it becomes an intricate dance requiring lots of rehearsals and impeccably timed maneuvers to pull off.

Just ask Denise Snyder, associate dean for clinical research at Duke University School of Medicine, home to the world’s largest academic clinical research organization. Last May, Duke went live with a new set of information systems designed to create a standardized clinical research experience for all biomedical researchers across the life cycle of their studies. All told, the migration took well over two years to stage.

Massive Undertaking

It was a big-bang deployment because a phased rollout wasn’t an option. "Trying to run an old [eIRB] system that was on a lifeline was a big reason we had to go with the whole enchilada," Snyder explains.

The Duke Office of Clinical Research (DOCR) supports a lot of research—more than 21,000 patients enrolled in 1,022 studies during FY2018—yet until recently research staff had few available IT tools that provided true clinical research management of studies, Snyder says. Apart from oncology studies, researchers had stopped using the previous CTMS entirely. Enrollment and billing calendars, plus orders, were all set up by DOCR and used by study teams in Epic’s electronic health record application.

Duke IT drove implementation of the first CTMS starting back in 2006, but "over-customized" it trying to please everyone, and the business was fragmented at the time, says Snyder. Epic went live for all of Duke Health in 2013, and it did not go well. "Research was left behind," both because it was not considered a critical path by the health system and Epic did not know how to train on research. "We were really stuck figuring out a lot of things [on our own]," much of it in an unfamiliar medical records workflow that research staff spent little time in for study-related activities.

The possibility of a 2005-era eIRB system crashing was also a daily worry, Snyder adds.

By popular vote in 2015, the research community chose Forte Research Systems' OnCore Enterprise Research CTMS—now used by over 100 AMCs, cancer centers, and health systems—and contract review began in 2016. Migration to OnCore in May 2018 was a massive project involving interfaces with not only Epic Maestro but also SAP accounting software and a new-to-Duke IRB software from iMedRIS called iRIS.

The three interfaces were "purposeful, so we could minimize duplicate entries of the same information in multiple systems," Snyder notes.

The OnCore implementation at Duke was one of the most successful ever for Forte, says Orla Mester, senior vice president of operations. "Exceptional leadership" by Snyder and other Duke leaders and a "clear vision for what Duke wanted to achieve with the system" were the chief reasons. The average time to go-live for an OnCore implementation of this magnitude has since been reduced to between nine to 12 months, she adds, with Forte providing more hands-on support for workflow development, change management and system adoption.

Importantly, Duke's target was long-term success with OnCore "rather than just getting the system live," continues Mester. "Duke has a very innovative and effective end-user training program and a strong adoption plan that focused on post-go-live user support."

While it was necessary for Duke to tie its OnCore go-live to the iRIS rollout, parallel system implementations are challenging to manage and generally not recommended, says Mester. Regardless of the approach—enterprise-wide from day one or staged rollout—the key to success is aligning resource plan with project scope.

Required Training

The budget for the five-year project plan included resources for new hires to supplement existing teams as some of the work previously done in Epic moved to a calendar build in OnCore, says Snyder. Project work groups are overseen by project teams governed by executive leadership. In addition to Snyder, project champions were Lisa Varani, associate dean in finance, and Cory Ennis, associate dean for clinical research information systems.

Prior to go-live with OnCore, 11 data fields were required for migrated studies, says Snyder. After go-live, minimum data capture requirements around studies ("minimum footprint") was upped to 38. All open studies in the IRB, and all closed studies since Jan. 1, 2013, were subject to migration. Duke has 21 research units, so nearly 40 people were needed on the implementation team.

CTMS training is role-based and completion with an 80% or better test score is required to gain access to the OnCore system (for more than 1,600 trainees in all), and "adoption has been well received for the most part," says Snyder. DOCR continues working to reduce user burden among groups who have never had to centrally track or manage enrollment, as well as those with non-prospective enrolling studies where summary accrual and minimal study information needs to be documented.

More people in DOCR are comfortable using the OnCore application and familiarity with Epic has increased, she adds. Training on iRIS was optional and "lacking" because Duke relied on vendor training materials that were not delivered. However, DOCR has worked closely with the IRB and IT to improve training and support for the iRIS application by offering office hours, tip sheets, online trainings and a soon-to-launch "on demand" support line where researchers can get help in the application right when they need it.

DOCR continues to offer instructor-led OnCore refresher classes, "at-elbow champions," and an online support page with a menu of required courses by functional role, information on how to make support requests and FAQs, says Snyder. OnCore champions also gather monthly for popular Facts & Snacks meetings to learn more about the system and discuss changes to workflow, helpdesk requests, and issues being experienced by people "in the trenches."

Building on Success

The initial big goal—going live with the new systems and changing the workflow—has been achieved, says Snyder. By this summer, DOCR intends to have migrated data from the minimum footprint on all new studies for fiscal year 2019. "This is substantial work for study teams," she says. "We are now looking at workflow improvements and getting all industry-sponsored financials into OnCore and standardizing that experience."

Moving forward, DOCR plans to integrate other Forte research tools into OnCore that will directly benefit study teams, says Snyder, including electronic data capture and regulatory management tools. Duke will also start looking at insights related to research analytics, such as increasing receipt of funds from study sponsors, and efficiencies that are starting to be realized.