UNC's study startup mapping tool wins WCG Innovation Challenge

The University of North Carolina at Chapel Hill (UNC) School of Medicine's innovative web-based solution to managing their trials' startup processes was crowned the winner of this year's Innovation Challenge at the 2023 MAGI East Clinical Research Conference in Philadelphia.

Many sites know full well the challenge in effectively and efficiently juggling the many startup tasks required for multiple trials, let alone a single study; this highly complex endeavor was what UNC School of Medicine decided it needed to solve and simplify, Catherine Barnes, the school's associate director of clinical research operations, told CenterWatch Weekly.

Following many study startup requests, she and a colleague first attempted to tackle the issue by putting their heads together on a diagram that made sense of startup processes. Their first attempt, which produced a "crazy-looking PowerPoint slide diagram," was not successful, she says, but it did lead to an eventual solution, a web-based tool named Bloom that multiple users work in to map out, manage and keep track of study startup tasks.

"We realized [that PowerPoint diagram] was going to be near impossible because of the fact that there were so many 'if this then that, if that then this,'" she said. Barnes thought, "I really wish I had a web developer or somebody to be able to make this into a program that could answer those types of questions."

Out of that wish grew Bloom, a web-based graph database that allows users to input general study information, such as trial name and target recruitment date, and answer more specific questions posed by the program, such as the type of IRB and investigational product to be evaluated. The output is a project management graph that gives users a visual of the trial's startup tasks, timelines and connections.

Development, which took almost a year and a half, was made possible by the university's web development team and the Clinical Research Support Office's data analytics team, with Barnes and her staff working with them to provide direction on how the program should map out study startup activities. To Barnes, their efforts stand as "a testament to team science."

Implemented at UNC around nine months ago, Bloom's graph database is flexible and modifications can be made as needed, allowing UNC to keep up with industry changes.

The graph, which reads from left to right, shows individual tasks in the form of squares, or "nodes," that are color-coded based on task category. Through its use of branches, the graph clearly distinguishes between tasks that can be completed concurrently and those that have dependencies.

Clicking on a square brings up a description, responsible parties, contacts, tips for completing the task when relevant, and other information that can be entered by system users. When a user marks a task complete, the completion date is automatically documented, though this can be changed and completions can be undone if necessary.

"You may have someone who's working on the budget, you may have someone who's on contracts, you may have somebody on regulatory. All three of those people can log in to the tool and see exactly where the process is," she said. "That way you're not potentially waiting on somebody to do something."

Each element of the program also contains feedback and bug report buttons that allow for immediate, real-time action to be taken on any issues and helps to refine the tool, Barnes noted.

In the future, she hopes they'll be able to incorporate the Critical Pathways project management technique in the system, which would allow them to use math to calculate deadlines based on startup activity target dates and timeframes.

They're also working to develop a process that will allow them to share Bloom with other sites. For now, she advises other sites to "really think big and outside the box" when it comes to study startup.

"One way we've been able to succeed in this and other initiatives … is because we do have a diverse team and it took a while for us to really see and understand exactly what pieces of the puzzle there needed to be," she said. "Even if you don't have that data analytics section, start mapping out your processes and recording things. The best time to start collecting data and record is right now."

In addition to the Bloom project, four other innovative efforts were honored as finalists:

• Hospitales HIMA San Pablo's application of oncology patient navigation principles beyond transportation assistance to improve trial participation and retention;
• Revival Research Institute's community health screening initiative at the Ann Arbor Art Fair, which enabled them to screen 354 patients over three-days for an Alzheimer's trial;
• Mercy Research's education and onboarding program, which involved the reassignment of a highly experienced coordinator to a research educator role and resulted in a more than 70 percent drop in staff turnover; and
• Cleveland Clinic Taussig Cancer Institute's multi-pronged strategy to onboarding new caregivers and mitigating burden for team staff vacancies. This approach, which uses a clinical research data trainer, a regulatory research trainer and float positions, has helped significantly reduce vacancy rates.