Clinical trials system is a research ‘gold mine’

OnCore will impact recruiting, project management

Sherwin Johnson

One of the more persuasive arguments for implementing the Epic Ambulatory electronic medical record application throughout Yale Medical Group (YMG) and the rest of the Yale New Haven Health System (YNHHS) was that the immense amounts of data generated would be a research “gold mine,” particularly in the area of clinical trials. As that data begins to flow, a second suite of software, the OnCore clinical trials management system can now capture it efficiently.

OnCore went live on July 8 in Yale Cancer Center (YCC) and will be implemented throughout the system over the next 18 to 24 months, said Tesheia Johnson, MBA, MHS, chief operating officer for the Yale Center for Clinical Investigation.

‘A huge leap forward’

“This is a huge leap forward for us,” said Johnson, a key member of the team that evaluated two dozen clinical trials management systems products this past year and negotiated a “terrific deal” with the ultimate winner, Wisconsin-based Forte Research Systems, to bring a customized version of OnCore to the medical research community. The $12 million, five-year contract, a joint purchase by YNHHS and Yale School of Medicine, was signed on May 5.

OnCore, used in tandem with Epic at Stanford, the University of California at San Francisco, the University of Wisconsin and other leading academic research centers enables investigators to greatly increase recruiting for clinical trials. The system also allows researchers to manage every aspect of a clinical trial, from budget to meeting regulatory and institutional review board scrutiny, in one place. Another plus is that OnCore is capable of securely sharing data from multiple research locations, which facilitates rapid and comprehensive biostatistical analysis.

Johnson explained that as part of the contract, Forte is building enhancements to OnCore’s functionality, which will enable automated randomization of clinical trials participants. “This is light years ahead of where we are now,” she said.

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World of clinical trials has changed

Thomas J. Lynch Jr., MD, director of Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital at Yale-New Haven, concurred. “The world of clinical trials has changed immensely in the past 25 years,” he said. “It was once possible to manage everything with a paper spreadsheet, but now you’d drown in a sea of paperwork. It has become impossible to do this kind of work without an automated system.”

Bringing OnCore to YCC researchers first will enable them to compile the year’s worth of data so that National Cancer Institute officials can look at it as part of the evaluation next year for recertification as one of the nation’s 40 comprehensive cancer centers. This kind of research tool and capability, said Dr. Lynch, “is considered a characteristic of a great institution. It’s something that every cancer center should have.”