Clinical Trials Management Software in Action at Duke University
Michael Morse, M.D., M.H.S., a gastrointestinal oncologist at Duke University’s Comprehensive Cancer Center in Durham, NC, has long been interested in the use of cancer vaccines to prevent colon cancer recurrence. His latest endeavor is a clinical trial focused on a vaccine called PANVAC. Because of the trial’s stringent recruitment criteria (for instance, patients must have had any metastatic liver tumors removed before enrolling), Morse needed to accrue patients from multiple cancer centers to ensure that he had enough participants to draw meaningful conclusions.
The logistics of managing data in a multi-center trial can be daunting. Without automated tools, many clinical data managers resort to collecting and manually compiling data from multiple spreadsheets, a process that is cumbersome, time-consuming, and can introduce human error into the data. Knowing this, Morse consulted Bob Annechiarico, Director of Duke’s Cancer Center Information Systems (CCIS), when he began to plan for the PANVAC trial.
As participants in the caBIG™ Clinical Trials Management Systems Workspace, Annechiarico and his colleagues at Duke are well versed in the software tools that make up the caBIG™ clinical trials management systems suite. Annechiarico recommended that Morse use a component of that suite, the Cancer Central Clinical Database (C3D), an FDA-compliant trial management platform for his clinical trial.
Managing the Multi-Center PANVAC Clinical Trial with C3D
C3D, a web-based application, facilitates multi-center trial data collection using standardized templates to collect, track, audit, and electronically submit data. The application can be hosted locally at an individual institution, as Duke has, or at the National Cancer Institute’s Center for Biomedical Informatics and Information Technology (NCICBIIT). C3D can also be applied in a secure manner to conduct multiple site trials.
Annechiarico commented, “Those who are using C3D find a great deal of security in the use of the software. This is a solid platform with all the controls you need to maintain stringent patient privacy.” Annechiarico’s colleague Mohammad Farid noted that, “Investigators now realize that the tool is scalable, and can incorporate multi-forms and multi-sites.” Depending on the individual needs of the researchers, the Duke CCIS staff—which received an Outstanding Achievement Award at the 2007 caBIG™ Annual Meeting—can adjust the templates for data collection. As noted above, the CCIS deployed C3D locally on their own server, and manages their own data using common data elements employed by NCI. The CCIS staff also help coordinate the adoption of C3D at collaborating centers (in the case of Morse’s PANVAC trial, M.D. Anderson Cancer Center in Houston, TX; H. Lee Moffit Cancer Center in Tampa, FL; Lombardi Comprehensive Cancer Center in Washington, DC; Wake Forest University Comprehensive Cancer Center in Winston-Salem, NC; Providence Cancer Center in Portland, OR; and Hollings Cancer Center in Charleston, SC).
Early Results and Future Expectations
While PANVAC is still in its early stages, the technical staff and researchers all have high hopes that it will have a significant impact on the quality of life of patients with colon cancer. C3D securely stores the data from the twelve patients enrolled thus far from Duke and the six collaborating centers. Morse expects to collect data from an additional 60 patients. “Now we can easily download the data from all the participating sites, consolidate it quickly for review by a statistician, and then give the information to the data monitoring committee,” Morse explained, “otherwise the process would have been less convenient with Excel spreadsheets, faxes, and manual data entry.”
“A major problem in immunotherapy research is that it is very hard to compare data from different centers” Morse added. “If everyone were to do data collection the same way, then it would be much easier to put information together. Using C3D, we know that all of the data will be compliant with caBIG™ standards.
“It won’t take much convincing to encourage other researchers to use these tools,” he concluded.
Annechiarico agreed. “Our IT staff is having a hard time keeping up with the demand because so many researchers at Duke want to use C3D for their clinical trials. Everyone recognizes the value and power this tool brings to their clinical research.”
“Using information technology to catalyze the modernization of the clinical trials process has been a primary objective of caBIG™,” said John Speakman, NCICBIIT’s Associate Director of Clinical Trials Products and Programs. “In particular we have sought to facilitate the conduct of dynamic, collaborative, multi-center trials like the ones occurring at Duke. We’re not just trying to enable the cancer research community to run trials more efficiently, we’re trying to do this on a common foundation that will eliminate the huge overhead around running complex, multi-center trials.”
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