caBIG® in Action: New Models of Clinical Trials at Duke
By relying on caBIG® clinical trial applications, researchers at Duke University's Comprehensive Cancer Center are able to collaborate across institutional and international boundaries.
Multi-center Vaccine Trials
The days of using paper records to transfer patient registration data from an affiliate site to the coordinating center of a multi-center clinical trial may finally be numbered. Recently, Bob Annechiarico, Director of Duke's Cancer Center Information Systems (CCIS) and his colleagues have successfully implemented the Cancer Central Clinical Participant Registry (C3PR) at three sites participating in the PANVAC trial. PANVAC is a phase II vaccine study for patients with liver metastases from colorectal cancer headed by Michael Morse, M.D. at Duke University's Comprehensive Cancer Center.
"Before this, affiliate sites would fax patient information to us and someone here would have to enter the data," said Vijaya Chadaram, Clinical Trials Project Lead for C3PR. "Now they can do it themselves and we can see the patients registered in real time, giving us immediate and accurate information about our enrollment."
C3PR captures information such as consent, eligibility criteria, stratification, randomization, and screening in a secure application. It can be run by itself or as part of the caBIG® Clinical Trials Suite. "C3PR is a front end to the whole workflow of the clinical trial. It captures patient registration data and then hands the information off to other aspects of the suite," explained Pankaj Agarwal, Ph.D., C3PR Project Manager.
The PANVAC trial already relies on another component of the Suite, the Cancer Central Clinical Database (C3D), and so it was a natural choice for launching the multi-site capabilities of C3PR. "One of the goals of the development was to make it grid-capable and deploy it in a multi-center environment," said Annechiarico, "So we selected the PANVAC study to provide us with a use case implementation." The C3PR team was able to make the valuable adjustments to the software to enable it to run smoothly in a grid environment. Enrollment in the PANVAC trial is now complete.
Global Collaboration with Beijing Cancer Hospital
caBIG® is also helping Duke University Cancer Center cross global research boundaries by providing technology to facilitate a collaborative clinical trial with Beijing Cancer Hospital in China. This first-of-its-kind collaboration will bring together Eastern and Western medicine while establishing a relationship between government and regulatory bodies in the U.S. and China.
The project—a breast cancer clinical trial—will leverage the unique attributes on both sides. The U.S. offers strong technology and electronic infrastructure that will allow for greater study of the immense, diverse patient population in China.
Teams at each institution will simultaneously conduct identical breast cancer clinical trials, and the data from both studies will be compared to identify factors that may contribute to discrepancies in outcomes. caBIG® technology within the Clinical Trials Suite will ensure that the data from each study can be shared despite differences in language, culture, and technology.
This trial will also utilize the C3D for electronic data collection and storage, as well as caBIG® Adverse Events Reporting System (caAERS). Other tools, such as the caBIG® Cancer Central Clinical Participant Registry (C3PR) and tools for tissue management needs are under discussion.
Teams from Duke and China are currently using caBIG® for "mock" enrollment of trial participants prior to actual accrual.
