Improving Efficiency of Clinical Trials with C3PR
caBIG™ in action at Georgetown University Medical Center’s Lombardi Comprehensive Cancer Center
A key feature of effective and efficient research is minimizing errors due to manual data entry while maximizing cross-study correlations. In many clinical trials, however, collection of a patient’s identification information is often repeated at several points in the trial; for example, during the initial entry into the clinical trial as well as during visits to different hospital departments.
This manual data entry is not just inefficient, but inaccuracies caused by human error can potentially impact the validity of a study or studies and introduce additional time, costs, and data discrepancies. That is why implementing tools like the Cancer Central Clinical Participant Registry (C3PR) has been a huge boon to researchers like Jieping Li, Program Analyst in the Clinical Research Management Office of the Lombardi Comprehensive Cancer Center at Georgetown University.
“Previously, we received monthly or quarterly e-mails and had to manually enter all of the patient information for those participating in a given trial,” Li explained. “With C3PR, we are able to directly input the data into our system, which streamlines the whole process and greatly decreases the amount of time we spend on data entry.”
Georgetown University’s Successful Team Efforts on caBIG™ Projects:
Li, who manages IT support for Lombardi therapeutic clinical trials, led a pilot project last year that demonstrated the capabilities of C3PR version 1.0 for clinical trials. C3PR is a Web-based, participant-centric application that helps manage clinical trial data across multiple cancer clinical trials.
“We have several hospitals in the Lombardi MedStar Research Network that all participate in the same trials,” Li said. “By using C3PR, all of the registration processes are coordinated, which means that information from patients admitted at one hospital, but treated at another, does not need to be entered more than once into the system.
“C3PR also prevents duplication errors of enrollment information and allows for data to be directly transferred into C3D.”
Lombardi is currently running three clinical trials using the Cancer Central Clinical Database (C3D), a clinical trials management software program developed through the caBIG™ initiative.
“In version 1.0, the data is de-identified when it is transferred out of the local database to other sites,” Li explained. This process allows collaborating institutions to view data, but not private patient information. “We are able to get customized reports from C3PR, or we can set up the reports using our own templates.”
In early 2008 Li plans to implement C3PR version 2.0, which is being developed by Duke Comprehensive Cancer Center, for Lombardi’s clinical trials. “Right now, there is an urgent need to share clinical data with proper security measures between MedStar hospitals,” Li said.
These hospitals collaborate on clinical trials, and patients may visit one or more hospitals in the Network. “We expect that with C3PR version 2.0, that sharing will be safe, easy, and efficient,” Li added.
Leading Successful caBIG™ Programs at Georgetown University
When the caBIG™ initiative was first beginning at Georgetown University, a leadership team was formed with representatives from three groups: Lombardi Comprehensive Cancer Center, Advanced Research Computing (ARC), and Protein Information Resource (PIR). The team is led by Robert Clarke, Ph.D., D.Sc., Professor of Oncology and Physiology and Biophysics and Interim Director of the Biomedical Graduate Research Organization at Georgetown University Medical Center.
During monthly meetings, the team discusses individual projects as well as meetings and teleconferences attended by team members. Members of the team find ways to assist each other or to collaborate on projects.
ADVICE FOR NEWCOMERS:
Jieping Li, Program Analyst, Lombardi Comprehensive Cancer Center:
- Review ALL tools to determine which one(s) are the best fit for your institution.
- Pick one with best fit to get started and then add additional tools.
- Actively participate in caBIG™ through Workspaces and teleconference calls.
Baris Suzek, Research Associate, Protein Information Resource (PIR):
- Use the website to find partners and to understand the resources that are available.
- Find a good partner institution or group that has expertise in the deployment and use of the existing applications.
- Work with the training and mentoring program.
“We pool resources to pick the best and most relevant projects to work on, enabling us to apply the best talent available to each job,” said Stephen Moore, Director of ARC.
“Bringing people together from different subject and domain areas and putting them together is more critical than having one person covering all areas,” Li added.
“We understand that it’s necessary to put our efforts on the front end of data collection to improve efficiency so that the resulting analyses at the end of the study are accurate,” Li continued. “We strongly believe these tools can eventually solve data management challenges to reduce duplication of data entries and to provide access to important data from multiple clinical trial sites.”
Efforts at Georgetown to implement caBIG™ tools are built on a vision expressed by Clarke.
“The ability to integrate multiple types of cancer research data within and across cancer centers and to connect cancer researchers is a powerful and enduring vision that will allow cancer researchers to achieve their full research potential,” he said. “Cancer clinical trials are the cornerstone of translating research from academic centers into routine standard of care.”
Lombardi will be hosting a caBIG™ Summit on January 11, 2008, which will include demonstrations of several caBIG™ tools, including a presentation on C3PR by Li.
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