C3PR: Enabling Cross-Institutional Clinical Trials Management
caBIG™ tool streamlines maintenance and use of patient information
Cancer clinical trials have traditionally been conducted in isolation by local cancer centers because a centralized, interoperable patient registration and placement system—as well as common data elements—did not exist. This lack of coordination and standardization makes creating large datasets across institutions difficult, and researchers have often found it challenging to glean statistically significant results from smaller datasets.
“The challenge with cancer trials is that they can be relatively small and short term, and this is where they differ from clinical trials in other areas such as cardiovascular medicine and neurology, where trials tend to be larger and longer in duration,” said Bob Annechiarico, Director of the Cancer Center Information Systems (CCIS) at Duke University’s Comprehensive Cancer Center. “Being able to eventually combine data from multiple trials, taking advantage of common data element (CDE) structure, provides one with a platform for greater exploration, far beyond the isolation of current clinical trial silos.”
“C3PR essentially handles the full lifecycle of patient registration for clinical trials, from eligibility to stratification to randomization.”
-Patrick McConnell, Duke University
“Interoperable systems, both home-grown and vendor developed, when rooted in caBIG™ standards and libraries, will allow us to better link trial data together and create the type of meta-relationship that will support this exploration, someday perhaps even virtually,” Annechiarico continued. “This will permit us to see the relevant impact of our cancer interventions.”
Tackling the challenges of clinical trials with C3PR
The Cancer Central Clinical Participant Registry (C3PR) application directly tackles some of the challenges associated with registering patients to open, IRB-approved clinical trials, which can include issues associated with finding appropriate numbers and types of patients for clinical trials. C3PR also meets other challenges that are inherent in cancer clinical trials in a secure, regulation-compliant way.
Some of these challenges include: accurately tracking patient history (especially when multiple studies are involved); adhering to HIPAA and other regulations and guidelines; and maintaining patient eligibility for current or future studies.
Learn more about how the Lombardi Comprehensive Cancer Center at Georgetown University Medical Center is using C3PR and other caBIG™ applications.
“C3PR essentially handles the full lifecycle of patient registration for clinical trials, from eligibility to stratification to randomization,” said Patrick McConnell, senior Manager of Software Development for the Bioinformatics Group at the Duke University Comprehensive Cancer Center.
“This patient registry standardizes how patient data is collected and exposed,” added 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.
“By providing a foundation for all other data collection and dissemination efforts at institutions like ours, C3PR ultimately expands the population of a clinical trial and allows researchers to more quickly achieve useful results,” said Clarke.
While adhering to caBIG™ security standards, C3PR, a grid-enabled, Web-based application used to manage participants in cancer clinical trials, provides a central point of data entry and storage for sensitive patient information. It also provides an infrastructure that makes participant consents, contacts, demographics, and participant-provided data available for multiple research uses.
C3PR also provides the cancer research community with a unified infrastructure to collect and manage clinical trials data. Specifically, C3PR allows a clinical trial registrar to add a patient to a central repository in real time, avoiding the usual lag associated with periodic reporting. This feature is particularly important for researchers from the Lombardi Comprehensive Cancer Center at Georgetown University, who work directly with centers in the Lombardi MedStar Research Network.
“Because all of our groups used their own localized systems for registration, we would only receive data periodically,” said Jieping Li, Program Analyst at Lombardi. “But C3PR has made getting data faster and easier, and the network’s direct input has greatly streamlined the process.”
For example, once a patient is entered into the system, C3PR enables registrars to more accurately record vital patient information for the study such as the date the consent to participate in the study was signed, the date the registration initiates, and whether the subject meets all of the eligibility requirements.
“C3PR is patient-centric and trial-centric, depending on what you want to review,” said Annechiarico. “If you’re looking at a pool of patients who are participating in one or more trials, you can choose to review the patient or trial experience.”
“In the initial development it was critical to have both ways of viewing registrations, whether it be by patient or looking at sort of a global study view,” added McConnell. “So, for example, a registrar can sit down and select the study first then add the subject, or the registrar may know the subject and then register the subject on a trial.”
C3PR Version 2.0: "Interoperability without Interdependency"
The current version of C3PR, version 1.0, was developed in partnership between the NCI Center for Cancer Research (CCR) and the NCI Center for Bioinformatics (NCICB) and released as a pilot in December 2006. Adopters for the pilot include the Lombardi Comprehensive Cancer Center at Georgetown University, the University of California – Irvine, and the NCI CCR.
Duke University Comprehensive Cancer Center is currently leading the development of version 2.0, which is scheduled for release in early 2008 as part of the Clinical Trials Compatibility Framework. Version 2.0 will also be available for individual download.
“C3PR is getting really close to a one-stop-shop for patient registry, which I think will be a great asset to the caBIG™ clinical trials suite,” said Annechiarico. “Once this next version of C3PR gets rolling, there will be a lot of features within C3PR for people to pick from.”
Because many cancer centers have existing systems that they are either unwilling or unable to replace, C3PR is available in a modular format that allows a Center to adopt whatever components of the tool most fit their needs.
“Some of the functionalities that we are implementing in version 2.0 are for multi-site trials that allow registrars at affiliate sites to register their participants locally, within their own systems, and then exchange that patient and registration information with the coordinating site,” said McConnell.
“But the cornerstone, the real critical piece to achieving the interoperability needed to accelerate biomedical research is to have these different sites ultimately sharing systems and data that conform to caBIG™ standards, so that these different sorts of interactions are possible.”
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