Patient Management Gets a Boost: caBIG« in action at the Robert H. Lurie Comprehensive Cancer Center
FedEx is famous for collecting and delivering millions of packages every day. But keeping track of thousands of patients in clinical trials is an even more daunting task.
So researchers at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University set out to give clinicians, research nurses, and clinical research associates (CRAs) the tools they need to manage, analyze, and share patient study information.
"The countless clinical trials being conducted, specifically for cancer, are an example of how dedicated researchers are to improving the standard of care for this disease," explained Timothy Volpe, Associate Director for Administration at the cancer center. "We make a palette of clinical trials available to our patients and have hundreds open at a time."
How they did it
Northwestern partnered with the National Cancer Institute (NCI) to develop the caBIG« Patient Study Calendar (PSC), a Web-based application that enables clinical trial managers to schedule and manage treatment and care events for each participant in a clinical trial.
"The Patient Study Calendar allows us to manage the more than 7,000 patients we have across our nearly 700 active cancer clinical trials," said Warren Kibbe, Ph.D., Director of Bioinformatics at the Robert H. Lurie Comprehensive Cancer Center and Research Associate Professor in the Center for Genetic Medicine at Northwestern University. "Through our collaboration with caBIG«, we were able to improve upon our own patient study calendar, and this new tool is now free and available to anyone who wants to adopt it at their site."
The PSC is a module within the Clinical Trials Compatibility Framework produced by caBIG«. As such, its utility is not limited to researchers at Northwestern; instead, it is available as a standalone application to any organization that would like to install it.
Getting smarter results, faster
"Currently, it is difficult for analysts and statisticians to get compliance and timing data for all the events that occur during a trial," explained Kibbe. "The Patient Study Calendar has helped us to overcome that obstacle."
The PSC allows the exchange of important data and study participant information among different institutions using different software for related purposes. For instance, Northwestern uses the PSC to generate lists for phlebotomy or for other specimens for the clinic so the CRAs, pathologists, doctors, and nurses are aware of when study participants are scheduled for treatment.
Developing the next generation
New features are already in development. When version 2.0 of the PSC is released, Northwestern will use it to:
- Estimate the workload and cost of running individual studies;
- Track events to which the clinical research associates and research nurses need to pay special attention or for which they need to schedule resources; and
- Analyze data for compliance and off-tracking of participants in a study.
Everyone plays a part
"The promise of caBIG« is improving trial availability, minimizing the regulatory and administrative burden of opening and running multi-institutional trials, and accelerating the improvement of patient care by incorporating the very latest and best of evidence-based medicine," said Volpe.
Volpe recommends "total involvement" when adopting a caBIG« tool. Technicians, clinical researchers, research pathologists, biostatisticians, biomedical informaticists, and clinical trialists all have a role. "The institution must also make a commitment to ensure that the data sharing and regulatory policies required for caBIG« can be implemented," said Volpe.
"caBIG« tools and frameworks can help you better understand some of your own practices and workflows, by giving you access to the best practices that have been developed by the more than 80 institutions that have been engaged in caBIG« during the past four years," said Kibbe.
"We have found that benchmarking our processes, policies, and procedures involved in clinical trials has provided very useful information for our researchers, IRB, financial, and legal staff. The collective wisdom of the cancer community is now embedded in caBIG«.
"caBIG« also offers the advantage of promulgating open standards for data sharing and open source software such as the Patient Study Calendar. All the caBIG« tools have been developed with the input and collective understanding and are far better than what any one institution can achieve. The time is now to realize the benefits of caBIG«-compatible tools like PSC."
- For more information about the Robert H. Lurie Cancer Center of Northwestern University, visit: http://www.cancer.northwestern.edu/home/.
- Clinical Trials Management Systems Workspace (CTMS)
- Tissue Banks and Pathology Tools Workspace