Issue VIII - January 2008

caBIG™ Tool Personalizes Care

With today's increased focus on individualized care, and a growing number of patients enrolled in multiple clinical trials, there's added emphasis on tracking specific patient activities and outcomes.

"Clinical trials are complex to model and run in part because several different things must occur in parallel — treatment regimens, patient monitoring and lab tests, and the patient's treatment schedule must adapt to the responses of the individual participant," 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.

"Also, when single participants are enrolled on multiple studies simultaneously, it can be difficult to attribute particular outcomes to the proper study. Tracking the events for each study for a specific research participant can be quite daunting."

Tracking from start to finish

Researchers at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University led the development of release 1.0 of the Patient Study Calendar (PSC), an open source, Web-based application that allows researchers to manage and track patient activities and progress throughout the clinical trials lifecycle. The PSC is a component of the Clinical Trials Compatibility Framework, and is available as a standalone application to any organization that would like to install it.

"The PSC can track and notify the clinical trial coordinator of events for a participant on a study, across all studies, or all of the events for a study on a per participant basis," said Kibbe. "This functionality allows a researcher to manage either that specific study calendar or all study calendars associated with a particular patient."

Researchers at Northwestern, led by Kibbe and working in conjunction with SemanticBits, are leading the development of the next release of the PSC.

Three PSC modules span the clinical trial lifecycle:

• 1) Template creation

  The PSC enables the creation of an abstract template that contains the specific parameters for a study that have not yet been applied to a patient. These templates can be saved and/or exported for future use.

  "The Patient Study Calendar enables researchers to create and version templates as needed, as well as export those templates for use at other sites that use the PSC," said Kibbe. "This functionality makes the data collection process more consistent and efficient, since end-users do not have to create a unique template for each study."
• Current adopters of the Patient Study Calendar include Northwestern University, the Mayo Clinic, and Thomas Jefferson University.

  2) Forecast development

  After a patient registers for a study, an individualized patient calendar is developed. The PSC doesn't replace the existing scheduling system for patients, but instead allows clinical researchers to track and manage specific patient events and protocol changes within a study.

  The PSC enables a site to have as many studies open as researchers need and to share calendar data between different PSC sites. It is used to track and manage both time- and event-driven (adaptive) elements in therapeutic and non-therapeutic trials, which allows researchers to better personalize trials based on patient actions and therapeutic responses.

  "With a therapeutic trial, especially in cancer, you may delay the next round of therapy until the patient recovers from the previous round of treatment, or until they hit a particular milestone," added Kibbe. "For instance, if a patient has an elevated white blood cell count after the first round of therapy, the protocol may specify that treatment should be delayed several cycles until that patient's white blood cell count comes back down to the specified range. This type of personalization helps to decrease adverse events and can improve study results and is very common in cancer trials."

• 3) Outcomes Analysis

  As the patient moves through the study, the system allows the researchers to enter real dates and times, as well as add links to the patient's personal appointments, lab results, and pathological data. The data analysis side works in conjunction with electronic data capture.

  "As a trial is moving toward completion, the PSC shows in a dashboard view where all of the patients are within the trial and what activities are still outstanding," said Kibbe. "This information can then be passed to a statistician so all of the data that is coming out of the trial can be appropriately evaluated."

A boon to patients

In creating the application, the PSC developers recognized that many users had specific infrastructures and systems already in place that they could not or did not want to replace. Thus, they made PSC standards as general as possible.

The PSC doesn't provide its own specific calendar view, so it's easy for users to export this information into different formats.

"What we didn't want to do is provide yet another calendaring system," said Kibbe. "If PSC users want to view it as a calendar, we gave them the ability to export a specific patient's calendar and put it into their own calendaring system."

Researchers then have the ability to share a patient's calendar directly with the patient, which can be very comforting.

"When a cancer patient first enrolls in a study it's typically a very new and very frightening experience," said Kibbe. "One of the most important aspects of the Patient Study Calendar, according to our patient advocates, is that it allows the patient to interact with their oncologist, surgeon, or physician, and it gives them a view of what their life is going to look like in a year.

"Suddenly they realize that their medical team expects them to be alive a year from now, something that, at least for new cancer patients, is a big reassurance."

Learn more:

For more information about the most current version of the Patient Study Calendar, visit: https://cabig.nci.nih.gov/tools/PatientStudyCalendar.

For more information about the Robert H. Lurie Cancer Center of Northwestern University, visit: http://www.cancer.northwestern.edu/home/index.cfm.

For more information about SemanticBits, visit: http://www.semanticbits.com/.