By Deborah Borfitz
January 5, 2009 | The free, open source clinical trials software tools of the cancer Biomedical Informatics Grid (caBIG) have been downloadable, in a single bundle, from the website of the National Cancer Institute (NCI) Center for Biomedical Informatics and Information Technology since early last year. With November’s release of the caBIG Clinical Trials Suite (version 1.1), individual components also have newfound speed and simplicity of use.
The Suite, overall, can be more easily configured and installed and has enhanced user interfaces and documentation, says John Speakman, associate director of clinical trials products and programs for the Center. While the software has been crafted in response to the needs of clinical researchers in oncology, it is “by and large generic” and thus widely applicable beyond cancer.
The idea is to “surround” electronic data capture (EDC) systems with management tools specific to sites and patients, says Speakman. It is also to demonstrate that disparate groups can “share data in a reliable, trustworthy way” across trials so as to spot important disease patterns. Use of the six-module caBIG Clinical Trials Suite is voluntary and no one is tracking its usage, but about 200 organizations (representing roughly 1,000 individuals) currently participate in the caBIG community.
The Suite includes a Clinical Participant Registry enabling clinical trials staff to track study subjects across multiple trials and sites. With the recent upgrade, the repository supports companion protocols, such as quality-of-life studies, which may be tied to a central therapeutic trial, says Speakman. Notification features have also been improved so that sites can set up rules for notification events.
The Suite’s Patient Study Calendar delineates “what happens when” for sites and patients and is able to adjust when the patient schedule changes, such as when an adverse event occurs. Sites can now use the module to self-style ad hoc reports on such topics as protocol compliance, says Speakman. They can also re-use study calendar templates, avoiding rework on complex trials. Sponsors, like the NCI, can likewise generate calendar templates on behalf of sites.
The Adverse Event (AE) Reporting System component is pre-programmed with the basic rules about NCI reporting, such as when an AE report must be expedited, says Speakman. But study investigators can also set up and edit their own AE-related rules. With the latest iteration of the module, they can also locally manage non-serious AEs in a more streamlined fashion. The system has a new “alert panel” whereby sites can monitor potential problems—as indicated by an out-of-range lab value, for instance—without opening up an AE report.
Study-defined solicited AEs, which sites are specifically required to ask patients about, are also now distinguishable from patient self-reported AEs, says Speakman. Sites can more easily import and export rule sets and information about subjects between instances of care as well as customized reports. The AE system also now enables coding of AEs using versions 10 and 11 of the Medical Dictionary for Regulatory Activities.
The Clinical Data Exchange application of the caBIG Clinical Trials Suite now integrates with open source databases and allows transfer of information other than lab data, says Speakman.
The other two modules of the Suite, which remain relatively unchanged, are the Clinical Trials Object Data System Lab Viewer—whereby lab data can be viewed and queried and subsets of tests can be sent to a clinical trials database—and a connector to the NCI’s EDC system (C3D), says Speakman. “Down the road, we hope to see a bunch of connectors for all the different EDC systems.”
As it is, organizations with in-house software engineers have been taking advantage of the software’s open source distribution to integrate the caBIG tools with their legacy EDC and clinical data management systems, says Speakman.
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