OPEN SOURCE

By Deborah Borfitz

Oct. 27, 2008 | With its mid-September release of OpenClinica 2.5, Cambridge, MA-based Akaza Research has given pharmaceutical companies reason to take heed of the open source movement. Many features of the electronic data capture application are specifically designed for industry-sponsored clinical trials.

For starters, OpenClinica 2.5 runs out-of-box on the Oracle 10g database, not only the PostgreSQL open source database platform, says Project Manager Paul Galvin. Audit events can also be time stamped down to the second. It’s one of about 20 new auditing features of the new release.

Paul Galvin

Notable new site-specific capabilities include the ability to do complex cross-form and cross-field edit checks, ensuring only valid data get into electronic case report forms (CRFs), says Galvin. Investigators can also electronically sign for particular subject events or entire subject casebooks.

Study monitoring and query management tools and reports now include a “notes and discrepancies matrix” that allows users to get a full view, on a single page, of all new and open queries and notes regarding inconsistencies with sponsors’ data requirements, says Galvin. Monitors can close any queries that get a resolution proposal from sites. Full reports can be downloaded as a PDF or CSV file and put into an Excel database.

With OpenClinica 2.5, data extraction time has been slashed from five or six hours to two or three minutes for large data sets containing millions of items, says Galvin. That’s a particularly useful feature when running big trials with multiple sites involving thousands of subjects. The upgrade also allows the import of data from third-party systems specific to patient laboratory, imaging, treatment visits, and hospitalizations.

 External users of OpenClinica have contributed translations into French, Italian, and Portuguese for the latest release, says Galvin. Several users are also working on ad hoc reporting features that could be added to the source code within the next six months. OpenClinica’s data extraction module currently provides limited reporting capability.

OpenClinica doesn’t yet have any large pharmaceutical companies in its user base, says Galvin. But some sizeable clinical research organizations and smaller pharmaceutical companies are users of the application and have signed up for OpenClinica Enterprise, a commercially packaged version of the system they can more easily validate and support within their organization, says Galvin. They’re also able to access 260 tests of version 2.5 – nearly double the number conducted with the last update. “We wanted to make sure we got full coverage of all the features implemented…[without] affecting anything that was working correctly in the previous version.”

Akaza is recognized as one of the Enterprise Support Network partners for the Cancer Biomedical Informatics Grid (caBIG) program of the National Institutes of Health. As part of this program, Akaza also offers deployment support and training for parties interested in adopting caBIG’s open source clinical trials applications, says Galvin.

To date, OpenClinica has been adopted in 76 countries, with registered community members totaling over 5,000, says Galvin. The standards-based software facilitates protocol configuration, design of CRFs, clinical data capture, and study/data management. It is freely available for download on the Web at openclinica.org.

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