By Deborah Borfitz
Sept. 29, 2008 | Subject matter experts and information technology (IT) professionals involved in clinical trials should both be happier with the next release of BRIDG (Biomedical Research Integrated Domain Group), the domain analysis model aimed at synchronizing semantics within the clinical research and healthcare enterprises. Semantically speaking, BRIDG will be taking a “two-layer approach” that incorporates accepted clinical terminology and definitions as well as technical representations around which software programs and messages can be written.
So says Julie Evans, senior director of technical services at the Clinical Data Interchange Standards Consortium (CDISC). Five years ago, CDISC initiated construction of BRIDG to support harmonization of its own set of standards as well as to “interface more cleanly” with Health Level Seven (HL7), the standards-settings organization for electronic interchange of clinical, financial, and administrative information among healthcare-oriented computer systems. Since then, the National Cancer Institute (NCI), Food and Drug Administration (FDA), and HL7’s Regulated Clinical Research Information Management (RCRIM) Working Group have joined the effort.
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| Julie Evans |
BRIDG is currently a “mix” of technical and domain expert semantics, says Evans. But an alpha version of the two-layer model is expected to be available later this fall, improving the ability of all user types to understand and use BRIDG. There will be mapping between the two levels of semantics that will, for example, allow computers to unambiguously process words describing such concepts as vital signs and adverse events in a semantically interoperable way.
The only significant implementer of BRIDG at the moment is the NCI’s Cancer Biomedical Informatics Grid (caBIG) initiative, an information network enabling all constituencies in the cancer community – researchers, physicians, and patients – to share data and knowledge. The data analysis model was adopted in 2005 by RCRIM, which is working toward creation of BRIDG-based messages for the interchange of data within and among trial-sponsoring companies and the FDA, says Evans.
Last year, the FDA included BRIDG in its five-year IT plan as a foundation for several projects. Requirements about how sponsor data is to be sent to the FDA is being negotiated among BRIDG stakeholders, says Evans.
One of the goals of BRIDG is to achieve computable semantic interoperability in protocol-driven research and healthcare, so that computer systems precisely understand terms and their meaning and can thus effectively communicate, says Evans. The other goal is to allow clinical trial data to be connected to electronic health record (EHR) data. Substantial progress has been made on the first goal, in that nearly all standard clinical trial information such as patient demographics and other safety information have been semantically described. Disease-specific terms are not included and it has yet to be determined which ones will be. “Even with what we have so far, the scope is huge,” says Evans.
BRIDG follows the HL7 Development Framework because it’s an accepted, step-wise way to develop HL7 messages, says Evans. “There is no other framework for this, other than generic ones for software development” whose vernacular is not specific to HL7 message development.
CDISC is also involved in solutions to such hurdles as the acceptance of digital signatures by the CDISC Operational Data Model and electronic capture of trial data directly from EHRs.
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