The Board of Directors of the Clinical Data Interchange Standards Consortium (CDISC), and the National Cancer Institute Center for Biomedical Informatics and Information Technology (CBIIT), are pleased to announce the production release of version 1.0 of the Biomedical Research Integrated Domain Group (BRIDG) model, available now. Version 1.0, represented in the Unified Modeling Language (UML), is available for download immediately from https://cabig.nci.nih.gov/inventory/infrastructure/bridg/.
BRIDG is a domain analysis model representing protocol-driven preclinical and clinical research. It was developed to provide an overarching model that could readily be understood by domain experts and would provide the basis for harmonization among standards, both within the clinical research domain and between biomedical/clinical research and healthcare. Three important streams of development have been brought together into this collaborative framework:
· CDISC: In early 2004, CDISC started constructing a Domain Analysis Model to support harmonization of their standards for clinical research as well as with the Health Level Seven (HL7) healthcare standard.
· NCI: In late 2004, NCI's Cancer Biomedical Informatics Grid (caBIG™) initiative joined the CDISC BRIDG efforts to construct a structured protocol representation for its Clinical Trials Management Systems (CTMS) Workspace, in order to further interoperability among clinical trials research in cancer.
· HL7: In 2005, the BRIDG model was adopted by the HL7 Regulated Clinical Research Information Management (RCRIM) Technical Committee as the RCRIM Domain Analysis Model.
The model thus emerged from an unprecedented collaborative effort among clinical research experts from CDISC, the US National Cancer Institute (NCI), the US Food and Drug Administration (FDA), Health Level Seven (HL7), and other volunteers. Leaders of the effort, working through the BRIDG Technical Harmonization Committee, include Julie Evans (CDISC), Doug Fridsma (University of Pittsburgh Medical Center/NCI-caBIG™); Smita Hastak (ScenPro/NCI-caBIG™) Charlie Mead (Booz Allen Hamilton/NCI/HL7 RCRIM).
The effort is being integrated into RCRIM’s application of the HL7 Development Framework (HDF). All CDISC and HL7 RCRIM standards will be harmonized with BRIDG, as governed by, and with priorities set by, the BRIDG Advisory Board, which has representation from all the primary stakeholders (CDISC, FDA, HL7 and NCI).
The maturity and value of the BRIDG model were manifest in the success of the recent CTMS Workspace Interoperability (CTMSi) project conducted as part of NCI’s caBIG™ program. First demonstrated at the February 2007 caBIG™ Annual Meeting in Washington, DC, the CTMSi project leveraged the fact that three of the five involved applications had previously harmonized their static analysis models with BRIDG. Despite being developed by separate teams, the applications were able to exchange data using harmonized BRIDG terms rather than application-specific terms, since many of the application-specific terms had been previously harmonized to BRIDG concepts. BRIDG thus greatly enhanced the speed and efficiency by which the five development teams participating in the CTMSi project were able to exchange semantically interoperable data.
The CTMSi project clearly demonstrated the value of using BRIDG as a common analysis model. As a result, the caBIG™ CTMS workspace is adopting a “BRIDG-powered Application Development Framework”. All applications developed within the workspace will not only be harmonized with BRIDG but will also have their harmonized semantics registered in NCI’s Cancer Data Standards registry (caDSR) as required for all caBIG™ Silver compatible software systems. Henceforth all CTMS workspace application development teams will utilize the BRIDG model when doing application analysis work. They will submit to the BRIDG Technical Harmonization Committee (THC) appropriately defined dynamic and static semantics for harmonization with, or addition to, the BRIDG model, thereby continuing to grow the content of BRIDG. Application analysis models based on BRIDG will, in turn, be registered in the caDSR, thereby ensuring that BRIDG semantics will form the basis for semantic interoperability within the workspace.
Sufficient experience and content has now been assembled to warrant a first production release, and a follow-on release schedule, for BRIDG. The BRIDG release schedule will coincide with HL7’s harmonization schedule - following Release 1.0, there will be quarterly releases of the BRIDG Model, with Release 1.1 scheduled in October 2007, Release 2.0 in January 2008, and so on.
The decision to formalize the release is intended to allow the larger community to be able to reply on formal processes and procedures around BRIDG, and ensures that application developers who would like to claim ‘BRIDG compliance’ can point to a specific BRIDG content with which they are compliant. Furthermore, it establishes formal procedures that are rigorous enough to justify the workspace registering BRIDG elements in caDSR.
BRIDG version 1.0 represents the formal publication of harmonized static content. It also contains exemplar dynamic content, extensive release notes, improved presentation and a smaller footprint for download than previous versions of BRIDG. Future releases of the BRIDG model will bind vocabulary to each of the BRIDG attributes. The vocabulary and terminology identification will be done collaboratively by all the BRIDG stakeholders. Binding to HL7 V3 data, while limited to two data types in Release 1.0, will be expanded to include all BRIDG attributes over the course of the next one or two releases of the BRIDG Model.
NCI will be inviting additional community participation in the BRIDG project. NCI values the collaborative nature of BRIDG and the importance of working on a common domain model that each of the four BRIDG stakeholder organizations – NCI, CDISC, FDA, and HL7 RCRIM – can utilize as the basis for both application development and data/message specification. NCI plans on identifying and supporting individuals interested in working on the BRIDG Project and advancing the NCI’s commitment to, and knowledge in, the BRIDG Project.
The BRIDG Model serves to bridge standards, as well as organizations and various communities, including academic research institutions and pharmaceutical product development organizations and related service and technology providers. It is also bridging the gap between clinical research and healthcare.
NCI CBIIT and the CDISC Board of Directors are committed to supporting BRIDG, and more importantly to using it as the basis of application development and standards harmonization, respectively. The release of BRIDG 1.0 reaffirms this commitment to a successful continued collaboration.