The Clinical Trials modeling project is an initiative by the National Cancer Institute Center for Bioinformatics (NCICB) to model the clinical trials domain. The modeling project will provide the cancer research community with de-identified clinical trials data (data that has all patient identification information removed). The Clinical Trials modeling project contributes to the NCICB vision of developing a standardized infrastructure to connect cancer research information sources. An infrastructure based on the use of open standards and standards-based tools will enable the cancer research community to share, interpret, and integrate information.
The Clinical Trials Object Model (CTOM) is a key component of the NCICB clinical trials infrastructure. Represented as a UML class diagram, CTOM supports the Biomedical Research Integrated Domain Group (BRIDG) model. The BRIDG model is a collaborative effort by the clinical trials standards community to develop a UML model of the clinical research domain. The BRIDG model will represent the complete life cycle of clinical trials, from protocol planning and development to study execution to study analysis.
The focus of the BRIDG effort is to gain an understanding of the semantics of the domain. The BRIDG model uses the Health Level 7 (HL7) Development Framework to analyze the domain of protocol-driven biomedical and clinical research. The resulting UML class diagram describes the concepts, relationships, and semantics of the clinical research domain space.
CTOM will model data collected by Clinical Trials Data Management Systems (CDMS) for the initial implementation. The classes identified in CTOM are intended to be instantiations of the abstract BRIDG classes. Initially, CTOM will be a reference implementation of the BRIDG model in “Study Execution” phase only, as this iteration of CTOM will focus on use cases for Outcome related queries . As BRIDG evolves, additional use cases for CTOM will be identified. Eventually data from any Clinical Trials Data Management System (CDMS) or data source will be available to the cancer research community through Java APIs.
CTOM will be modeled and documented in Enterprise Architect™, an NCICB prescribed UML modeling tool.