What are Biomedical Concepts?
CDISC Foundational Standards, Controlled Terminologies, Therapeutic Area (TA) Standards and other models and standards capture clinical and translational research concepts. These concepts are granular, and not necessarily linked to one another. Case report forms (CRFs) used to capture clinical trial data rely on linkages between and among concepts. CRFs also frequently contain logic, such as which values are allowed for a given field, when one field is a value calculated from other fields, and when some fields are not relevant based on an answer to another field i.e., skip logic. CDISC refers to the relationships and logic for related groupings of granular concepts as biomedical concepts, and making these concepts available in SHARE is a critical part of our roadmap.
How does SHARE support Biomedical Concepts?
To support the automated creation of CRFs in electronic systems that implement SHARE’s metadata content, the relationships among variables, subsets of controlled vocabularies, rules and logic must be incorporated into SHARE. CDISC’s Biomedical Concept modeling staff have begun to create concept maps using the Cmap tool that illustrate Foundational and TA concepts in a way that is machine readable and intuitive to biomedical experts who may lack bioinformatics expertise. SHARE tools read these concept maps and automatically bind them and their controlled terminologies with standard terms from the National Cancer Institute’s Thesaurus (NCIt) to achieve greater compliance.
Because Biomedical Concepts model what relationships exist among concepts in real-world scenarios, they do not need to be rigidly tied to domains, like variables in an SDTM domain do. In fact, in many cases even simple biomedical concepts cannot be bound to one existing domain. As such, Biomedical Concepts in SHARE will support the electronic capture and exchange of biomedical data in a more intuitive way than ever before.
What’s next for Biomedical Concepts in SHARE?
Biomedical Concepts have been created for Foundational Standards as well as numerous TA Standards. Beginning in late 2016, these Biomedical Concepts will be prioritized and slated for loading into SHARE over the months that follow. In parallel, CDISC is piloting a collaboration with clinical community concept models from HL7’s CIMI (Clinical Information Modeling Initiative) team and others to link clinical care and research standards in support of a learning health environment.