Clinical and Translational Semantics and Data Standards

Within the scientific research community, there are huge shifts taking place. Basic and clinical research is now focused on the molecular basis for disease and on creating targeted therapies that take into account each patient’s unique biology, often called Precision Medicine. This means understanding the genomic basis for disease, and matching specific, targeted therapies to address them. It also means having the ability to do integrated data analysis – combining information from diverse areas of research and treatment, such as animal models, pre-clinical, proteomics, genomics, and clinical care – in order to make connections between the data that illuminate illness and potential treatments. Traditionally, these areas had no real connection – data analysis happened within each domain, and data was not shared across domains – and this is still true today. The situation cannot remain as it is in order for science to realize the vision and benefits of Precision Medicine. The traditional barriers and boundaries between basic research, clinical research, and clinical treatment must be broken down to allow free data flow and sharing between them.

Essex has led and supported numerous data standards and semantics initiatives. Our Project Managers and Subject Matter Experts have led a nationwide collaborative effort to define and implement Standardized Case Report Forms, composed of Common Data Elements, for federally funded cancer clinical trials. Essex Director, Joe Martucci, is an NIH Award of Merit recipient for his contributions to create both standards for the nomenclature of molecular diagnostics and a database to identify markers in NCI-funded clinical trials in support of Precision Medicine. Our team designs and develops systems which incorporate and implement domain models based on CDISC standards such as the Study Data Tabulation Model (SDTM) and the Biomedical Research Integrated Domain Group (BRIDG); as well as integration and interface approaches which leverage HL7 messaging standards.

Read more about the NCI CRF Harmonization and Standardizationprocess.

Visit the Clinical Data Interchange Standards Consortium (CDISC) web siteto learn about efforts to create standards for clinical data.