2019 CDISC Interchange Highlights – Clinical Data Standards Are Here To Stay

By Terek Peterson, Vice President, Clinical Analytics and Data Strategies

The 2019 Clinical Data Interchange Standards Consortium (CDISC) Interchange took place on October 14 – 18th in sunny San Diego at the Marriott Waterfront – quite an inspiring place to discuss standards and innovation.  The President and CEO of CDISC, David R. Bobbitt, reminded us that CDISC continues a journey of change that will require clinical data standards to evolve.  This change is being shaped by new sources of data and technology.  “A future where data standardization facilitates good science to help reduce human suffering,” said Mr. Bobbitt.

The conference kicked off with a keynote from Paul Slater, co-founder of the Clinical Research Innovation Hub (CRIH) at Microsoft.  While happy to know that folks are cutting and pasting in MS Word to create protocols, he emphasized the need for an electronic protocol (eProtocol) that would allow for emerging technologies to consume protocol metadata.  In addition, industry should be employing natural language processing to surface research data from existing journals.  There is the need for big ideas to shift technology companies, as risk aversion limits innovation and baby steps will not work.  It was inspiring to hear his call out suggesting research should be using all available data and all patients that would benefit from research projects should be included.  In the future, we may not be talking about electronic data capture (EDC) and clinical trial management systems (CTMS), with research data coming from electronic health records (EHRs) and electronic clinical outcome assessments (eCOA).  Lastly, the use of data lakes and graph database are needed to better connect new data sources.