I use the word "data" more than two dozen times in this post. If you’re a data nerd, I’ve already captured your interest. If you’re not, perhaps saving staff time, reducing costs, and increasing accuracy are topics that pique your interest? Either way, I recommend you read on!

One of the key goals outlined in the SWOG Statistics and Data Management Center’s (SDMC’s) most recent NCTN grant application was to evaluate strategies for collecting patient data from electronic medical records (EMRs). I’m happy to report they’ve made considerable progress toward this goal.

Since 2019, they’ve been working on a pilot project to directly transfer data from EMR systems into the Medidata Rave electronic data capture system we use for our trials. They’ve partnered with the company nCoup and are using that organization’s nCartes cloud software platform to make this happen.

The nCartes platform is optimized to capture structured data – lab results, medications data, and the like. It can, though, also capture and import unstructured data, such as information from progress notes. During the SWOG pilot, it has shown itself capable of automatically pulling data from a high percentage of fields required for our electronic case report forms.

The system doesn’t fully automate the transfer of all data, and it’s in no way meant to replace the expertise of clinical research associates and nurse oncologists who complete electronic case forms for our studies. But for data elements that are easily defined, it speeds up data transfer and allows these professionals to apply their expertise to confirming the transferred data are correct and complete rather than spending their valuable time entering data that are available in the EMR. 

SWOG and nCoup began discussing a collaboration in 2019 and signed a pilot project agreement in the spring of 2020. For this pilot, four initial studies have been configured for data transfer with the nCartes system: S1802 (prostate cancer), S1803 (myeloma), S1826 (lymphoma), and S1827 (lung). Four more studies across multiple disease sites, including one from the NCORP program, have tentatively been selected to be added next.

Three SWOG member sites – to whom we’re most grateful! – have served as initial leads on the pilot:

  • University of California–Davis Comprehensive Cancer Center
  • University of Kansas Cancer Center (which led a previous pilot run with the nCartes platform)
  • University of Rochester Wilmot Cancer Institute

We’re now looking for additional SWOG sites to join this pilot, which has brought two primary benefits to the initial group of sites:

  • reducing data entry time by speeding – or eliminating – the entry of data from the EMR
  • increasing data accuracy by reducing opportunities for data entry errors

Each pilot site has firewall-protected cloud access to nCartes, so sensitive patient health information remains secure, and the site controls what data are pushed from nCartes to Rave. 

nCartes also generates audit logs that show the linkages between EMR source data and the data passed to Rave, which may speed up auditing processes. Audit work for imported numeric data, such as lab data, is also likely to be reduced. 

nCartes supports HL7 or HL7 FHIR data standards, and a single set of EMR system connectors at a site supports any number of trials. nCoup also offers a service for investigator-initiated trials that leverages the same connectors, so sites can make further use of the platform with minimal additional effort. 

New NCTN or NCORP pilot sites will need to make an initial investment to complete paperwork and to install the EMR system connectors, but we expect their return on investment to be highly favorable. Sites currently in the pilot are expecting substantial returns from savings in data entry time alone.

You can find additional details on this SWOG–nCartes pilot collaboration, and initial results, in a poster that Chris Cook, CRAB’s application development director, presented earlier this month at the 2022 Society for Clinical Trials (SCT) meeting.

If something I’ve written above – about time, costs, data accuracy, or just data itself – has piqued your interest in adding your site to the SWOG–nCartes pilot project, please contact the project team at SWOG-EMR-to-EDC@crab.org to learn more.