Electronic health records (EHRs) are an essential source of data for our clinical trials. But manually transferring lab results, progress notes, medication lists, and other data from the EHR to our electronic data capture (EDC) system is time-consuming, and every manual transfer introduces the possibility of error.

For more than a decade, SWOG has been working to find a way for sites to access these EHR data more efficiently, while also improving data quality. 

In May of 2022, I wrote of our pilot project with cloud software provider nCartes, Inc., developing and implementing an EHR-to-EDC solution to make this data transfer process more efficient for our member sites.

In this SWOG-nCartes system, data from the EHR are automatically fed to the nCartes software, reviewed by study coordinators at the site, then directly passed to case report forms in the Medidata Rave EDC software.

Following our successful pilot of the nCartes system with four initial studies, we now have it available with ten SWOG trials, across a variety of disease sites and settings:

  • S1703 (cancer care delivery & breast cancer)
  • S1802 (prostate cancer)
  • S1803 (myeloma)
  • S1826 (lymphoma)
  • S1827 (lung cancer)
  • S1918 (lymphoma)
  • S1925 (leukemia)
  • S1931 (renal cancer)
  • S2013 I-CHECKIT (symptom control & quality of life)
  • S2200 (renal cancer)

To date, the solution has accelerated data capture for more than 100 patients, and the project team at SWOG’s Statistics and Data Management Center recently completed an in-depth analysis of nCartes system use. They found the time savings and improved data accuracy were compelling, and they’ll soon submit their analysis to a peer-reviewed journal.

Even before that, though, the team will demo the nCartes system for you, share their insights, and answer your questions in a one-hour webinar, on Thursday, February 29th, starting at 11 am PT / 2 pm ET. Staff from sites currently using nCartes will also be on hand to field questions. Lead oncology research professionals are particularly encouraged to attend (you may want to bring your compliance officer). Register now to get it on your calendar.

I want to express my deep appreciation, on behalf of the project team, to staff at these SWOG member sites that were early adopters:

  • University of California–Davis Comprehensive Cancer Center
  • University of Kansas Cancer Center
  • University of Rochester Wilmot Cancer Institute
  • Oregon Health & Science University
  • University of Texas Health Science Center at San Antonio

Additional sites are rolling out the system and still others are completing their onboarding paperwork. The SWOG-nCartes system is available for use by SWOG sites enrolling patients to any of the ten trials listed above. Learn more at the project team’s Leap Day webinar. Or contact them directly at SWOG-EMR-to-EDC@crab.org.

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Trial of the Week

S1905: A Phase I/II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients with Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)/T-Cell Lymphoblastic Lymphoma (T-LBL)

S1905 is once again enrolling patients.

Since its activation in 2020, this phase I/II study has twice closed to accrual temporarily, but enrollment was restarted, at dose level 3, in fall of 2023. 

If your site has not opened S1905, or if it opened it but has had it on hold because of pauses in accrual, now is the time to revisit the trial and ensure your investigators know it is actively enrolling. 

S1905 is evaluating OBI-3424 – a prodrug that is activated by AKR1C3 – in treating patients with relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. These patients typically face a poor prognosis, and new therapies are needed.

S1905 was activated in August of 2020, has been opened at more than 100 sites, and has accrued 14 patients to date toward its goal of 64 patients.

Study chairs are Anjali S. Advani, MD, who is vice chair of SWOG’s leukemia committee, and Nikolaos Papadantonakis, MD, MSc, PhD.

Learn more on the SWOG S1905 page or the CTSU S1905 page. 

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