Electronic Health Records-to-Electronic Data Capture Live Pilot Study

University College London Hospitals NHS Foundation Trust (UCLH), IgniteData and AstraZeneca have evaluated how Electronic Health Records (EHR) to Electronic Data Capture (EDC) data transfer could perform in a clinical trial setting. Four patients from an AstraZeneca-sponsored Phase III oncology study were enrolled into a live mirror study; and data from the first five of their visits were electronically transferred from UCLH’s EHR to a copy of the study database. In scope were three data intensive, structured domains: Vital Signs, Labs and Concomitant Medications. The live pilot found that IgniteData’s data transfer technology, Archer, could map 100% of Vital Signs and Labs data, and was able to successfully transfer 100% of mapped data from these domains.

IgniteData’s Archer enterprise-level solution combines system-agnostic interoperability between EHR and research systems. Archer stores no clinical data and provides a step-by-step review and approval process, so data ownership and control are not compromised.

HCP experience was measured using a 7-Lickert scale questionnaire: for user experience and perceived reduction in site burden, the overall score was positive and UCLH is optimistic about the future of EHR-to-EDC data transfer.

Dr Nick McNally, Managing Director, UCL/UCLH Research, said: “Evidence from our collaboration with IgniteData and AstraZeneca shows that laborious manual data transcription methods might realistically become a thing of the past as we see clear advances in data transfer technology. The UCLH team found Archer to be intuitive and easy to use. We were up and running after a short but comprehensive training session – exactly as we hoped.”

UCLH Director of Research Prof Bryan Williams added in a press release: “These are important results from a very successful pilot. The study highlights the value of having digital data in an EHR, which can then be rapidly transferred in a semi-automated way to other research systems.”

Dan Hydes, CEO at IgniteData, remarked, “IgniteData is extremely proud to have been selected as the technology vendor of choice for this collaboration with UCLH and AstraZeneca.”

The insights gained from this pilot study will inform ongoing collaborative plans to optimize CRF design, explore medical coding of EHR medications, and expand the use of EHR-to-EDC technology across various domains.

Reference: Evidence from Electronic Health Records-to-Electronic Data Capture live pilot study.Maidenhead UK, July 25, 2023.