Evidence from 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, in Applied Clinical Trials. Four patients from an AstraZeneca-sponsored phase 3 oncology study were enrolled into a live mirror study; and data from the first 5 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.

Transferring mapped data using Archer clearly showed time savings compared to manual methods. These time savings were achieved even with the extra steps taken for manual lookups in verifying data accuracy – a step that would be automated in a real trial setting.  In addition, Archer could significantly reduce Source Data Verification (SDV) and query resolution time in a live study – a factor not considered here.

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.”

IgniteData’s data transfer technology is unique in offering a sophisticated mapping engine, purpose-designed to tackle the specific complexities of healthcare ontologies. The enterprise-level solution combines system-agnostic interoperability between EHR and research systems with speed of data transfer and accuracy of data mapped. Archer stores no clinical data and provides a live step-by-step review and approval process, so data ownership and control are never compromised.

UCLH Director of Research Prof Bryan Williams added: “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.

“The results published today are encouraging for the future of research using data. They streamline the delivery of research, and importantly, the way this technology works means that hospitals can maintain control over the data.”

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. Our data transfer technology successfully mapped 100% of the data for Vital Signs and Labs, and showed potential data transcription errors could be eliminated, paving the way for huge time-savings, reduced SDV, and better use of precious research resources in the future.”

IgniteData’s mapping analysis found that the 15% of forms mapped by Archer accounted for 45% of all study data. Including Unscheduled Visits in future will increase this further. Overall, 96% of the targeted fields for the selected data domains of the Case Report Form (CRF) – Vital Signs, Labs and ConMeds –  were mapped.

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

About UCLH

UCLH (University College London Hospitals NHS Foundation Trust) provides first-class acute and specialist services in five hospitals in North Central London. UCLH is committed to education and research and forms part of UCLPartners which in March 2009 was officially designated as one of the UK’s first academic health science centres by the Department of Health. UCLH works closely with UCL, translating research into treatments for patients. Please see our website www.uclh.nhs.uk for more information, we are also on Facebook (UCLHNHS), Twitter (@uclh), Youtube (UCLHvideo) and instagram (@uclh). UCLH uses the Epic comprehensive electronic health record, and this work was supported by UCLH’s in-house Epic support team.

About IgniteData

IgniteData is transforming the future of clinical trials through its cloud-based Virtual Research Assistant, Archer. A system-agnostic solution, Archer brings modern interoperability between EHR and key research applications, such as EDC. Providing seamless, secure transfer of clinical data, Archer is the global EHR-to-EDC solution for modern clinical trials.

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Dr Nick McNally

Managing Director

UCL/UCLH Research

Prof Bryan Williams

Director of Research

UCLH

Dan Hydes

CEO

IgniteData