NWEH says module cuts side effect reporting burden in trials

Monitoring patient safety is of the utmost importance when running a clinical trial, but recording and reporting side effects can be labour-intensive and costly.

One company trying to make the process more efficient is NWEH, a specialist in software used to manage clinical trials. It has just launched a serious adverse event (SAE) module that it claims can reduce reporting time and the associated costs by up to 70%.

Called SAEfe, the software operates as part of NWEH’s ConneXon electronic data capture (EDC) platform and harvests real-world data directly from electronic health records (EHRs), populating SAE reports directly.

At the same time, other relevant medical conditions and information can be selected and added to the report with no transcription needed, according to the Manchester, UK-based company.

Once a completed SAE report is saved, it is electronically submitted as an individual case safety report (ICSR) directly to the sponsor study database, a process that NWEH says reduces transcription errors that may creep in with manual data entry and allows investigators to redeploy time saved to focus on the wellbeing of trial participants.

Unlike methods that rely on trial participants reporting issues themselves, the ConneXon platform also alerts the research team within 24 hours of an event being recorded in the patient’s EHR, allowing swift action to be taken.

“The use of anonymised EHR data in clinical trials is nothing new anymore,” said Jonathan Wogel, NWEH’s chief executive. “What is new, is using the EHR data to auto-populate the SAE report, saving our customers a significant amount of time and money.”

This kind of remote data-gathering is an important element in decentralised clinical trials (DCTs) and can also help to improve the inclusivity of clinical research.

Established in 2016, NWEH (NorthWest EHealth) grew out of a collaboration between the University of Manchester, Salford Royal Foundation NHS Trust, and Salford Clinical Commissioning Group.

Its technology platform was deployed in the world’s first digitally enhanced, large-scale phase 3 trial to use data directly from source EHRs, which looked at the safety and efficacy of GSK’s Relvar Ellipta (fluticasone furoate/vilanterol) therapy for chronic obstructive pulmonary disease (COPD).

The Salford Lung Study found a higher rate of SAEs compared to traditional trials, which NWEH said “demonstrates the effectiveness of using real-world data sources and innovative technology to significantly enhance patient safety and produce much richer datasets for analysis.”

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