Putting patient cardiac safety first through at-home monitoring

Background

While medications are being developed every day that show great promise to improve disease symptoms, pharmaceutical companies cannot bring them to market unless they “first, do no harm.” Negative cardiac effects are especially concerning in drug testing, as they can be difficult to uncover through just a few days of in-clinic patient monitoring.

A digital health lead at a large pharmaceutical company came to HumanFirst with this exact challenge, concerned about the development of cardiac abnormalities in patients treated with one of their therapeutics. Patients would show normal cardiac function in initial assessments, only to return to the clinic at a later visit with cardiac abnormalities. The pharmaceutical team needed to better understand what was happening between those check-ins.

“Digital sensors are one of the keys to the future of clinical research, and HumanFirst are the experts in helping us choose the best-fit options for specific studies.”

- Principal Scientist, Top Ten Pharmaceutical Company

Working with HumanFIrst

The team reached out to HumanFirst with a request for a wearable that could capture continuous cardiac rhythms that could be used to detect QT prolongation, or an issue with the heart muscle taking a longer time to contract and relax than is normal.

They were looking for passive and continuous monitoring with the goal of establishing when these abnormalities were occurring in the timeframe between initial and the next scheduled patient evaluations.

Continuous cardiac rhythm monitoring is one of 500+ measure categorieson the Atlas data platform. Atlas covers 10,000+ measures and more than2000 digital health technologies.

Results

The team used Atlas Reports to hone in on multi-lead ECGs with evidence to identify cardiac arrhythmias, and specifically, QTc prolongation. Atlas evidence confirmed their hypothesis – a single lead ECG would not be sufficient for this measure. They compared products they had previously used (e.g., BodyGuardian, AliveCor, Zio patch) with products with which they were less familiar (e.g., CAM by Bardy Dianostics, Cor by Peerbridge Health, EPatch by Biotel) to evaluate evidence, tech specs, data rights and security questions side by side. The Atlas platform led the team to make efficient, informed decisions based on all evidence and technology options available.