COVID-19 ushered in a new era of decentralized clinical trials with the ease of collecting endpoints from the home setting. As remote data collection has become a new norm for sponsors, the ability to scale quality control is critical.
NuvoAir, an innovative digital health company that focuses on supporting complex patients, initially targeting respiratory conditions, and ArtiQ, a company bringing artificial intelligence to respiratory medicine, are excited to share news about their partnership to enable automated quality control of spirometry (lung function) data in clinical trials, a process traditionally conducted manually. This collaboration improves the convenience and confidence of at-home and in-clinic spirometry data quality to enable sponsors to further optimize and scale respiratory clinical trials.
NuvoAir’s clinical trial solution enables the collection and integration of multiple endpoints which can be captured from the comfort of patients’ homes via a suite of connected devices (spirometer, inhaler sensor, pulse oximeter, activity tracker and nighttime cough tracker); an integrated patient app; clinician software; and a wrap-around clinical service.
In clinical trials, it is best practice to review the quality of spirometry data using over-reading, a quality assurance process that reviews each test performed to ensure results are in accordance with the American Thoracic Society and European Respiratory Society (ATS/ERS) guidelines for spirometry. With manual over-reading, it can take up to 48 hours before clinical staff and patients can see results.
By integrating ArtiQ.QC, ArtiQ’s software for automatic over-reading based on deep-learning artificial intelligence, patients and clinical staff will receive instant feedback on the quality of spirometry. Clinical staff will be able to make decisions instantaneously during randomization visits, and when patients measure their lung function from home, they will know if they need to perform another test.
“At NuvoAir, the quality of data is high and we are seeing above 89% acceptability of at-home spirometry results with over-reading. We are delighted to partner with ArtiQ, to continue to bring validated and game-changing technologies into respiratory clinical trials and together, set a new standard in spirometry quality control,” shares Furat Shawki, Head of Clinical Trials Product and Operations at NuvoAir.
CEO of ArtiQ, Marko Topalovic said, “This partnership is an important step forward for ArtiQ. It further expands our reach into more clinical trials worldwide and home patient monitoring using our ArtiQ.QC technology. We stay on the mission to empower all stakeholders in respiratory medicine with state-of-the-art AI technology. Most importantly, it simplifies NuvoAir’s over-reading service for spirometry data which allows for the scaling of decentralized, centralized and hybrid clinical trials.”
NuvoAir is a digital health company that focuses on complex patients, initially targeting respiratory conditions. NuvoAir offers a virtual-first clinical service solution that delivers continuous, proactive care by combining best-in-class remote monitoring technology with proprietary biomarkers, deep clinical expertise, and a data-driven infrastructure. Care coordinators and coaches from NuvoAir work in close collaboration with both patients and the care infrastructure of risk-bearing partners to integrate NuvoAir’s technology and data to enable personalized care for each member. NuvoAir’s patient-centric approach also underlies its clinical trial solution. By bringing the trial to the patient’s home, NuvoAir can dramatically improve their experience, reducing the burden for both patients and study sites. More information can be found at www.nuvoair.com.
ArtiQ is a young, dynamic, and innovative spin-off company of the University of Leuven (Belgium). As a medical software company, ArtiQ is dedicated to improve how patients with respiratory complaints are diagnosed & monitored, and how pharmaceutical companies run & optimize respiratory clinical trials. ArtiQ builds and sells smart software to empower traditional respiratory devices and processes. Since 2019, together with researchers, clinicians, equipment manufacturers and pharmaceutical companies we aim to make key improvements for patients with lung diseases. More information can be found at www.artiq.eu.