ERT has launched two new products in its At-Home Respiratory Solutions line. The technology enables investigative sites to continue with respiratory clinical trials by collecting high-quality spirometry data during home visits.
In the face of the global pandemic, sites are faced with shutdown, and trial participants are reluctant to travel. ERT’s MasterScope and SpiroSphere enable trials involving respiratory ailments to continue with portable, battery-powered equipment that facilitates clinician-administered spirometry assessments outside the site.
Decentralized benefits
Jim Corrigan, president and CEO of ERT, told Outsourcing-Pharma that even with the COVID-19 pandemic causing unprecedented disruptions, decentralized trials can empower sites and sponsors to continue trials while reducing costs, improving engagement and accelerating clinical development.
“By enabling patients and sites to participate in trials virtually and reducing their burden, sponsors can eliminate barriers to study participation that have historically driven up costs and delayed study timelines,” Corrigan said. “A thoughtful decentralization strategy can drive efficiencies throughout clinical development and the lifecycle of a clinical trial.”
Unique challenges
Achim Schülke, ERT’s executive vice president of respiratory solutions, added that while each trial is complex, respiratory trials face can face a number of unique challenges.
“There are a number of considerations to support spirometry and related assessments that would normally be conducted in-clinic by site users in a remote capacity at a patient’s home or other location when a scheduled site visit cannot occur,” he said. “Quality spirometry data can be collected in such scenarios when a trained healthcare professional such as a site user or home nurse travels to the patient with study devices and consumables."
Additionally, Schülke told us, while much decentralized trial technology tends to be operated by the patient with no additional help, for respiratory trials, the assistance of a trained healthcare professional is critical.
“Live, in-person coaching by a trained user is critical for patients to perform proper maneuvers for precise and repeatable data,” he said. “It is recommended to use the same standardized device across a study, regardless of whether data is collected in-clinic or remotely, to reduce variability and improve data integrity.”
Schülke also said hygiene is another important consideration, and the presence of a trained professional can help ensure overall cleanliness and safety.
Data quality
According to Corrigan, data quality and integrity is a high priority.
“We’re pleased to offer options that deliver reliable data ─ regardless of where it is captured ─ so our customers can continue their important development programs, while enabling patients to follow local stay-home mandates and remain safe during the global COVID-19 pandemic," he said.
