ERT Introduces Compliant Respiratory Solution

July 23, 2020

Applied Clinical Trials

ERT has announced it has significantly enhanced its spirometry data collection systems to capture more accurate, research-grade lung function data to support the development of new respiratory treatments and documenting of disease progression. These enhancements make the respiratory solution achieve full compliance with standards issued by the American Thoracic Society and European Research Society (ATS / ERS) in 2019.

Historically, high levels of spirometry data variability were considered to be acceptable in clinical trials, potentially obscuring true treatment effects and leading to prolonged development timelines and increased costs in respiratory drug development. As a result, in 2019 ATS/ERS issued new standards for manufacturers, clinicians, operators, and researchers with the aim of increasing the accuracy, precision, and quality of spirometric measurements and improving the patient experience.

We’re pleased to add the industry’s first complete ATS/ERS 2019-compliant respiratory solution to the long list of innovations ERT has introduced to help our customers bring new treatments to patients sooner,” said Achim Schülke, Executive Vice President, Respiratory Solutions at ERT. “Clinical trial sponsors can now have confidence in the veracity of their clinical trial data and leverage ERT’s expertise in adapting clinical trial protocols to the new guidelines so that they can further reduce data variability and develop new respiratory treatments more efficiently.”

ERT’s spirometry collection devices and data management solution are configurable to each respiratory trial’s unique protocol, delivering the highest data quality in accordance with these new guidelines, and helping trial sponsors meet other clinical development objectives. 

“The ATS/ERS standards are driving a new era of data quality by reducing the incidence of implausible data and changes in function associated with suboptimal coaching,” said Kevin McCarthy, Member, Proficiency Standards for Pulmonary Function Laboratories Committee, American Thoracic Society and a member of the ATS/ERS Task Force that produced the updated spirometry standards. “Thanks to the new guidelines, sponsors will gain better insight into treatment effects, which will help prioritize their pipelines and focus their development efforts on drug candidates that are the most viable and safe.”

Related Content:

Regulatory