ERT, a global data and technology company that captures critical endpoint data while minimizing uncertainty and risk in clinical trials, announced multiple options that enable trained healthcare professionals to advance respiratory clinical trials by collecting high-quality spirometry data during patient home visits. ERT’s At-Home Respiratory Solutions enable clinical trial sponsors to continue developing new respiratory treatments while patient access to investigative sites is limited due to COVID-19 stay-at-home mandates.
Sponsors are looking for innovative virtual study continuity methods that enable them to evaluate the safety and efficacy of new medical treatments without requiring patients to attend investigative site appointments. Precise, repeatable spirometry data can be collected when trained healthcare professionals use study devices in patients’ homes and provide coaching on how to perform the proper breathing maneuvers.
ERT MasterScope and SpiroSpheremeet these needs by enabling clinician-administered spirometry assessment during patient home visits. The portable, battery-powered solutions provide clear, real-time quality feedback to obtain high-quality spirometry readings from patients and transfer data to the ERT Portal directly from patients’ homes. Additional integrated devices enable trained users to capture ECG, FeNO and Forced Oscillometry data with MasterScope. The at-home approach can be added to currently active studies.
“To reduce variability and improve data integrity, sponsors are recommended to use the same standardized device across a study, irrespective of whether data is collected in-clinic or remotely,” said Achim SchÃ¼lke, Executive Vice President of Respiratory Solutions at ERT. “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.”