Biofourmis, a Singapore-based biotech company, in collaboration with the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI) will capture patient-centric endpoints from discharged patients on BiovitalsHF, a software platform and mobile application hosting health analytics data.
CERSI is a research collaboration between Yale University, Mayo Clinic, and the US Food and Drug Administration (FDA) aiming to advance the regulatory agency’s clinical and post-market surveillance of drugs.
During the study, which will begin in August, patients will be monitored for 60 days via two wearable biosensors: Everion, a medical-grade device designed by Biovotion, and the consumer Apple Watch Series 4.
The sensors will monitor physiology and actigraphy data, including heart rate, blood oxygenation, skin temperature, skin blood perfusion, respiration rate, steps, sleep, and sweat.
Concurrently, the BiovitalsHF mobile application will captureing electronic patient-reported outcomes (ePROs), such as medication adherence, symptoms, as well as results of a guided mobile-based 2-minute-step-test and results from the Kansas City Cardiomyopathy Questionnaire (KCCQ), a questionnaire filled in by patients regarding their symptoms.
Researchers will then try to measure the correlation between the data recorded by the sensors through the wearable technology and the data provided by patients on the BiovitalsHF mobile application, and evaluate them in comparison to lab test results.
Through the results of the study, the partners expect to enable the evaluation of heart failure drugs’ efficacy, in terms of the patients’ quality of life and potentially advance the clinical trial design.
Kuldeep Singh Rajput, CEO of Biofourmis, noted that heart failure significantly lowers a patient's quality of life and that patients' levels of satisfaction and well-being while being treated with a heart failure drug during a trial “should be taken into consideration.”
“Ultimately, this study could open the door for regulatory agencies to consider including patient-centric endpoints in the drug approval process – which could potentially speed the regulatory approval process," Kuldeep Singh Rajput, CEO of Biofourmishe said in a statement.
He added that heart failure significantly lowers a patient's quality of life and that patients' levels of satisfaction and well-being while being treated with a heart failure drug during a trial “should be taken into consideration.”