Apple Watch aids FDA mhealth heart failure study
July 23, 2019
A joint effort between Yale University, Mayo Clinic and the US Food & Drug Administration (FDA) is using an mhealth mobile platform from Singapore-based Biofourmis and the Apple Watch to study patients with heart failure.
Biofourmis, a fast-growing specialist in digital therapeutics, has entered a research partnership with the Yale University-Mayo Clinic Center of Excellence in Regulatory Science & Innovation (Cersi). Biofourmis' BiovitalsHF mobile platform will be leveraged in a study of patients with heart failure to monitor functional capacity and quality of life to see if greater emphasis should be placed on these measures in the drug approval process.
"This joint project has the potential to advance the science of clinical trial design," said Kuldeep Singh Rajput, CEO of Biofourmis. "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."
The Yale-Mayo Cersi is a joint effort between Yale University, Mayo Clinic and the FDA. Cersis are collaborations between the FDA and academic institutions to advance regulatory science through research, training and scientific exchanges.
Heart failure afflicts approximately 6.5 million patients in the USA and 26 million worldwide, causing mortality and morbidity, and has major effects on physical function and quality of life. The FDA recognised in a recent draft guidance that an effect on symptoms or physical function, without a favourable effect on survival or risk of hospitalisation, can be a basis for approving drugs to treat heart failure.
"Heart failure is a highly prevalent disease that not only carries high morbidity, but also significantly lowers a patient's quality of life," Rajput said. "While hard outcomes such as mortality and hospitalisation rates have served as the traditional endpoints in clinical studies, we also should take into consideration the patients' levels of satisfaction and well-being while being treated with a heart failure drug during a trial. Not only is quality of life important in a disease such as heart failure, but patient-centric endpoints can be identified much more quickly than traditional hard outcomes."
To demonstrate the feasibility and reliability of capturing these patient-centric endpoints, Biofourmis and Yale-Mayo Cersi will conduct a multicentre study beginning next month of recently discharged patients with heart failure, who will be screened and then monitored at home for 60 days.
Patients will be monitored using BiovitalsHF, which is a sensor-agnostic mobile health platform compatible with clinically validated, FDA cleared and medical CE-marked wearable biosensors. It captures raw biosensor data and uses machine learning to derive dozens of physiology biomarkers and is able to detect heart failure decompensation using multi-variate physiology analytics, weeks in advance.
In this study, BiovitalsHF will be used to capture multiple physiology biomarkers and physical activity continuously in real-world settings, using two wearable biosensors: a medical-grade device called Everion and the Apple Watch series four. Apart from using the BiovitalsHF patient-facing companion app for syncing physiology data from sensors, it will be used to capture electronic patient-reported outcomes (ePros) such as medication adherence, symptoms, the Kansas City Cardiomyopathy Questionnaire (KCCQ) responses, and the guided mobile-based two-minute-step test.
The primary goal of the study is to measure the correlation between physiology and actigraphy biomarkers with clinical endpoints such as lab results, the KCCQ and the six-minute walk test. The data will also be used to assess medication adherence, dose changes and percentage of patients on target dosages of guideline directed heart failure therapies.
"Biofourmis is a leader in the emerging field of digital therapeutics, and we are thrilled to be partnering with them on this important study," said Nilay Shah, principal investigator at the Yale University-Mayo Clinic Cersi. "This study will not only advance science, but will also provide insights to the FDA on how these measures can be used as alternative trial endpoints."
Rajput added: "We have entered into a new era in clinical trial design that encourages patient engagement and values quality of life. By leveraging our user experience, powerful data-analytic capabilities and vendor-agnostic sensor compatibility, we are excited about the prospect that Biofourmis will play a part in establishing new patient-centric endpoints for clinical trials, starting with heart failure."
Biofourmis built Biovitals, a personalised AI-powered health analytics platform that predicts clinical exacerbation in advance before a critical event. This is the backbone of the firm’s digital therapeutics product pipeline across therapeutic areas including heart failure, acute coronary syndrome, COPD and chronic pain.