FDA, Yale, Mayo Clinic Join Forces to Study Cardiac mHealth Data
Source: ThinkStock By Eric Wicklund • Date July 17, 2019
The US Food and Drug Administration is partnering with Yale University and the Mayo Clinic on research into whether a remote patient monitoring platform using mHealth wearables can improve clinical trials that track medication adherence.
The three organizations will launch a Center of Excellence in Regulatory Science and Innovation (CERSI) partnership to monitor recently discharged heart failure patients at home through the Apple Watch and Biovotion Everion wearable.
The project aims to determine whether patient-centered data gathered from digital health devices should be a more central part of research and – eventually – care management for people with cardiac issues. mHealth and telehealth advocates have often argued that these platforms gather information that can greatly improve how healthcare providers plan and treat patients.
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“This joint project has the potential to advance the science of clinical trial design,” Kuldeep Singh Rajput, CEO of Biofourmis, whose mHealth platform will be used in the study, said in a press release. “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.”
“Heart failure is a highly prevalent disease that not only carries high morbidity, but also significantly lowers a patient’s quality of life,” Rajput added. “While hard outcomes such as mortality and hospitalization 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.”
The multi-center study will officially launch in August and span 60 days, during which participants will be monitored at home through the RPM platform. That platform will continuously collect physiology biomarkers and activity.
“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 (6MWT),” officials said. “The data also will be used to assess medication adherence, dose changes and percentage of patients on target dosages of Guideline Directed Heart Failure Therapies.”