Could wearable biosensors change the face of clinical trials and shorten a drug’s regulatory journey? That’s what Yale University and the Mayo Clinic are trying to find out, using biosensors and Biofourmis’ mobile health platform.
The partners will study the use of various patient-focused endpoints, including quality of life, alongside the so-called “hard outcomes” such as mortality or rehospitalization rates, which have traditionally served as endpoints in clinical trials. They will monitor patients with heart failure at home for at least two months after being discharged from the hospital.
The study will be run through a collaboration between Yale, the Mayo Clinic and the FDA called a CERSI—a Center of Excellence in Regulatory Science and Innovation—and it will employ Biofourmis’ BiovitalsHF platform as well as the latest Apple Watch and Biovotion’s Everion multisensor wearable.
The Apple Watch and Everion will track nonclinical measures—like steps, sleep and activity, as well as data on heart rate and blood oxygenation—while the BiovitalsHF platform will gather and analyze biosensor data to develop biomarkers for heart failure.
The patients will also use the BiovitalsHF mobile app to report their symptoms and medication, as well as take tests for exercise capacity and the Kansas City Cardiomyopathy Questionnaire, which uses several criteria to assess quality of life.
“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,” Biofourmis said in a statement. The data will also be used to gauge adherence, track dose changes and identify the percentage of patients meeting the targets of guideline-directed heart failure therapies.
The ultimate goal is to explore whether the FDA should place more emphasis on measures of a person's functional capacity and quality of life in its approval processes.
The partnership follows the agency's draft guidance on endpoints for the development of heart failure drugs. The FDA said it wants to “make it clear that an effect on symptoms or physical function, without a favorable effect on survival or risk of hospitalization, can be a basis for approving drugs to treat heart failure.”
Not only are such measures more salient to patients—after all, how patients feel after hospitalization means more to them than the mere fact that they were hospitalized—but that proactive data-gathering could be faster than waiting for a study event to occur.
"This joint project has the potential to advance the science of clinical trial design," said Biofourmis CEO Kuldeep Singh Rajput, in the statement. "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 said. "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."