A collaboration involving the FDA is set to evaluate new endpoints for heart failure clinical trials. The partners will use wearable devices to assess how heart failure patients function and feel after being discharged from hospitals.
Working as part of the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI), the FDA has identified the need for alternative heart failure endpoints. Improving mortality and reducing hospitalizations are gold-standard endpoints for clinical trials, but attempts to demonstrate the efficacy of drugs against those yardsticks are confounded by factors including the variability of the patient population.
A who’s who of major drug developers including Abbott, Bayer, Genentech, Novartis and Merck have come unstuck when trying to show safety and efficacy in phase 2 and 3 heart failure trials over the years, resulting in significant, ongoing unmet medical needs.
Yet, mortality and hospitalizations are far from the only important things to heart failure patients. As these patients have substantially reduced functional capacity and quality of life, there is scope for drugs to demonstrate their worth in the population in other ways, provided researchers can gather accurate, reliable data to measure these changes.
Recognizing that, CERSI, in collaboration with Biofourmis, plans to assess the use of wearable devices to capture data on endpoints that are complementary to the mortality and hospitalization measures in use today.
Starting next month, the partners will track heart failure patients for 60 days after they are discharged using Apple Watch and Biovotion’s Everion wearable. These devices will feed data into Biofourmis' BiovitalsHF, a platform that crunches sensor data to derive physiology biomarkers and detect heart failure decompensation. Biofourmis will also provide a smartphone app that enables the capture of electronic patient-reported outcomes and helps patients perform a two-minute step test.
By capturing and analyzing the data, the partners hope to show how physiology and actigraphy biomarkers correlate with clinical endpoints including the six-minute walk test. In doing so, the study could suggest new ways to assess the efficacy of heart failure drugs.
"This joint project has the potential to advance the science of clinical trial design," Biofourmis CEO Kuldeep Singh Rajput said in a 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."