An innovative study of patients with heart failure that will monitor functional capacity and quality of life to see if greater emphasis should be placed on these measures in the drug approval process could “advance the science of clinical trial design,” says Kuldeep Singh Rajput, CEO of Biofourmis. His organization has entered a research partnership with the Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI). Biofourmis’ mobile platform BiovitalsHF will be leveraged in the study.
“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,” Rajput says.
The Yale-Mayo CERSI is a joint effort between Yale University, Mayo Clinic, and the U.S. Food and Drug Administration (FDA). CERSIs are collaborations between FDA and academic institutions to advance regulatory science through innovative research, training, and scientific exchanges.
Heart failure afflicts approximately 6.5 million patients in the United States and 26 million worldwide, causing substantial mortality and morbidity, and has major effects on physical function and quality of life. In a recent guidance, “Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry,” the FDA notes 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.
“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,” Rajput says. “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 new patient-centric endpoints, Biofourmis and Yale-Mayo CERSI will conduct the multicenter study beginning next month (August) on recently discharged patients with heart failure, who will be screened and then monitored at home for 60 days.
“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,” adds Nilay Shah, PhD, principal investigator at the Yale University-Mayo Clinic CERSI.
Edited by Michael Causey