This collaboration pits Covance’s analytics capabilities with Frenova’s database, the world’s largest renal database with longitudinal data on more than 393,000 CKD patients and 980,000 ESRD patients.
The data will be used to better understand the burden of illness, treatment patterns, medication adherence, and comparative safety and efficacy of medical treatments in the real world. The collaboration will also help new drug sponsors assess protocol feasibility, select study sites, conduct targeted patient recruitment and determine optimal sample size.
“By combining this data with our advanced analytics capabilities, led by a team of epidemiologists and biostatisticians, Covance and Frenova can design and execute studies to better understand the burden of illness, treatment patterns, medication adherence, and comparative safety and effectiveness of medical treatments in the real world,” Marc Ginksy, VP and General Manager of Covance Market Access Services, told Outsourcing-Pharma.com. “This collaboration also will help study sponsors assess protocol feasibility, select study sites, conduct targeted patient recruitment, and determine optimal sample size.”
But the research collaboration isn’t directly tied to any recent changes in the CKD or ESRD markets.
Ginsky added: “This collaboration is not a specific reaction to something happening in the nephrology market as much as it is a response to a growing need within the health care industry for taking the vast array of available health care data and turning it into actionable information to improve study designs, make better health care decisions, and lower health care costs.”
The ultimate goal is for the analyses to provide insights into ways of slowing the progression of chronic kidney disease and preventing the need for dialysis for some patients altogether, Covance said.
“This collaboration will help us partner with our biopharmaceutical and device clients to provide insights into ways of slowing the progression of CKD and preventing the need for dialysis for some patients altogether,” Ginsky said.
“After more than 25 years of collecting data, we have more data and more experience working with renal patients than any other organization. We are a vital resource that enables sponsors to start with the patient in mind,” said Kurt Mussina, VP and general manager for Frenova Renal Research. “Combining our data with Covance’s analytics capabilities will provide scientists the opportunity to do research that can lead the way to real breakthroughs in patient care.”
Frenova Renal Research maintains the world’s most extensive database of “de-identified” renal patient data, including clinical data such as comorbid conditions, diabetic status, laboratory results, treatments, and disease stage of more than 393,000 CKD patients in the US, Ginsky said. Frenova’s ESRD database of more than 980,000 patients from a network of dialysis facilities worldwide contains information such as dialysis history, medications, laboratory results, hospitalizations, quality of life, and mortality.