Covance Inc., a global drug development services company, and Frenova Renal Research, a Fresenius Medical Care North America (FMCNA) company, announced a new research collaboration designed to find more effective treatments for patients living with chronic kidney disease (CKD) and end stage renal disease (ESRD).
This collaboration enables Covance to use its powerful analytics capabilities to conduct research on behalf of its biopharmaceutical clients using 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 goal is to improve the lives of kidney patients by looking at which treatments are most effective. 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.
“Health care providers, biopharmaceutical and device companies, patients and payers will all benefit from the pairing of Covance’s analytics expertise and the incredibly rich real-world clinical data collected by Frenova Renal Research. Not only will this better inform treatment and care guidelines, but it has the potential to also inform clinical trial design and drug development,” said Marc Ginsky, vice president and general manager for Covance Market Access Services.
This new collaboration has significant potential to support all key stakeholders, but especially dialysis patients, who undergo intensive treatment three days a week and whose average life expectancy after diagnosis is five years. 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.
“With this unique combination of data and analytics, we can look at how patients actually use medicines day-to-day, which includes the reality of less-than-perfect adherence,” Ginsky said. “We can then explore real-world safety and effectiveness, comparing therapies head-to-head and in the full range of patients, not just those who meet narrow inclusion and exclusion criteria.”
“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, vice president 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.”
As the only Phase 1-4 drug and device clinical development partner dedicated exclusively to renal research, Frenova Renal Research maintains the world’s most extensive database of “de-identified” renal patient data, meaning that any identifying information has been removed in order to protect the privacy of patients.
Date: September 17, 2014