title: Overcoming Barriers in Kidney Health-Forging a Platform for Innovation.
abstract: Innovation in kidney diseases is not commensurate with the effect of these diseases on human health and mortality or innovation in other key therapeutic areas. A primary cause of the dearth in innovation is that kidney diseases disproportionately affect a demographic that is largely disenfranchised, lacking sufficient advocacy, public attention, and funding. A secondary and likely consequent cause is that the existing infrastructure supporting nephrology research pales in comparison with those for other internal medicine specialties, especially cardiology and oncology. Citing such inequities, however, is not enough. Changing the status quo will require a coordinated effort to identify and redress the existing deficits. Specifically, these deficits relate to the need to further develop and improve the following: understanding of the disease mechanisms and pathophysiology, patient engagement and activism, clinical trial infrastructure, and investigational clinical trial designs as well as coordinated efforts among critical stakeholders. This paper identifies potential solutions to these barriers, some of which are already underway through the Kidney Health Initiative. The Kidney Health Initiative is unique and will serve as a current and future platform from which to overcome these barriers to innovation in nephrology.
authors.affiliation: AbbVie, Inc., Global Pharmaceutical Research and Development, North Chicago, Illinois; peter.linde@abbvie.com ronald_falk@med.unc.edu.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Linde
authors.affiliation: Center for Drug Evaluation and Research, Office of Medical Policy and.
authors.forename: Patrick
authors.initials: P
authors.lastname: Archdeacon
authors.affiliation: Eli Lilly, Biotechnology Discovery Research, Indianapolis, Indiana;
authors.forename: Matthew D
authors.initials: MD
authors.lastname: Breyer
authors.affiliation: American Society of Nephrology, Washington, DC;
authors.forename: Tod
authors.initials: T
authors.lastname: Ibrahim
authors.affiliation: Quintiles Therapeutic Science and Strategy Unit, San Diego, California;
authors.forename: Jula K
authors.initials: JK
authors.lastname: Inrig
authors.affiliation: Amgen, Inc., Thousand Oaks, California;
authors.forename: Reshma
authors.initials: R
authors.lastname: Kewalramani
authors.affiliation: Vasculitis Foundation, Patient Advisor, Chapel Hill, North Carolina;
authors.forename: Celeste Castillo
authors.initials: CC
authors.lastname: Lee
authors.affiliation: Center for Devices and Radiological Health, Office of Device Evaluation, Division of Reproductive, Gastro-Renal and Urological Devices, US Food and Drug Administration, Silver Spring, Maryland;
authors.forename: Carolyn Y
authors.initials: CY
authors.lastname: Neuland
authors.affiliation: Division of Nephrology, University of Arizona, Tucson, Arizona;
authors.forename: Prabir
authors.initials: P
authors.lastname: Roy-Chaudhury
authors.affiliation: Baxter Healthcare Corporation, Deerfield, Illinois;
authors.forename: James A
authors.initials: JA
authors.lastname: Sloand
authors.affiliation: American Society of Nephrology, Washington, DC;
authors.forename: Rachel
authors.initials: R
authors.lastname: Meyer
authors.affiliation: Center for Clinical Standards and Quality, Centers for Medicare and Medicaid Services, Baltimore, Maryland;
authors.forename: Kimberly A
authors.initials: KA
authors.lastname: Smith
authors.affiliation: American Society of Nephrology, Chicago, Illinois; and.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Snook
authors.affiliation: American Society of Nephrology, Washington, DC;
authors.forename: Melissa
authors.initials: M
authors.lastname: West
authors.affiliation: Division of Nephrology, Department of Medicine, University of North Carolina, Chapel Hill, North Carolina peter.linde@abbvie.com ronald_falk@med.unc.edu.
authors.forename: Ronald J
authors.initials: RJ
authors.lastname: Falk
mesh_terms: D035843:Biomedical Research / Q000458:organization & administration; D002986:Clinical Trials as Topic; D006801:Humans; D007674:Kidney Diseases / Q000175:diagnosis / Q000628:therapy; D009398:Nephrology; D035703:Therapies, Investigational
keywords: Pathophysiology of Renal Disease and Progression; Patient satisfaction; clinical trial; end stage kidney disease; kidney disease