KHI Current Project
Building Capacity to Incorporate Patient Preferences into the Development of Innovative Alternatives to Renal Replacement Therapy (RRT)
Abstract
Accelerated innovation in the kidney community highlights the need for integrating the patient perspective at every step of the product lifecycle. Access to scientifically valid patient preference information could positively inform the decisions of industry and regulators as they design and review new devices for people with kidney failure. This project, a three-year contract with the FDA, seeks to collect patient preference information on innovative renal replacement therapies (RRT). This will help KHI members and the kidney community with the development of safe, effective, and novel RRT devices that target the issues that are important to patients and their care partners. Completing this project is a priority for the federal government, Object 1, Goal 2 of the Advancing American Kidney Health initiative instructs the FDA to "develop a new survey to gain insight into patient preferences for new kidney failure treatments".
Deliverables
To support the FDA and Advancing American Kidney Health's goals, the deliverables of this project are:
- Prioritization of patient's perspective on benefits and risks of innovative RRT devices.
- Inventory of benefit – risk levels for product introductions for innovative RRT devices.
- Results from a pilot study of patient preferences for innovative RRT.
- Publications on best practices and lessons learned from developing the survey. Development of a Patient Preference Survey for Wearable Kidney Replacement Therapy Devices
Approach
The project is directed by a Steering Committee including people with kidney disease as patient partners.
Steering Committee
Co-chairs
- Jennifer E. Flythe, MD, MPH, FASN, University of North Carolina Kidney Center at Chapel Hill
- Michelle Tarver, MD, PhD, FDA
- Allen Chen, PhD, FDA
- Derek Forfang, Patient Advisor
- David Gebben, PhD, FDA
- Gema Gonzalez, FDA
- Raymond C. Harris, MD, FASN, Vanderbilt University
- Frank Hurst, MD, FDA
- Carolyn Neuland, PhD, FDA
- Anindita Saha, FDA
- Kien Wei Sai, MIT
- Murray Sheldon, MD, FDA
- Grace Squillaci, KHI
- Melissa West, KHI