Asking people with kidney failure what matters to them is critical for patient centered innovation. If that information can be collected in a scientifically rigorous way, it can inform industry and regulatory decision making.
The Kidney Health Initiative (KHI) is launching a new project in collaboration with the US Food and Drug Administration (FDA) to collect patient preference information on innovative renal replacement therapies (RRT). The three-year project, funded by the FDA, will produce a survey that captures scientifically valid patient preference and risk tolerance data from people with kidney failure to drive innovations in RRT. This information is increasingly important as innovation accelerates in the kidney community. The Advancing American Kidney Health initiative identified this need, directing the FDA to “develop a new survey to gain insight into patient preferences for new kidney failure treatments”.
Asking people with kidney failure what matters to them is critical for patient centered innovation. If that information can be collected in a scientifically rigorous way, it can inform industry and regulatory decision making.
The Kidney Health Initiative (KHI) is launching a new project in collaboration with the US Food and Drug Administration (FDA) to collect patient preference information on innovative renal replacement therapies (RRT). The three-year project, funded by the FDA, will produce a survey that captures scientifically valid patient preference and risk tolerance data from people with kidney failure to drive innovations in RRT. This information is increasingly important as innovation accelerates in the kidney community. The Advancing American Kidney Health initiative identified this need, directing the FDA to “develop a new survey to gain insight into patient preferences for new kidney failure treatments”.
Patient preference surveys have been used successfully in other disease areas to spur innovation. KHI’s project is based on a similar endeavor by the Michael J. Fox Foundation . A patient preference study asks what is most important to people with a disease and measures their responses to various risk/benefit levels. The result of a patient preference study is a set of value-based decisions illustrating tradeoffs between risk and benefits of new technologies. For example, respondents may be asked to rank their priorities and relay how much risk they would except in exchange for a benefit.
The real-world evidence generated from a patient preference survey can be integrated into every aspect of the product lifecycle. New entrants into the kidney disease field can ensure the patient perspective is included throughout their design process. It can be used to drive the development of safe, effective, and novel RRT devices that target the issues that are important to patients and their care partners.
This new project builds off the patient survey completed as part of the KHI’s Technology Roadmap for Innovative Approaches to Renal Replacement Therapy , KHI’s “Patient Reported Outcomes for Novel Renal Devices” project, and the Standardized Outcomes in Nephrology (SONG) initiative’s work. The project is directed by a steering committee that includes people with kidney diseases as “patient partners”. In addition to the survey, the steering committee intends to publish and present the lessons learned and best practices derived from developing the survey.
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