Kidney Health Initiative (KHI)
To advance scientific understanding of the kidney health and patient safety implications of new and existing medical products and to foster development of therapies for diseases that affect the kidney by creating a collaborative environment in which Food and Drug Administration (FDA) and the greater nephrology community can interact to optimize evaluation of drugs, devices, biologics, and food products.
- Facilitate dialogue and research that informs regulatory processes with regard to the kidney health of patients being treated for kidney-related as well as other diseases.
- Assess current medical therapies and diagnostics to identify areas in need of greater innovation and/or better defined regulatory pathways.
- Develop innovative and efficient trial designs appropriate to answer the most important questions related to kidney health.
- Establish expert consensus around common terminology and key definitions related to kidney health.
- Develop approaches to the systematic collection of retrospective or prospective data, such as registries and/or global databases, and establishment of data standards.
- Coordinate "think tanks," public forums, educational exchanges, and other events to promote discussion and updates on topics in kidney health pertaining to drug, device, biologics, and food product development and evaluation.
- Create transparent infrastructure and processes that facilitate collaboration and communication among the greater nephrology community and the FDA, including:
- Seeking input from all stakeholders (including nephrologists and other health professionals, patient groups, industry, the National Institutes of Health, the Centers for Medicare and Medicaid Services, the Health Resources and Services Administration, and other federal agencies).
- Leveraging previously conducted and ongoing clinical studies, research
infrastructure, and databases.
- Creating an open and efficient mechanism for encouraging and objectively evaluating potential projects submitted to KHI.
- Involving consortium members in the selection and execution of projects.
- Establish systems to optimize post-market surveillance of products that affect kidney health, either intentionally or via adverse drug reactions.
- Author journal articles and white papers regarding key issues, describing opportunities and challenges and proposing solutions, as well as promoting execution of these solutions.