Table 2.

Kidney Health Initiative (KHI) objectives

1. Facilitate dialogue and research that informs regulatory processes with regard to the kidney health of patients being treated for kidney-related and other diseases.
2. Assess current medical therapies and diagnostics to identify areas in need of greater innovation and/or better-defined regulatory pathways.
3. Develop innovative and efficient trial designs appropriate to answer the most important questions related to kidney health.
4. Establish expert consensus around common terminology and key definitions related to kidney health.
5. Develop approaches to the systematic collection of retrospective or prospective data, such as registries and/or global databases, and establish data standards.
6. 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.
7. Create transparent infrastructure and processes that facilitate collaboration and communication among the greater nephrology community and US Food and Drug Administration (FDA).
 Seek input from all stakeholders (including the FDA, industry, nephrologists and other health professionals, the public or patient groups, the National Institutes of Health, the Centers for Medicare and Medicaid Services, the Health Resources and Services Administration, and other federal agencies).
 Leverage previously conducted and ongoing clinical studies, research infrastructure, and databases.
 Create an open and efficient mechanism for encouraging and evaluating potential projects submitted to the KHI and ensuring objective evaluation.
 Involve consortium members in the selection and execution of projects.
8. Establish systems to optimize postmarket surveillance of products that affect kidney health, either intentionally or by adverse drug reactions.
9. Draft white papers regarding key issues, describing opportunities and challenges, and proposing solutions as well as promoting execution of these solutions.