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FDA Workshop (Food and Drug Administration, USA)

United States Last Updated:June 18, 2020
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About Initiative

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In September 2010, NKF and the FDA co-hosted a workshop inclusive of kidney patients to discuss patient reported outcomes (PRO). Initiative Goals One conclusion of the workshop was that more research was needed to determine appropriate PROs for nephrotic syndrome, anemia secondary to kidney disease, and autosomal dominant polycystic kidney disease. Workshop participants agreed that qualitative research, such as conducting patient focus groups, patient interviews, and developing tools to permit clinical trials to target symptom burden associated with the disease state is important in evaluating the benefit to patients of a particular therapy.

Initiative Purpose

Providing guidance to others in their efforts

Time line

Unknown

Conditions

Urology/Chronic kidney disease (CKD)

Research and discovery
Preclinical
Clinical study phase I
Clinical study phase II
Clinical study phase III
Regulatory Review & Approval
Health Technology Assessment (HTA) activities
Post marketing

Organizations (1)

National Kidney Foundation

Patient Advocacy Organization

3 Users
20 Initiatives
2 Resources

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