Data Harmonization in Kidney Transplantation

Abstract

Lack of data standards for nephrology trials can pose particular challenges for investigators/industry/regulators trying to harmonize and compare completed trials. Uniform definitions for datasets are required within many therapeutic areas within nephrology and the US Food and Drug Administration (FDA) targeted solid organ transplant (specifically kidney) as a high priority. This project developed data standards within kidney transplantation alongside the CDISC and CFAST and utilized a similar process to an ongoing project creating standards for diabetic kidney disease. 

Patient Care Issue

Currently, there are over 90,000 individuals waiting for a kidney transplant, with over 80% of those on the waiting list are on dialysis. On average, an individual's life expectancy can double after they receive a kidney transplant.

Challenge

There is a lack of consensus for not only clinical trial endpoints in this area, but also for established standards for clinical research data collection, in order to support the acquisition, exchange, and comparisons of future trials.

Solution

In coordination with the Clinical Data Interchange Standards Consortium (CDISC), Coalition for Accelerating Standards and Therapies (CFAST), FDA, and TransCelerate BioPharma, Inc., KHI assembled a workgroup to partner with these groups and helped define appropriate standards in the therapeutic area of kidney transplant.