KHI Workgroup Opportunity
Data Harmonization in Kidney Transplantation
Overview
There is currently a lack of consensus for not only clinical trial endpoints in transplant, but also for established standards for clinical research data collection, to support the acquisition, exchange, and comparisons of future trials. In coordination with the Clinical Data Interchange Standards Consortium (CDISC), Coalition for Accelerating Standards and Therapies (CFAST), FDA, and TransCelerate BioPharma, Inc., the Kidney Health Initiative (KHI) assembled a working group to partner with these organizations and help define appropriate standards in the therapeutic area of kidney transplant. KHI's specific role was providing clinical and medical expertise. They produced the CDISC Therapeutic Area User Guide for Kidney Transplant (including concept maps, SHARE metadata, SDTM-IG type examples, CDASH annotated CRF examples, and CDASH metadata examples).