Standardized Collection and Submission of Cardiovascular Endpoint Data



Rebecca Wilgus

by Rebecca Wilgus

Building on an FDA writing group chaired by Karen A. Hicks, MD a multidisciplinary expert panel convened in 2011 to standardize cardiovascular endpoints (such as death and MI) to achieve computational interoperability. Representatives from the DCRI, ACC, and CDISC partnered to harmonize clinical definitions, represent the terms in UML and the CDISC Study Data Tabulation Model, and create a demonstration test dataset. Sponsored by FDA grant 1R24FD004411-01, James E. Tcheng, MD (PI) and David Kong, MD (Co-PI) led this project. Robert Anderson, James Topping, Rebecca Wilgus, and Brian McCourt (DCRI), Maria Isler (ACC), and Steve Kopko and Amy Palmer (CDISC) completed the project team.

Next steps include publication of a CDISC Cardiovascular Therapeutic Area User Guide and an ACC-AHA Task Force on Clinical Data Standards manuscript. Future goals include publication as a controlled terminology in the NCI Thesaurus and balloting through HL7 in a future version of the CV Domain Analysis Model.