This is the News

Welcome to the Exciting World of Pharmacogenomics (pdf)

PGx SDTM Domains Review Package

The completion of the Human Genome Project in 2003 has heralded a new era representing a significant rise in the use of Pharmacogenomic (PGx) data in both research and clinical care.  It promises to be an exciting time to pursue greater understanding of molecular pathways and underlying disease risks in certain populations.  With this increased interest in PGx acting as a catalyst, the FDA started their innovative Voluntary Genomic Data Submission program also known as VGDS.  It recently was extended to also include exploratory data hence the new designation of VxDS. 

The PGx team (a sub-team within the CDISC SDS Team) has developed several domains designed to carry pharmacogenomics data. The development of these CDISC PGx domains was done in parallel  with the work being done by the HL7 Clinical Genomics Work Group, which was initiated jointly several years ago by CDISC and HL7.  Due to their prevalent use in research, the initial design focuses on Genetic Variation and Gene Expression.  

You can read the a full and detailed account of this project here and in the associated package, which includes the domains as well as some helpful PowerPoint presentations.   

CDISC Members are requested to review this package and provide comments on the proposed standard domains by 5 April 2010.   Please forward to others who may be interested in pharmacogenomics within your organizations.