This is the News

Asked to reflect on 2009 as it comes to a close, I have to admit that it has not been an easy year for most. With the downturn in the global economy, we have all been re-evaluating our expenditures and processes with an eye on being more efficient and cost-effective.  This is the perfect time to reap the benefits of standards for data interchange and to transform research processes.  The important thing to remember here is that the greatest value is reaped when standards are implemented in the beginning of a research study or program, as in building quality in up front. 

This year, many thanks to its wonderful volunteers, CDISC made significant progress in completing and ‘teeing up’ certain standards such that we will be going into 2010 with a complete suite of standards for biomedical research, from protocol representation through reporting and analysis.  This standards suite is augmented with interoperability specifications and integration profiles to enable the use of EHRs for research, while adhering to applicable regulations.   We are poised to benefit from the implementation of these transformational initiatives and products.

Specific accomplishments include (but are not limited to):

• The interoperability specification developed through HITSP, which identifies the CDISC IHE Retrieve Form for Data Capture (RFD) integration profile and CDISC CDASH to exchange a core set of research data from EHRs to clinical research systems
• The CDASH Implementation Guide and harmonization of CDASH elements with the NCI standard CRFs and CDEs
• BRIDG Release 3, which is targeted towards not only technology developers and modelers but also domain experts
• The Protocol Representation Model based on BRIDG, which includes the Trial Design Model (TDM) as in SDTM; the Clinical Trial Registration elements; Eligibility Criteria and other elements that are found in all protocols for research studies
• The application of the RFD to improve adverse event reporting (ASTER)
• Genomics augmentations for the LAB model (and coming for SDTM)
• And numerous terminology elements to enhance the interoperability and refinement of the CDISC standards

Additional progress was made in 2009 to pilot and determine how to build and implement SHARE to make the CDISC standards more accessible and identify terminology and value sets for the BRIDG model.  We have enjoyed strength through collaborations, in particular with the NCI and Mayo Clinic who enabled the SHARE pilot and those who contributed content for it (Mayo, MD Anderson, GSK, Lilly and Genzyme).

As this year draws to a close, we are excited to be working with CDER and CBER on a plan focusing on standards implementation, specifically to ‘tighten up’ SDTM and ADaM and to develop the efficacy data elements (which will also be in SHARE).

And, on the global front, we continue to grow, with 60 countries in our participant database and interest from Korea, India and China in solidifying CDISC Coordinating Committees and building Local Expert Groups.   We also continue to participate in the Joint Initiative Council (JIC) for International Harmonization (ISO, HL7, CEN, CDISC and IHTSDO) through which we will be balloting BRIDG in 2010.

On behalf of CDISC, its Board of Directors and Operations, we wish you all a joyous and peaceful holiday season and all the best for the coming New Year 2010.

Dr. Rebecca Kush
CDISC CEO and President