CDISC Contact: Andrea Vadakin +1.316.558.0160 avadakin@cdisc.org


CDISC SHARE and CFAST Integrally Linked: A Major Topic at the 2013 CDISC International Interchange


Austin, TX – 10 October 2013 – The Clinical Data Interchange Standards Consortium (CDISC) will prominently feature two of its major initiatives, CDISC SHARE and CFAST, at its flagship event on 4-8 November 2013 in Bethesda, Maryland. Also to be highlighted is the way these initiatives are integrally linked and the way in which they are, in fact, quite synergistic. SHARE will accelerate the development of standards for new Therapeutic Areas (TA) while making all CDISC standards more readily accessible.


The first of these initiatives, the CDISC Shared Health and Clinical Research Electronic Library (SHARE), is a cornerstone of the CDISC technical roadmap, andwill be a global electronic repository for developing, integrating and accessing CDISC metadata standards in electronic format. SHARE is expected to dramatically improve integration among CDISC foundational standards and controlled terminologies, and support greater interoperability with healthcare. The second initiative for which there will be major updates at the Interchange is the Coalition for Accelerating Standards and Therapies (CFAST). A joint initiative of CDISC and the Critical Path Institute (C-Path), CFAST was launched to accelerate clinical research and medical product development by facilitating the establishment and maintenance of data standards, tools and methods for conducting research in therapeutic areas important to public health.


While each of these initiatives has individually gained major press and support in the last year for the benefits they are expected to have upon development of new therapies and public health, it is also essential to understand how these two initiatives are intrinsically linked, each enhancing the success of the other. One of the key messages at the 2013 Interchange will be around how CDISC SHARE works to enable the development of TA standards, which is the purpose of the CFAST initiative.


At this time, there are currently 6 published CDISC TA standards and 6 others in progress. As new TA standards are developed, it is critical to re-use common concepts and SHARE supports such re-use. “For example, the therapeutic area of Diabetes is complicated; this widespread disease involves the cardiovascular system, the nervous system and many other aspects of the body. Therefore, a standard must include cardiovascular concepts such as those that are developed as cardiovascular endpoints for cardiovascular disease,” said Dr. Rebecca Kush, Chair of the CFAST Scientific Advisory Committee and CDISC President. “Imaging concepts or standards will apply to a number of therapeutic areas such as Alzheimer’s Disease and Oncology, and standards for breast cancer will re-use elements CDISC has developed for solid tumors. This is the beauty of having a tool like SHARE, which will expedite the


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