CDISC Therapeutic Area Standards: Interchange Sessions on Implementation and Embracing Change for Patients
The Coalition for Accelerating Standards and Therapies (CFAST) was launched as a partnership between CDISC and the Critical Path Institute and now includes governance by a CFAST TA Steering Committee and a CFAST Scientific Advisory Committee with numerous project teams developing standards in various therapeutic areas. Collaborators (in addition to C-Path and CDISC) include FDA, NIH/NCI, TransCelerate, IMI and ACRO as well as many others representing patients, clinicians and researchers in the specific therapeutic areas (please see the CDISC website for additional information on CFAST).
The initial work on therapeutic area standards began with two NIH Roadmap projects, working with Duke Clinical Research Institute, on Tuberculosis and Cardiovascular standards. Another early project was conducted through the Critical Path Institute’s Alzheimer’s disease project and their Coalition Against Major Diseases, which Dr. Martha Brumfield discussed in her keynote presentation. In addition, the SDTM oncology team has developed domains to hold information about solid tumors. These domains are being included in the current breast cancer project and will be re-used in the prostate cancer project scheduled to begin in early 2014.
Much has happened since these early Therapeutic Area (TA) projects. In particular, CDISC has revised the process for developing CDISC TA standards in order to better manage and scale-up the number of CFAST TA projects. In an effort to track progress and improve development processes, the CFAST program held its 2nd annual face-to-face on Friday, 14 November, to review progress and metrics from the first seven TA projects that have been managed under the revised process and to discuss areas where further improvement and efficiencies could be achieved.
Supporting and highlighting efforts around TA standards, this year’s International Interchange included two sessions that focused on TA standards development and implementation, Session 9: Implementation of Therapeutic Area Standards and Session 11: Embracing Change for Patients.
Strength through Collaboration
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