The therapeutic areas are prioritized through the CFAST Therapeutic Area Program Steering Committee with scientific input from the CFAST Scientific Advisory Committee. These groups include representatives of the major stakeholders, which have brought significant resources and expertise to progress CFAST.


To make the standards electronically accessible and to ensure coordination among all TA standards development activities, CDISC will launch a Shared Health and Research Electronic Library (CDISC SHARE) at the International Interchange in November 2013, and the first release should be ready by Q1 2014. An explanatory video on SHARE is available for more information on this tool, which will benefit from widespread support.


The promise of data standards after PDUFA is in streamlining the entire research process, from protocol through analysis and reporting. Using standards from the start in therapeutic area research facilitates aggregation of results data. An example is C-Path’s Alzheimer’s database with data from over 6,000 patients, which researchers can use in modeling activities to support research for new and better therapies.


FDA has indicated, in a recent position statement, that they will publish guidance in the near future that will require study data in conformance with CDISC standards.


Strength through Collaboration


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