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Jan 12, 2011

Critical Path Institute and CDISC Extend Data Standards Collaboration

  • Critical Path Institute (C-Path) and Clinical Data Interchange Standards Consortium (CDISC) have entered into a partnership to set new clinical standards that will increase the efficiency of their disease therapy R&D efforts. The agreement was signed at C-Paths’ headquarters in Tucson, Arizona, where CDISC has opened an office adjacent to it in the hopes of optimizing the collaboration.

    Both C-Path and CDISC are focused on establishing precompetitive collaborations to address process gaps responsible for delays and inefficiencies in medical product development. The partnership will take on brain diseases (Huntington disease, ALS, multiple sclerosis), as well as lung cancer, diabetes mellitus, and other diseases identified by the FDA as high-priority public health challenges.

    Previously, the companies collaborated on launching the Alzheimer disease database. Using data standards set by CDISC, C-Path’s Coalition Against Major Diseases combined patient data from eleven clinical trials that were openly shared by seven pharmaceutical companies. The resultant database, launched in June 2010 reportedly provides a standardized platform on which researchers can design efficient trials to test new treatments for patients.

    “To be successful, an enterprise has to establish a common language and tools that facilitate communication and learning,” says Kathleen Sebelius, Secretary of the U.S. Department of Health and Human Services. “The important work being done by C-Path and CDISC is providing scientists around the world with the common data standards and qualified tools critically needed in clinical research and medical product development. The two organizations are natural partners in delivering this important service towards the advancement of public health.”

    The establishment of data standards and better databases will potentially allow the FDA to review new applications more efficiently. Citing the critical importance of data standards, the FDA, in its draft document titled, “CDER Data Standards Plan Version 1.0,” outlines a proposed comprehensive data standards program to be implemented within the agency.

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