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CFAST Launches Two New CDISC Therapeutic Area Standards
Jan 29 14
The Clinical Data Interchange Standards Consortium (CDISC), Critical Path Institute (C-Path) and TransCelerate BioPharma Inc. (TransCelerate) announced that version 1.0 of the Asthma Therapeutic Area (TA) User Guide (UG) and version 2.0 of the Alzheimer's TAUG are now available for implementers on the CDISC website. These user guides and the new standards development process through which they were formed are expected to further accelerate the development of additional TA standards. This is expected to streamline the process of developing new therapies for patients. The release of these two standards marks the first time that TA standards have been fully developed through the CFAST partnership using the enhanced CDISC standards development process. CFAST is a joint initiative of CDISC and C-Path, with partners such as TransCelerate, the U.S. Food and Drug Administration (FDA) and the National Institute of Health's (NIH) National Cancer Institute - Enterprise Vocabulary Services (NCI-EVS), and with participation and input from many other organizations. An aim of the CFAST effort is to support the goals of the FDA's Therapeutic Area Standards (TAS) Initiative Project Plan. Version 2.0 of the Alzheimer's TAUG provides guidance on the implementation of the Study Data Tabulation Model (SDTM) to represent Alzheimer's data in regulatory submissions. This User Guide describes the most common research concepts relevant to studies of Alzheimer's disease and mild cognitive impairment, and gives guidance on the necessary metadata to represent in a way that is consistent with CDISC standards. The goal of this project was to expand upon v1.0, including a broader set of concepts for Alzheimer's clinical trials and research, using the Alzheimer's Disease Neuroimaging Initiative (ADNI) as the primary source of input. Substantive additions from version 1.0 include 10 new clinical scales of cognition/function, cerebrospinal fluid (CSF) biomarkers sample handling and processing, and imaging biomarkers including volumetric MRI, amyloid PET imaging and FDG-PET imaging. It is anticipated that the process followed for the Asthma standard will serve as a model for the development of many more TA standards through the CFAST initiative. The Asthma TA data standard specifically includes variables being collected in clinical research studies in support of therapies for asthma in adults.
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