The FDA CDER Data Standards Strategy calls for the development, implementation, and maintenance of comprehensive clinical data standards to facilitate the efficient and effective review of regulatory submissions. For this project, the CFAST founding partners, C-Path and CDISC, will collaborate to perform four specific aims: 1) Maintenance of the scientific and administrative infrastructure of the CFAST public- private partnership to support a series of projects under the CFAST Initiative. 2) Identification and engagement with key experts in specific therapeutic areas, including stakeholders from industry, professional organizations, academia, and government agencies, and coordination and management of therapeutic area standards development projects with those experts. 3) Development of two new therapeutic area data standards for Major Depressive Disorder and Kidney Transplant Products, as well as completing three data standards that are in- process from the previous award (diabetic kidney disease, CV imaging and rheumatoid arthritis). Additionally two new therapeutic area data standards may be started but not completed during the award period (Parkinson's v2.0 and Duchenne Muscular Dystrophy). 4) Identification and implementation of continuous quality improvements with respect to the data standards development process and products to facilitate timely and sustainable standards to include integrating the use of an electronic repository of standards components and metadata early in the development process, i.e. the CDISC Shared Health and Clinical Research Electronic (SHARE) library. CFAST Relevance The FDA Center for Drug Evaluation and Research (CDER) receives an enormous and growing amount of data in a variety of regulatory submissions from a multitude of sources and in a variety of formats. The lack of standardization creates significant challenges to realizing the potential those data have to advance CDER's regulatory and scientific work. Continuing the efforts to establish common standards for data reporting will provide opportunities to transform massive amounts of data from drug studies on specific diseases into useful information to potentially speed the delivery of new therapies to patients.
The FDA Center for Drug Evaluation and Research (CDER) receives an enormous and growing amount of data in a variety of regulatory submissions from a multitude of sources and in a variety of formats. The lack of standardization creates significant challenges to realizing the potential those data have to advance CDER's regulatory and scientific work. Continuing the efforts to establish common standards for clinical data reporting will provide opportunities to transform massive amounts of data from drug studies on specific diseases into useful information to potentially speed the delivery of new therapies to patients.
