Development of Standards Aid FDA in Meeting Commitments under PDUFA V

Tucson, AZ, 6 November 2013 —The FDA has awarded a two-year, $2 million grant to Critical Path Institute for its joint initiative with the Clinical Data Interchange Standards Consortium (CDISC) to strengthen the framework and further the objectives of the Coalition for Accelerating Standards and Therapies, known as CFAST. The grant comes as part of FDA efforts to support the development of new data standards needed to streamline the process for evaluation and approvals of new medical products.


CFAST is focused on developing data standards, tools and methods for conducting research in therapeutic areas that are important to public health.


The common CDISC standards developed through a collaborative process provide a consistent way to collect and submit clinical trial data, allowing researchers, drug developers and regulatory agencies to aggregate and analyze clinical data more efficiently.


“This new FDA grant will enable CFAST to support CDISC’s work in key therapeutic area standards projects that need to be completed in the next two years,” stated Wayne Kubick, CDISC Chief Technical Officer.


Since 2011, the collective work of CDISC and C-Path has resulted in six new therapeutic area standards that are available today for Alzheimer’s disease, pain, Parkinson’s disease, polycystic kidney disease, tuberculosis, and virology. Additional projects are underway to develop standards in areas designated as priority by the FDA.


“This grant and our continuing collaboration will build on the strengths and perspectives we each bring and can aid in expediting drug development and regulatory review through the increased application of clinical data standards” says Enrique Avilès, C-Path Chief Technology Officer.


Approximately half of the current new drug applications to the FDA’s Center for Drug Evaluation and Research are submitted using CDISC standards. The FDA will soon require that submissions conform to CDISC data standards.


Use of data standards is expected to improve the efficiency and quality of the drug review process. The FDA estimates that up to 40 percent of the work in processing a submission is in preparing data for review.


CFAST, through C-Path and CDISC’s combined skill set, along with the work of each organization’s supporters, facilitates faster development of clinical data standards, contributing to more efficient development of safe and effective medical products and a more informed healthcare system.


The announcement of the FDA grant comes in advance of the annual CDISC International Interchange, occurring now through November 8, 2013. The Interchange, taking place in Bethesda, Maryland will highlight major announcements on the progress of CFAST projects, as well as how new therapeutic standards development are intrinsically linked with the rollout of a new CDISC innovation, CDISC SHARE, which will improve access to the standards. For more information on the 2013 CDISC International Interchange, please visit the CDISC website.



CFAST, a joint initiative of CDISC and the Critical Path Institute (C-Path), was launched to accelerate clinical research and medical product development by facilitating the establishment and maintenance of data standards, tools and methods for conducting research in therapeutic areas important to public health. CFAST collaborators include the U.S. Food and Drug Administration (FDA), TransCelerate BioPharma, Inc. (TCB) and the National Cancer Institute Enterprise Vocabulary Services (NCI-EVS), with participation and input from many other organizations.
An independent, non-profit organization established in 2005 with public and private philanthropic support from the Arizona community, Science Foundation Arizona, and the U.S. Food and Drug Administration (FDA), C-Path’s mission is to improve human health and well-being by developing new technologies and methods to accelerate the development and review of medical products. An international leader in forming collaborations, C-Path has established global, public-private partnerships that currently include 1,000+ scientists from government regulatory agencies, academia, patient advocacy organizations, and dozens of major pharmaceutical companies.


CDISC is a 501(c)(3) global non-profit charitable organization, with over 300 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop freely available, industry-wide clinical research data standards. The CDISC standards enable the sharing and aggregation of clinical data and streamline research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality research data. The CDISC standards and innovations have been shown to decrease the time and cost of medical research and improve data quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.