CDISC, C-Path, FDA, TransCelerate and the Global CDISC Community Launch Initiative to Accelerate Therapies Through Standards
November 12, 2012
Austin, TX – 6 November 2012 – The CDISC International Interchange in Baltimore, Maryland, held 22-26 October 2012, was the formal launch of the Coalition for Accelerating Standards and Therapies (CFAST). It also marked the 10th anniversary of these CDISC Interchanges. In 2003 at the first North American CDISC Interchange, Dr. Mark McClellan, then FDA Commissioner, gave the keynote speech, stating “I think that CDISC will be a big part of moving FDA onto an electronic information architecture where we can realize all of these opportunities [benefits of technology]. I think this will have a profound and positive impact on our drug review process, allowing us to design trials that can be less expensive and still tell us more about the risks and benefits of a new medical product. And I think that the most significant and perhaps enduring legacy to your efforts could be the very immediate and significant impact it has on improving the lives of patients.”
Over the past 10 years, through the support of enlightened organizations and dedicated efforts of thousands of volunteers around the globe, CDISC has developed a suite of global data standards to streamline research from protocol (planning) through analysis and reporting, including an established link with healthcare. Enhancement of these foundational CDISC standards with those elements specific to therapeutic areas still need to take place to support fully standardized electronic regulatory submissions for FDA.
FDA representatives in Baltimore this year announced that recent statutes mean that FDA will be working with SDOs (i.e. CDISC) to develop the terminology and remaining standards to support specific therapeutic areas and that FDA will begin requiring standardized electronic submissions for evaluation of new therapies/products by 2017. In her keynote presentation at the CDISC Interchange, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at FDA, stated “Through CFAST, we seek to accelerate clinical research and medical product development by facilitating the creation and maintenance of data standards, tools and methods for conducting research in therapeutic areas important to public health.”
CFAST, announced 10 September 2012, is being realized through a partnership between CDISC and the Critical Path Institute (C-Path). The CFAST Charter states that any clinical data standards produced under this partnership will be created under the CDISC standards development process, and those standards will then be published openly on the CDISC website as global CDISC standards. One key objective is to ensure that the CDISC process is robust and consensus-based, yet as rapid as possible. The recently formed TransCelerate BioPharma, Inc. has joined the CFAST partnership to assist CDISC by providing greater access to resources from the pharmaceutical industry that will contribute to standards development projects. “Our goal at TransCelerate with the Therapeutic Area (TA) Data Standards Project is to contribute our efforts and investments to assist and partner with CDISC, C-Path and FDA to complete CFAST TA data standards projects more rapidly and to allow CDISC to roll out new TA data standards every few months as particular disease areas are completed,” said Dr. Garry Neil, CEO of TransCelerate.
At the CDISC Interchange, Ann Martin, Principal Scientific Manager, Knowledge Management for the European Innovative Medicines Initiative (IMI) discussed how CDISC is contributing to the IMI projects and how IMI is using CDISC standards, and Dr. Youji Nagai spoke about the use of the CDISC standards at the Translational Research Informatics Institute (TRI) of Japan. Through the essential contributions and participation of partners such as IMI, TRI, the National Cancer Institute, TransCelerate, C-Path, One Mind for Research, the Bill and Melinda Gates Foundation, TB Alliance, American College of Cardiology; Duke, Tufts and Rockefeller Universities; and many other partners, CDISC has developed and posted TA standards for Alzheimer’s Disease, Pain and Tuberculosis, with Cardiovascular Disease, Parkinson’s Disease, Polycystic Kidney Disease and Virology TA standards currently under review.
“Patients don’t know why standards are important, if they did they would be lobbying Congress to provide more funding for standards development” said Sue Dubman of Sanofi (also on the CDISC Board of Directors and a Parkinson’s patient). “Similar to the FDA reviewer working with a submission, as much as 50% of a researcher’s time in therapeutic product development can be spent on data management (entering and re-entering, copying, pasting, classifying, coding, editing, converting, verifying and reconciling data). Implementing CDISC standards end to end, across the clinical data lifecycle, starting with the CDISC Protocol Representation Model, could automate many time- consuming and labor intensive processes. Every minute that a researcher spends time on managing data instead of analyzing data is a minute lost to product development. From a patient’s point of view that is unacceptable. Time is every patient’s most precious commodity. Patients can’t wait 15-20 years for new treatments to come to market. While standards are not a panacea, they are a necessary component to streamline and shorten the development process. ”
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 consensus-based, industry-wide data standards enabling the harmonization of clinical data and streamlining 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 can decrease the time and cost of medical research and improve 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.
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