Dawn over the Baltimore harbor was spectacular from the Renaissance Harborside. We are most grateful that our three keynote speakers were willing to drive into the city while the sun was yet rising to deliver a superb opening session to the CDISC Interchange.
Douglas Fridsma, MD, PhD, Acting Director of the Office of Interoperability and Standards, Office of the National Coordinator (ONC) for Health Information Technology, spoke on the topic of “Enabling Meaningful Use: Developing Standards, Policies and Technologies for Secure Health Information Exchange”. He commented that, “Standards are standards because people USE them, not because they are told they have to use them. They should make processes easier and better.” The ONC wishes to provide tools, coordination and harmonization; they want to be seen as the enabler, not the barrier to standardization. He spoke of the need to integrate multiple SDOs in the process through engagement.
Theresa Mullin, PhD, Director, Office of Planning and Informatics, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration spoke on the topic of, “The FDA CDER Data Standards Plan”. She stated that the FDA must move forward towards electronic and standard data. The eCTD has been required by the EU and may be helpful to FDA since it allows them to be able to find things in a submission. However, she clarified that, “electronic but not fully standardized doesn’t get us where we need to go. We don’t want our reviewers to be in the business of cleaning the data, rather they should be reviewing the data.” They are currently working through policy changes and they need the infrastructure to be able to receive standard data. The plan is a comprehensive approach. “We have no intention of developing our own standards; we intend to work collaboratively with all of the stakeholders and relevant SDOs.” They are requesting CDISC standards for the forseeable future while concurrently exploring whether the standard serves their needs well enough. They are exploring various opportunities. She closed by saying that, “The doors are open for communication”.
Raymond Woosley, MD, PhD, CEO, Critical Path Institute, spoke about the Critical Path Institute, which was set up as a Public Private Partnership with the FDA and the State of Arizona. They are building scientific consensus on methods in drug development and work with both the Agency and Industry. Patients are calling for urgency in terms of wanting new therapies, hence C-Path has set up an unprecedented collaboration through the Coalition Against Major Diseases, involving biopharmaceutical companies, NIH, EMA, FDA, CDISC and others. Dr. Woosley commented that, “this is a case study on the ROI of using standards”. They have now developed a database, which includes data on over 4,000 patients with Alzheimer’s Disease and was made possible through the use of the CDISC standards such that the disparate legacy data could be aggregated and compared. In addition, the development of a new CDISC set of standards for Alzheimer’s efficacy data will now enable new studies to start up more quickly and will also streamlining the population of the database in the future with new study data. The larger database will improve the chance of finding an effect vs. a smaller sample size. Once C-Path and the study sponsors had the appropriate legal agreements to share information around Alzheimer’s studies, Dr. Woosley commented that the scientists have been having a ‘feeding frenzy’ with the data. The database is now available on the Internet (with de-identified patient data) to allow scientists to look for better and/or new therapies.
Our thanks again go to our wonderful keynote speakers, who opened the conference in such a powerful and thought provoking way. If you have any comments of suggestions for future keynote speakers, we would love to hear from you, leave a comment, or contact AJ de Montjoie, CDISC Director of Media & Communications.
Dr. Rebecca Kush
CDISC CEO & President