June has been a month full of interesting meetings, events and
activities for CDISC. In particular, Bron Kisler and I attended a set
of meetings in the Washington, DC area 8-11 June while others within
CDISC met face-to-face in Philadelphia to advance the CDISC SHARE project. And the following week, of course, was the Annual DIA meeting in DC where we saw old friends, gave multiple presentations and CDISC held a Healthcare Link demo in the exhibit area. I wanted to share just a bit about what stands out from my perspective, primarily on our initial meetings, and would welcome others to do the same….especially about the DIA event.
Bron and I started with a great meeting on 8 June with folks at the National Quality Forum. Dr. Floyd Eisenberg worked with CDISC (Landen Bain) on several of the IHE Integration Profiles, such as the Retrieve Form Data (RFD), which was designed to enable the use of electronic health records for a number of important purposes, including clinical research (providing CDASH datasets), safety reporting, quality reporting and public health. The goal of our meeting this month was to discuss ways to harmonize quality measures and clinical research information at the element/value set (codelist) level. One opportunity may potentially be provided through CDISC SHARE (with the semantic infrastructure being developed through the NCI Enterprise Vocabulary Services).
That afternoon we met, along with Dr. Woosley and several folks from the Critical Path Institute at FDA (with Drs. Woodcock, Mullin, Cooper, McCune from CDER) to obtain input into our strategic plans for the future. Two significant documents were released just recently: the CDER Data Standards Plan V1.0 and an update to the PDUFA IV Information Technology (IT) Plan. The former is posted for comment through mid-September. Please see a related Blog with links to these documents and highlights I have found in reading them.
On 9 June, Bron and I met with Dr. Jack Jones (CIO, NIH) and some of his staff members and with Dr. Steven Hirschfeld (NICHD), who is leading the US National Children’s Study to discuss ways to work with NIH in the development of standards for certain therapeutic areas and for pediatric studies. We will be providing a training course at NICHD and working with Dr. Hirschfeld towards eventual CDISC standards for pediatrics.
Finally, Bron attended a 2-day meeting (9-10 June) on advancing cures for Tuberculosis (which he has documented in a separate blog). And, on 11 June, Chris Tolk, Bron and I attended a press conference for the Alzheimer’s Initiative of the Coalition Against Major Diseases (CAMD) organized through the Critical Path Institute and Brookings Institute on Healthcare Reform. This is a very exciting global project through which a database has been created with data from over 4,000 Alzheimer’s patients; the goal is that better therapies can be developed on the basis of improved understanding of the diseases. This project provides a unique new model for science and the development of new therapies through collaboration (including Patient Advocacy Organizations, Biopharmaceutical Companies, FDA, NIH, the European Medicines Agency and other organizations including Brookings and CDISC ).
The hope for all involved in CAMD is that clinical research studies can be more efficient and effective to hasten development and approval of these therapies. The key is the size of the population being studied; the aggregated database was made possible through the use of CDISC standards. CDISC has also been supporting the development of standards to augment SDTM, Terminology and CDASH with the data elements specifically needed to measure the efficacy of Alzheimer’s treatments. And the pharmaceutical members of CAMD have agreed to use these standards in their future submissions for drug approvals, which should improve the review process. The press release states: “This will add greater efficiencies to the FDA’s review process and make it possible for new products to reach the market more quickly and with greater assurances of safety and effectiveness. Dr. Sharfstein (FDA Principal Deputy Commissioner) states: “The U.S. Food and Drug Administration has supported and actively participated in this innovative and unprecedented public-private partnership from its inception. The agency is strongly committed to CAMD and other regulatory science collaborations that can speed safe and effective treatments to the public.” Another disease being studied through this collaboration is Parkinson’s Disease. CDISC has enjoyed its collaboration with the Critical Path Institute and others on these projects and is pleased to be able to contribute to such important progress through the CDISC standards.
Finally, we can see that people all across the spectrum—from patients and VPs to project managers, data managers and statisticians---are realizing the value of CDISC standards and the Healthcare Link initiative. This is important in ensuring the stability and longevity of the CDISC organization and its role in developing and maintaining clinical research standards that link nicely with standards in the healthcare arena to ultimately improve the lives of patients….which means all of us.
