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Insights from the 2011 CDISC Interchange: Trends and Future Directions in Clinical Data Standards

The 2011 CDISC Interchange presented several key insights into clinical research data standards. While attendance was lower due to high admission fees, exhibitor participation was vibrant with innovative tools. Sessions included a mix of high-level presentations and panel discussions on topics such as global clinical networks and health systems. Notably, the FDA's commitment to CDISC was evident, with plans for fully standardized submissions by 2017 and guidance on using CDISC standards expected. Challenges remain, with only 25% of NDAs including CDISC data.

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Insights from the 2011 CDISC Interchange: Trends and Future Directions in Clinical Data Standards

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  1. 2011 CDISC Interchange: Looking at the Big Picture

  2. General remarks • Fewer participants (because of high admission fee ?) • More exhibitors with interesting tools • Posters with CDISC updates and ‘not accepted’ presentations • Discussion groups were organized as Round Table Discussion during lunch – with mixed success • Several sessions organized as panel discussions

  3. Remarks about sessions • Many high level and big picture presentations • Clinical research and healthcare • Learning Health System • How to build a Global Network for Clinical Research • and more … • Several define.xml presentation (M. Molter, P. Verplanke • FDA presentation about .xpt file size (D. Chhatre, CDER/OBI) • CDISC for population PK

  4. Strong FDA Participation • Clearly, FDA is completely committed to CDISC • Still driving the legacy data conversion project, plan to publish some of the experience with the conversion • FDA expects “fully standardized submissions” by 2017 • Committed to OpenCDISC for validation • When using standards in submission, discuss it as early as possible • CDER • Quality of clinical data is more critical than adherence to standard • Developing guidance on how to use CDISC standards – ETA late 2011 or early 2012 • (Only) 25% of active NDAs contain CDISC data (in 2010), so “non-standard” data is still a big challenge • CBER • Plan to provide more guidance - for example, a data standards plan, SOP for submissions, and a common issues document • Auditing SUPPQUAL and custom domains • Was looking for volunteer for SEND submissions

  5. Current Focus and Future directions • Currently, Metadata is one of the hot topics: what is needed, how to collect, how to store, how to use, … • Aggregation of data for sharing and for mining (for example, CPATH for Alzheimer data) • Standards for therapeutic areas , 9 areas are under development • Extension of standards to devices, 6 new SDTM device domains in progress

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