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2011 CDISC Interchange: Looking at the Big Picture

2011 CDISC Interchange: Looking at the Big Picture. General remarks. Fewer participants (because of high admission fee ?) More exhibitors with interesting tools Posters with CDISC updates and ‘not accepted’ presentations

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2011 CDISC Interchange: Looking at the Big Picture

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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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