What We Need to Know About CDISC


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Shannon Labout has more than 17 years of experience in healthcare technologies, project management and clinical research. She is the past Senior Director of Education at CDISC, and has developed and delivered training on CDISC standards for audiences in North America, Europe and Asia since 2007. She has been involved in CDASH since the beginning of the project in 2006, co-led the CDASH team for the past 3-1/2 years, and has been a contributing member of the SDS team since 2007. She has participated in CRF standardization for the past fourteen years, and been involved in data standards development, harmonization and implementation at several CROs and global pharmaceutical companies. She has managed clinical data management teams in both the U.S. and Europe, and is currently the Director Data Management at Statistics & Data Corporation based in Tempe, Arizona.
Source: http://www.arena-international.com/ecdm/shannon-labout/3038.speaker

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What We Need to Know About CDISC

  1. 1. What we need to know about CDISCShannon Labout, CCDMDirector, Data Management
  2. 2. WHAT WE NEED TO KNOW ABOUT CDISC What are the CDISC standards? What is the best timing to implement CDISC standards in a clinical program? What is the timeline for requiring CDISC Standards in FDA Submissions?
  3. 3. WHAT ARE THE CDISC STANDARDS CDISC organized as a non-profit standards developing organization (SDO) in 2000 CDISC works closely with other SDOs (e.g., HL7, ISO) and with the FDA CDISC develops standards for medical research (started with volunteers in 1990s) CDISC standards development is an open, consensus-based process, powered by volunteers www.CDISC.org
  4. 4. http://www.cdisc.org/foundation-standards
  5. 5. TIMING OF IMPLEMENTATION MATTERS!1. If you choose to convert your legacy data to SDTM at the end of the process Allows you to hold on to your old processes and standards But… Adds significant time, effort, and expense at the end of the process Legacy data conversion can introduce other significant problems
  6. 6. LEGACY DATA CONVERSION PROBLEMS No 1:1 relationship between CRF and SDTM domains/variables means you will have to spend a lot of time mapping data to the right domains/variables Collected values may not map to controlled terminologies that are required No standards definitions/assumptions make the data less “combinable” – may not be able to map with the same meaning
  7. 7. TIMING OF IMPLEMENTATION MATTERS!2. Streamline your processes by building (industry) standards into your process up-front:  Saves time, money, effort  Automatically generate deliverables throughout  Build a standard library of CRFs, database structures, SAS programming, etc.  Reduce (or eliminates) mapping and re-programming throughout the process  Makes data more combinable, re-usable  Allows data sharing with vendors and other research partners more easily  Supports FDA objectives  Standard format for data submissions and data repository  Builds in transparency and traceability
  8. 8. IMPLEMENT STANDARDS FROM THE START ODM – designed to hold CDISC content plus audit trail, based on XML PRM – structured protocol information makes it reusable downstream (registries, EDC, CSR, labeling), based on XML CDASH – standard metadata for CRFs is harmonized with other CDISC standards – makes it easier to get to SDTM and ADaM Controlled terminologies with standard definitions  Everyone collecting the same information the same way makes that data more usable and meaningful in a data repository
  10. 10. YES! CDISC STANDARDS WILL BE REQUIRED Supporting the Vision, Innovation and Opportunity of the Critical Path Initiative
  12. 12. Whichever way we choose to look at it…CDISC STANDARDS ARE NOLONGER OPTIONAL FOR FDASUBMISSIONS
  13. 13. 2004Critical Path Initiative
  14. 14. http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm
  15. 15. CRITICAL PATH INITIATIVE The Critical Path Initiative (CPI) is FDAs national strategy to drive innovation in the scientific processes through which medical products are developed, evaluated, and manufactured. FDA was hoping that industry would voluntarily adopt standards…
  16. 16. 2004 Critical 2006 Federal Path Register Initiative Notice
  17. 17. FEDERAL REGISTER NOTICE In 2006, FDA told us the requirement was coming all submissions to be electronic all submissions to follow standard formats (e.g., SDTM) They were still hoping we would voluntarily adopt standards…
  18. 18. 2004 2006 2008 2010 Critical Federal Federal Federal Path Register Register RegisterInitiative Notice Notice Notice
  19. 19. WHAT’S HAPPENED SINCE THEN? ARRA $$ invested in FDA’s standards implementation CDER Computational Science Center Cross-Center FDA Data Standards Council New Software and Tools New Review Environment Janus V1, V2, V3 CDISC training developed for FDA reviewers CDISC Standards are being built in at FDA
  21. 21. FDASIA Food and Drug Administration Safety and Innovation Act of 2012 Signed into law July 2012 Became effective October 2012 a few key points Reauthorizes PDUFA and MDUFA Creates User Fees for Biosimilars and Generics Section 1136 requires electronic submissions in a standard format to be referenced in binding Guidance
  22. 22. PDUFA V IT PLANObjective“FDA is committed to achieve the long-term goal of improving the exchange, review, and management of human drug and biologic applications throughout the product life cycle through strategic investments in automated, standards-based information technology (IT).”
  23. 23. BINDING GUIDANCEFDA will issue final guidance no later than 12 months from the close of the public comment period on the draft guidance. Such final guidance and any subsequent revisions to the final guidance shall be binding on sponsors, applicants, and manufacturers no earlier than twenty-four months after issuance of the final guidance.
  24. 24. DRAFT GUIDANCE ISSUED 2012  Harmonized cross-center  CDER – Drug applications  CBER – Biologics applications  CDRH – Device / Radiological applications  Specifies the requirement for electronic submission in a standard format  FDA publishes the standard formats they will accept on their data standards web page  References these CDISC standards  SDTM - tabulations of collected data  Controlled Terminology – allowed values  ADaM – analysis datasets (supports CSR)  SEND – pre-clinical data (based on SDTM)  Define.xml – standard metadata formathttp://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm
  26. 26. DEVELOPING TA STANDARDS FDA has published intent to help industry create therapeutic area (TA) specific standards by 2017 (PDUFA V commitment letter) High priority therapeutic areas published on FDA website(http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Form sSubmissionRequirements/ElectronicSubmissions/ucm287408.h tm#_ftnref10) Working with CDISC and others to develop TA Standards development open to all who can participate (http://www.cdisc.org/therapeutic)
  27. 27. FDA Timeline This assumes standardization projects for therapeutic areas would be scoped narrowly enoughto be accomplishable within a 12-month period, and that subsequent projects in those areaswould build on the results.
  28. 28. CDISC Timeline
  29. 29. HOW WE CAN STAY UP TO DATE Monthly CDISC webinars Updates on what’s being released for public review – new domains, new terminology, etc Free to attend live webinar Archives are available on demand to CDISC members CDISC Newsletter (monthly, free) CDISC website (www.cdisc.org) CDISC Education & Events Private and public courses Conferences (Interchange) in US, EU and AP
  30. 30. RESOURCES www.cdisc.org/foundational-standards - Starting point for all the standards http://www.cdisc.org/content6283 - Technical development plan (Gantt chart) http://www.fda.gov/ForIndustry/DataStandards/ StudyDataStandards/default.htm  Email accounts for questions (cber.cdisc@fda.hhs.gov, cder-edata@fda.hhs.gov, cdrh.cdisc@fda.hhs.gov) http://www.opencdisc.org/  Validation of your submission  Help with Define.xml
  31. 31. TAKE AWAY MESSAGES It’s time to implement CDISC standards - no longer optional for FDA submissions Right now – FDA wants SDTM/ADaM In the near future – FDA will require SDTM/ADaM Update / improve your processes to take full advantage of these industry standards Get involved with standards development Contribute your TA-specific knowledge Help develop the standards we all will have to use
  32. 32. THANK YOU! Shannon Labout, CCDMDirector, Data Management slabout@sdcclinical.com