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WUSS 2009 CDISC for the Medical Device and Diagnostic Industry: An Update

WUSS 2009 CDISC for the Medical Device and Diagnostic Industry: An Update. Carey Smoak Team Leader CDISC Device SDTM Sub-team. Overview. Device Team Importance of Devices Differences between Devices and Pharma Team Mission Possible Unique Device Identifier Current Status SAS and CDISC.

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WUSS 2009 CDISC for the Medical Device and Diagnostic Industry: An Update

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  1. WUSS 2009CDISC for the Medical Device and Diagnostic Industry: An Update Carey Smoak Team Leader CDISC Device SDTM Sub-team

  2. Overview • Device Team • Importance of Devices • Differences between Devices and Pharma • Team Mission Possible • Unique Device Identifier • Current Status • SAS and CDISC

  3. Device Team • >50 Team Members • Industry Experts • CDISC Representatives • FDA Representatives

  4. Device Team • Industry Experts • U.S. and Europe • Areas of Expertise • Diagnostics • Imaging • Implantable Devices • Membership is open to anyone who wants to participate

  5. Device Team • CDISC • SDS (Submission Data Standards) • CDASH (Clinical Data Acquisition Standards Harmonization) • FDA • CDRH (Center for Devices and Radiological Health) • CBER (Center for Biologics Evaluation and Research)

  6. Importance of Devices • Devices in and of themselves are important: • heart stents may save peoples’ lives • blood screening assays help to keep the blood supply safe

  7. Importance of Devices • FDA • Last year (Jan-Nov, 2008), 697 Premarket Approvals (PMAs) were approved by CDRH • During the same time frame, 67 New Drug Applications (NDAs) were approved by CDER • This is not intended to imply that devices are more important than therapeutic products • Rather the point is simply that devices are important

  8. Importance of Devices • Devices are also important when used in conjunction with therapeutic products • Contrast agents in imaging devices may be used to monitor therapeutic agents • Drug eluting heart stents may be used to treat cardiovascular disease • Diagnostic assays may be used to determine if a therapeutic product will work in a patient • targeted therapies and companion diagnostics

  9. Differences between Devices and Pharma • Paper by Greg Campbell (CDRH) • A medical device is anything that is not either a drug or a biologic product • Mechanism of action • Medical devices are usually physical • Pharmaceutical products are usually chemical or biological.

  10. Differences between Devices and Pharma • Type of Product • Medical devices can be therapeutic, diagnostic or something else • Pharmaceutical products are usually therapeutic • Research • Medical devices are invented • Drugs (new chemical entities) are generally discovered

  11. Differences between Devices and Pharma • Development • Medical devices can be altered during clinical development • Once on the market a newer, improved version may be in development • Consequently, the life-cycle of a medical device may only be as short as a couple of years • In contrast, drugs are usually on the market for many years

  12. Differences between Devices and Pharma • Approval • Medical devices are approved through the Premarket Approval (PMA) application process • A single confirmatory study is often sufficient for approval • In contrast, drugs are approved through the New Drug Application (NDA) process • Drug development is characterized by Phases I through IV clinical trials.

  13. Differences between Devices and Pharma • Companies • There are more than 25,000 medical device companies registered with the FDA • Medical device companies are usually small (the median size is less than 50 employees) • In contrast, there are relatively few pharmaceutical companies • Pharmaceutical companies tend to be large

  14. Differences between Devices and Pharma • Products • There are tens of thousands of medical devices • The number of drug numbers in the thousands

  15. Differences between Devices and Pharma • In device studies, data is collected about: • Instruments • Assays • Specimens

  16. Differences between Devices and Pharma • This data does not currently fit into any CDISC domain • “Houston, we have a problem.”

  17. Team Mission Possible • Determine how device submission requirements fit within the context of SDTM • Identify gaps and ways to address them • Develop device domains as needed

  18. Team Mission Possible • February, 2009 INTRAchange • Device Team met with CDASH team and representatives from AdvaMed • Forged a strategy to: • Review the 16 CDASH domains • Create new device domains as needed

  19. Team Mission Possible • Review of 16 CDASH domains • CRF analysis sub-team • Collected more than 170 CRF from 40+ device companies

  20. Team Mission Possible • Create new device domains: • Device properties • Device disposition • Device accountability • Device malfunctions

  21. Team Mission Possible • Device Properties (DP) • Properties and/or characteristics about a device • Findings observation class domain

  22. Team Mission Possible

  23. Team Mission Possible • Device Malfunctions • May or may not be related to an Adverse Event • MedDRA • Unique Device Identifier

  24. Unique Device Identifier • On September 27, 2007 the FDA Amendments Act of 2007 was signed into law • This act includes language related to the establishment of a Unique Device Identification System

  25. Unique Device Identifier • This new system when implemented will require: • the label of a device to bear a unique identifier • the unique identifier to be able to identify the device through distribution and use • the unique identifier to include the lot or serial number if specified by FDA

  26. Unique Device Identifier • This unique device identifier is currently a work in progress by the FDA • For more information, please go to www.fda.gov/cdrh/ocd/udi

  27. New Domain Procedure An Initial Consensus Version (ICV) of the new SDTM and CDASH domains are achieved & other specific fields/terminology for the 16 CDASH Domains. Submit to CDISC Technical Leadership Committee and follow the Consensus Process. 27

  28. CDASH Component 16 Safety data domains developed Consolidated document posted for public review in May 2008 Received over 1800 comments from 46 companies, institutions and agencies. All 3 ICH regions were represented in the public comment process US Europe Japan CDASH V1.0 published 2008 Streamlines data collection at investigative sites - addresses Critical Path Opportunity #45 Continuation of ACRO’s Initiative Started October 2006 Supported by a collaborative group of 17 organizations Core team of 16 members manages.. 11 working groups Comprised of between 8-40 volunteers ~190 working group volunteers CDASH Project Snapshot

  29. CDASH Domains Common Identifier Variables Common Timing Variables Adverse Events (AE) Concomitant Medications (CM) Comments (CO) Drug Accountability (DA) Demographics (DM) Disposition (DS) Protocol Deviations (DV) ECG (EG) Exposure (EX) Inclusion Exclusion (IE) LAB Test Results (LB) Medical History (MH) Physical Exam (PE) Vital Signs (VS) Subject Characteristics (SC) Substance Use (SU) (N=16)

  30. CDASH Development Steps • Review CDASH v 1.0 all domains • Co- develop of SDTM domains • First time that this has been done • Device properties • Device disposition • Device accountability • Device malfunctions • Focused on CRF Content, not CRF Layout

  31. CDASH Development Steps • Collected CRF samples – frequency analysis • Evaluated commonalities/differences between CRF samples • Documented data points included/excluded with justifications

  32. CDASH Development Steps • Agree on basic device CRF collection fields  • Assign Core Designation (Highly recommended, etc.) • Map to draft SDTM domains

  33. CDASH Development Steps • Define required terminology – forward to Terminology team. • Develop CRF question definitions and completion instructions for clinical sites and sponsors • Incorporate new device domains into CDASH V 1.1

  34. CDASH Program Plan 2009-2010 ICVs Q409 CDASH-ODM CDASH V 1.1 CDASHUG 1.0 Released Q2 10 CDASH-ODM CDASH V 1.1 CDASHUG 1.0 Q4 09 Q2 10 CDISC Consensus Process

  35. SAS and CDISC • Clinical Standards Toolkit which will: • Validate the CDISC SDTM standard (both WebSDM and Janus rules) • Produce the CRT-DDS (define.xml) documentation files • http://www.sas.com/news/preleases/062308/SASforClinicalDI.html • Available with BASE/SAS

  36. SAS and CDISC • The Clinical Standards Toolkit is a set of macros which can be updated as standards change. • This last point is of benefit to devices. • When a new SDTM standard becomes available for devices then the Clinical Standards Toolkit should work for devices.

  37. SUMMARY • Devices are important! • Work is currently being done: • Review the 16 CDASH domains • Develop new domains • New team members are welcome!

  38. Contacts • Carey Smoak • Team Leader • Roche Molecular Systems, Inc. • E-mail: carey.smoak@roche.com

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