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WUSS 2009
CDISC for the Medical Device and Diagnostic Industry: An Update
Carey SmoakTeam Leader
CDISC Device SDTM Sub-team
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Overview• Device Team
• Importance of Devices
• Differences between Devices and Pharma
• Team Mission Possible
• Unique Device Identifier
• Current Status
• SAS and CDISC
Device Team• Industry Experts
– U.S. and Europe– Areas of Expertise
• Diagnostics• Imaging• Implantable Devices
– Membership is open to anyone who wants to participate
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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)
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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
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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
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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
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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.
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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
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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
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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.
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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
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Differences between Devices and Pharma
– Products
• There are tens of thousands of medical devices
• The number of drug numbers in the thousands
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Differences between Devices and Pharma
• In device studies, data is collected about:
– Instruments
– Assays
– Specimens
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Differences between Devices and Pharma
• This data does not currently fit into any CDISC domain
– “Houston, we have a problem.”
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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
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
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Team Mission Possible• Review of 16 CDASH domains
– CRF analysis sub-team– Collected more than 170 CRF from 40+
device companies
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Team Mission Possible• Create new device domains:
– Device properties– Device disposition– Device accountability– Device malfunctions
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Team Mission Possible
• Device Properties (DP)– Properties and/or characteristics about a
device– Findings observation class domain
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Team Mission Possible
Domain DPTESTCD DPTEST DPORRES DP DPMODEL Model
Number ABCDEF
DP DPSNUM Serial Number
123456
DP DPSVER Software Version
1.2.3
Team Mission Possible• Device Malfunctions
– May or may not be related to an Adverse Event
• MedDRA• Unique Device Identifier
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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
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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
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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
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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.
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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
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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)
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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
CDASH Development Steps• Collected CRF samples – frequency
analysis
• Evaluated commonalities/differences between CRF samples
• Documented data points included/excluded with justifications
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CDASH Development Steps• Agree on basic device CRF collection
fields
• Assign Core Designation (Highly recommended, etc.)
• Map to draft SDTM domains
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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
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CDASH Program Plan 2009-2010
ICVs Q409CDASH-ODMCDASH V 1.1
CDASHUG 1.0
ICVs Q409CDASH-ODMCDASH V 1.1
CDASHUG 1.0
CDISC CONSENSUS PROCESSQ210
Q409
ReleasedQ2 10
CDASH-ODMCDASH V 1.1CDASHUG 1.0
ReleasedQ2 10
CDASH-ODMCDASH V 1.1CDASHUG 1.0
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
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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.
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SUMMARY• Devices are important!
• Work is currently being done:– Review the 16 CDASH domains– Develop new domains
• New team members are welcome!
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