Transcript CDI_Smoak - Meta

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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Device Team
• >50 Team Members
– Industry Experts
– CDISC Representatives
– FDA Representatives
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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
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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
ABCDEF
Number
DP
DPSNUM
123456
Serial
Number
DP
DPSVER Software
1.2.3
Version
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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.
Initial
Consensus
Version (ICV)
TLC Review
Harmonized
Version (HV)
External
Focused
Review
Reviewed
Version (RV)
Public
Review
Released
(Production)
Version 1.0
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CDASH Component
CDASH Project Snapshot
• 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
• 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
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CDASH Domains
(N=16)
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Common Identifier Variables
Common Timing Variables
Adverse Events (AE)
Concomitant Medications
(CM)
Comments (CO)
Drug Accountability (DA)
Demographics (DM)
Disposition (DS)
Protocol Deviations (DV)
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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)
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CDASH Development Steps
• Review CDASH v 1.0 all domains
• Co- develop of SDTM domains
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First time that this has been done
Device properties
Device disposition
Device accountability
Device malfunctions
• Focused on CRF Content, not CRF Layout
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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
CDASHODM
CDASH
DEVICE
Set-1
ODM &
CRFs
Set-2
ODM &
CRFs
Set-3
ODM &
CRFs
Properties
Accountability
Malfunction
CDASH
V 1.1
Correction
/Additions
CDASH
CDASH
ODM
CRFs
User Guide
V 1.0
Q4
09
Device
domains
ICVs Q409
CDASH-ODM
CDASH V 1.1
CDASHUG
1.0
Released
Q2 10
CDASHODM
CDASH-ODM
CDASH V 1.1
CDASHUG 1.0
Q2
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CDISC CONSENSUS PROCESS
Initial
Consensus
Version (ICV)
TLC Review
Harmonized
Version (HV)
External
Focused
Review
Reviewed
Version (RV)
Public
Review
Released
(Production)
Version 1.0
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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/S
ASforClinicalDI.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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Contacts
• Carey Smoak
– Team Leader
– Roche Molecular Systems, Inc.
– E-mail: [email protected]
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