Six New SDTM Domains for Medical Devices

Six New SDTM Domains
for Medical Devices
Carey G. Smoak
Roche Molecular Systems, Inc.
Pleasanton, CA

OVERVIEW
• Introduction
• Setting the Stage
• 6 New SDTM Domains for Devices
• Conclusion

Setting the Stage
• Blood screening devices keep blood supply
safe
• Heart stents save peoples’ lives

Setting the Stage
• Devices are used in combination with
pharmaceutical products:
• Drug-eluting heart stents
• Companion diagnostics and targeted therapies

Setting the Stage
• Classification of Devices
• intended use of the device and also upon
indications for use
• Class I – minimal risk to the user
• enemas, crutches, elastic bandages, bedpans

Setting the Stage
• Class II – moderate risk to the user
• condoms, intravenous administration sets, sutures,
inflatable blood pressure cuffs
• Class III – severe risk to the user
• implantable pacemakers, blood vessel stents,
breast implants

Setting the Stage
• Examples of recent devices cleared or
approved by CDRH:
• Bone fixation devices that include plates,
screws and washers to treat fractures
• BRAF V600E Mutation Test which is intended
to be used in selecting melanoma patients
whose tumors carry the BRAF V600E mutation
for treatment with vemurafenib (zelboraf).

Setting the Stage
• Number of Pre-Market Approvals (PMAs)
by CDRH
• Year 2000: 488
• Year 2009: 740
• Increase: 52%

Setting the Stage
• Most submissions today are paper-based
• SAS transport files can be submitted, but
CDRH may also request data in Excel
spreadsheets
• pdf files (examples: data listings, summary
tables) can also be sent electronically

Setting the Stage
• This effort seeks to develop collection &
submission standards to support electronic
submission of:
• PMAs
• 510k
• Biologic License Applications (BLAs)

Setting the Stage
• The Device sub-team is a cooperative
effort between:
• CDRH and CBER at the FDA
• Industry experts
• Members of the CDISC CDASH/SDS teams

CDISC
• CRF Analysis of 138 CRFs from various
device companies
• Compared to CDASH domains
• Identified differences
• Recommended solutions

CDISC
• Examples of differences (CRF analysis):
• AE -> 1 AE associated with multiple devices
• Being worked on by SDS team (also applies to
multiple drugs)
• AE -> Relationship to multiple devices
• Being worked on by Terminology team

CDISC
• Examples of differences (CRF analysis):
• AE -> for lab operators (not subjects)
• Non-subject data domains under development
• DV -> Protocol deviations for devices
(instruments)
• Add device identifier to domain

CDISC
• Public Review of these 6 SDTM domains
• Device Information
• Device In-Use Properties
• Device Subject-Relationship
• Device Events
• Device Exposure
• Device Tracking and Disposition

Device Domains ER Diagram
Device Specifications
(Generic)
Device Deployment
With or Without
Subject Contact
(Specific Device)
Device In Use
Properties
DU
Device Contact with Subjects
(Specific Device)
Image
Generation*?
Image
Results
Subject-Device
Relationships DR
Demographics
Device
Information
DI
Device
Tracking &
Disposition DT
Device
Exposure DX
Subject
Exposure *
Device Events
DE
Adverse
Events *
Subject
Disposition
Domain Capturing Device-Related Data
Device Domains Specifically for Imaging
Clinical Domains
* Domain not developed yet or not yet customized for Device trials
Version September 2011

CDISC
• Two new variables will be needed:
• Generic device identifiers
• Unique device identifiers

CONCLUSION
• 6 New SDTM Device domains are almost
ready for public review!

CONTACT INFORMATION
Carey G. Smoak
Roche Molecular Systems, Inc.
carey.smoak@roche.com