1. SDTMs in Medical Devices A First Attempt
Phil Hall
Distinguished Statistical Programmer
Edwards Lifesciences
Irvine, CA

2. Introduction CDISC now required for pharmaceutical trials
No date set for medical device trials
Medical device companies getting prepared

3. Agenda What are Medical Devices?
Similarities with Pharmaceutical Studies
Use of Device Specific Domains
Differences of Medical Device Trials
Procedure Data
CEC Adjudicated Data
Day 0
Future Work
Questions

4. What is a Medical Device?
A man-made device which is placed on, in or near the body to cure, treat, diagnose or prevent a disease.
Phil Hall © 2017

5. Class I / II Medical Devices

6. Class III Medical DevicesON IN
NEAR

7. SAPIEN 3 Transcatheter Heart Valve
#WUSS16

8. Edwards Approach to SDTM Mapping
CDISC Study Data Tabulation Model Implementation Guide (SDTM IG): Human Clinical Trials Version 3.2
Study Data Tabulation Model Implementation Guide for Medical Devices (SDTMIG-MD): Version 1.0
Keep as simple as possible
Plan for the future
Used proposed domains for V3.3

9. Edwards Approach to SDTM Mapping
1) Low hanging fruit
AE, MH, LB, VS etc.
Using SUPPxx
2) Cross-form domains
DM, DS, SV
3) Others
SDTM Consistency Committee
Propose – Debate - Agree

10. 94 square pegs into 25 round holes
SDTM Mapping
CRFs
Informed Consent
Demographics
Medical History
SF-36
SDTM Domains DM MH QS
94 square pegs into 25 round holes
94 round pegs into 25 square holes.

11. Challenges SDTMs designed for drug trials not medical devices
Multiple correct answers

12. Domains Domain Type Domain Trial Design Domains TA, TD, TE, TI, TS, TV
Special-Purpose Domains
DM, SV
Interventions General Observation Class CM
Events General Observation Class
AE, CE, DS, DV, HO, MH
Findings
EG, IE, DD, LB, MO, QS, RS, VS, FT
Device Domains
DE, DI, DT, DX
Custom Domains
XC, XP, YP

13. Trial Design Domains TA (Trial Arms) TD (Trial Disease Assessments)
TE (Trial Elements)
TI (Trial Inclusion / Exclusion Criteria)
TS (Trial Summary Information)
TV (Trial Visits)

14. Common Domains AE (Adverse Events)
CM (Concomitant and Prior Medications)
DD (Death Details)
DM (Demographics)
DS (Disposition)
DV (Protocol Deviations)
EG (ECG Results)
FT (Functional Test – Proposed for V3.3)*
IE (Inclusion / Exclusion Criteria Not Met)
HO (Healthcare Encounters)
LB (Laboratory Test Results)
MH (Medical History)
MO (Morphology)
QS (Questionnaires)
RS (Disease Response – currently only for oncology studies in V3.2 but being expanded for all indications in V3.3)**
SV (Subject Visits)
VS (Vital Signs)
* What to Expect in SDTMIG v3.3, Fred Wood, PharmaSUG2015 **

15. Domains Domain Type Domain Trial Design Domains TA, TD, TE, TI, TS, TV
Special-Purpose Domains
DM, SV
Interventions General Observation Class CM
Events General Observation Class
AE, CE, DS, DV, HO, MH
Findings
EG, IE, DD, LB, MO, QS, RS, VS, FT
Device Domains
DE, DI, DT, DX
Custom Domains
XC, XP, YP
#WUSS17

16. Device Specific Domains
Study Data Tabulation Model Implementation Guide for Medical Devices (SDTMIG-MD): Version 1.0
Seven Domains
Study Device Identifiers (DI)*
Device In-Use (DU)
Device Exposure (DX)*
Device Events (DE)*
Device Tracking and Disposition (DT)*
Device-Subject Relationships (DR)
Device Properties (DO)

17. Study Device Identifiers (DI)*
The primary purpose of this domain is to provide a consistent sponsor-defined variable (SPDEVID) for linking data across Device domains. Device Identifiers exist independently from subjects and therefore the Study DI domain does not contain USUBJID.

18. Device In-Use (DU)
Device In-Use is a Findings domain that contains the values of measurements and settings that are intentionally set on a device when it is used, and may vary from subject to subject or other target. These are characteristics that exist for the device, and have a specific setting for a use instance.

19. Device Exposure (DX)*
Device Exposure is an Interventions domain that records the details of a subject’s exposure to a medical device under study.

20. Device Events (DE)*
DE is an Events domain that contains information about various kinds of device-related events, such as device malfunctions.

21. Device Tracking and Disposition (DT)*
The Device Tracking and Disposition domain is an Events domain that represents a record of tracking events for a given device. This could include initial shipment, deployment, return, destruction, etc.

22. Device-Subject Relationships (DR)
The Device-Subject Relationships domain is a special-purpose domain that links each subject to devices to which they may have been exposed.

23. Device Properties (DO)
The Device Properties Findings domain is used to report characteristics of the device that are important to include in the submission, do not vary over the course of the study but are not used to identify the device. Examples include expiration date or shelf life.

24. Procedure Data
Options
PR Domain
Device-specific Domain
Custom Domain

25. PR Domain PR – Assumptions for the Procedures Domain Model
The Procedures domain model reflects collected details describing a subject’s therapeutic and diagnostic procedures. Some example procedures by type include the following:
a. disease screening
b. endoscopic examinations
c. diagnostic tests
d. therapeutic procedures
e. surgical procedures (e.g., curative surgery, diagnostic surgery, palliative surgery, therapeutic surgery, prophylactic surgery, resection, stenting, hysterectomy, tubal ligation, implantation)
CDISC Study Data Tabulation Model Implementation Guide (SDTM IG): Human Clinical Trials Version 3.2

26. Procedure Data Standardized Procedure Name
Start Date/Time of Procedure
End Date/Time of Procedure
Study Day of Start of Procedure
Study Day of End of Procedure
Subject treated according to assignment
Intended Approach
Actual Approach
Valve Size (mm)
Type of anesthesia used
Anesthesia Start Datetime
Anesthesia Stop Datetime
Specify Procedure aborted reason

27. X Procedure Data Options PR Domain Device-specific Domain
Custom Domain X

28. Adjudicated Data Clinical Endpoint Committee (CEC)
Independent panel of experts reviewing clinical data to give expert opinion on certain events of interest.
More common in medical devices but not unique
Examples
Disabling / Non-disabling Stroke
Cardiovascular / Non-cardiovascular Mortality
Re-hospitalization Due to Valve-related Symptoms

29. Adjudicated Data Options Add to AE Domain CE (Clinical Events) Domain
A dataset used to capture clinical events of interest that would not be classified as adverse events.
Custom Domain

30. X X Adjudicated Data Options Add to AE Domain
Not a 1-to-1 relationship
CE (Clinical Events) Domain
Custom Domain X X

31. Day 0 vs Day 1 Medical Devices Day of Implant Procedure = Day 0
Pharmaceutical
Day of First Dose = Day 1

32. Domains Domain Type Domain Trial Design Domains TA, TD, TE, TI, TS, TV
Special-Purpose Domains
DM, SV
Interventions General Observation Class CM
Events General Observation Class
AE, CE, DS, DV, HO, MH
Findings
EG, IE, DD, LB, MO, QS, RS, VS, FT
Device Domains
DE, DI, DT, DX
Custom Domain
XC, XP, YP

33. Custom Domains The ‘Other, specify’ of domains Case Review (XC)
Concomitant Procedures (XP)
Procedure (YP)

34. Deviations From Standards
No 200 character limit
Limited recoding
Day 0
No EX domain
Spend the time updating CRFs

35. Summary of Advice Use basic pharma domains where obvious to use
AE, MH, VS, LB etc.
Create trial design domains
Use device-specific domains where appropriate
Use CE domain for adjudicated data
Use custom domains for anything else
Can’t be CDISC compliant without proper CRFs so keep first attempt simple

36. Future Work CRFs – CDASH New / Updated Domains
DP / PR
Pinnacle 21 / Open CDISC accommodations
Second Attempt

37. Questions? ?

38. Contact Details
Phil Hall Edwards Lifesciences One Edwards Way Irvine CA
#WUSS17
38 #WUSS14