Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible)...
Transcript of Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible)...
![Page 1: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/1.jpg)
Don’t Dream the Impossible Dream
Presented by Steve Kirby (Reata Pharmaceuticals) and Mario Widel (Covance)
10.10.2018
![Page 2: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/2.jpg)
A Practical Approach to Automating End to End Standards
![Page 3: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/3.jpg)
Agenda
1. What it would take to fully live that (impossible) dream1. Collection and tabulation level
2. Analysis and submission level
3. Process maintenance level
2. A possible dream 1. Scope (start small)
2. Start with a subset of standard TFL shells and work back
3. Pilot process
4. Roll it out
3. Examples
![Page 4: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/4.jpg)
What would it takes to live that dream
![Page 5: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/5.jpg)
What it takes to live that dream – Collection and Tabulation
• Protocol templates are CDISC-friendly and consistently applied
• Source data collection standards leverage CDASH and are otherwise SDTM friendly
• Source data extracts are consistently formatted
• Source to SDTM mapping is fully defined and supported by robust code
Does this describe the current state at your company?
10/23/2018Footer Text 5
![Page 6: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/6.jpg)
What it takes to live that dream – analysis and submission
• SAP templates and standard analyses are fully defined and consistently
• ADaM specifications are fully defined based on standard SAP template and associated shells
• ADaM programming is fully defined and supported by robust code
• Data documentation (for SDTM and ADaM) is fully supported by standard mapping and is automatically generated
Does this describe the current state at your company?
10/23/2018Footer Text 6
![Page 7: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/7.jpg)
What it takes to live that dream – process maintenance
• Any special needs are accounted for by a robust waiver/exception process
• Everyone always follows all company implementation standards and associated processes
• Everything works exactly as expected
Does this describe the current state at any company?.
10/23/2018Footer Text 7
![Page 8: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/8.jpg)
A possible dream
![Page 9: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/9.jpg)
The Impossible Dream (a realistic look)
• Ain’t gonna happen*
• So let’s consider what part of that dream we can live
* Why not? What is so hard?.
10/23/2018Footer Text 9
![Page 10: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/10.jpg)
E2E standards on a budget
• We can’t live the whole dream
• Let’s focus on living part of the dream• Define some key elements from E2E
• And then automate and reuse
• After initial success:• If all is working well, expand from there.
• If not, refine the key elements (next slide, process flow)
10/23/2018Footer Text 10
![Page 11: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/11.jpg)
Define the initial scope of the E2E standards effort
• A good starting point: determine what analysis needs are the same across studies within a compound.
• Typically basic safety analyses work well for this stage.
10/23/2018Footer Text 11
![Page 12: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/12.jpg)
Start at the end and work back
• Define associated table shells,
• Work back from there to:• Associated SAP template sections,
• ADaM,
• SDTM,
• associated source data and
• related sections in the protocol.
• .
10/23/2018Footer Text 12
![Page 13: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/13.jpg)
E2E Process flow diagram
Standard
SAP Text
Standard
ADaM
Code
Standard
Table
Code
Test and
Approve
Define.xml
Standard
ADaM
DefinitionsSubset of
Std. Table
Shells
ADaM
AnnotatedSupports
Define/ARM
Based
on ARMBased on
Definitions
Accurate
and
Conformant
![Page 14: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/14.jpg)
Beware mission creep
• Small additions can sidetrack an otherwise well-formed plan
• Start small
• Stay small.
10/23/2018Footer Text 14
![Page 15: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/15.jpg)
Pilot process for proof of concept
• Build a sand-box area to pilot.
• One simple method is to leverage content from an appropriate completed study in a work directory.
10/23/2018Footer Text 15
![Page 16: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/16.jpg)
Appropriately time initial roll-out of process
• Best to schedule initial implementation with the first study in a sequence or similar to minimize disruption. .
10/23/2018Footer Text 16
![Page 17: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/17.jpg)
Examples
![Page 18: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/18.jpg)
Example implementation – Table Shell
10/23/2018Footer Text 18
![Page 19: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/19.jpg)
Example implementation – SAP
.
10/23/2018Footer Text 19
The following demographics and baseline characteristics will be summarized descriptively for the <insert populations as applicable>:
• Age in years*
• Gender
• Ethnicity
• Race
• Height in centimeters
• Weight in kilograms
• Body mass index*
• Alcohol history (never consumed, previously consumed, currently consumes) +
• Tobacco history (never used, previously used, currently uses) +
• <insert groupings (e.g. Age Groupings, Race Groupings) and additional parameters as needed
*See General Guidance for Statistical Programming document for default computational methods; methods that differ from or are not included in that document are specified.
+ Included if relevant
![Page 20: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/20.jpg)
Example implementation – ADaM
10/23/2018Footer Text 20
![Page 21: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/21.jpg)
Example implementation – SDTM
10/23/2018Footer Text 21
![Page 22: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/22.jpg)
Example implementation – Source Data
10/23/2018Footer Text 22
![Page 23: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/23.jpg)
Example implementation – Protocol
Demographics, Baseline Characteristics
The following demographics and baseline characteristics will be summarized descriptively for both the safety and ITT populations: age in years, gender, race, height, weight, body mass index.
10/23/2018Footer Text 23
![Page 24: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/24.jpg)
Example implementation – next steps
• Solicit feedback
10/23/2018Footer Text 24
![Page 25: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/25.jpg)
Questions?
10/23/2018Footer Text 25
![Page 26: Don’t Dream the Impossible Dream - CDISC · 1. What it would take to fully live that (impossible) dream 1. Collection and tabulation level 2. Analysis and submission level 3. Process](https://reader033.fdocuments.us/reader033/viewer/2022042106/5e85406c534daf7c175835f7/html5/thumbnails/26.jpg)
Thank You!