don’t dream the impossible dream - cdisc · 1. what it would take to fully live that (impossible)...
Post on 24-Mar-2020
3 Views
Preview:
TRANSCRIPT
Don’t Dream the Impossible Dream
Presented by Steve Kirby (Reata Pharmaceuticals) and Mario Widel (Covance)
10.10.2018
A Practical Approach to Automating End to End Standards
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
What would it takes to live that dream
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
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
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
A possible dream
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
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
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
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
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
Beware mission creep
• Small additions can sidetrack an otherwise well-formed plan
• Start small
• Stay small.
10/23/2018Footer Text 14
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
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
Examples
Example implementation – Table Shell
10/23/2018Footer Text 18
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
Example implementation – ADaM
10/23/2018Footer Text 20
Example implementation – SDTM
10/23/2018Footer Text 21
Example implementation – Source Data
10/23/2018Footer Text 22
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
Example implementation – next steps
• Solicit feedback
10/23/2018Footer Text 24
Questions?
10/23/2018Footer Text 25
Thank You!
top related