The PHUSE US Spring 2021 SDE was an interesting cross-section of perspectives on automation of Analysis and Reporting. My takeaway messages were:
- End-to-end machine readable standards are still a work-in-progress, and there is not a clear path to standardisation around e-Protocol and e-SAP
- CDISC aim to make it simpler to implement software that automates standards (rather than publishing standards as ‘600-page pdf documents’); this is based on the proprietary CDISC Library
- Key implementation challenges include: Managing change, Budgets (it takes longer than you think) and Silo business processes
- PHUSE have a mature set of safety reporting deliverables, including SAP definitions, statistical methods and visualizations. This can provide a solid basis for automation projects.
DISCLAIMER: I missed one session by Farha Feroze (Symbiance) on Automated TFL Moch Shell Generation using AI Techniques (ML/NL), so is not included in this report!
The day was (excellently!) chaired by Bhavin Busa, and Gurubaran Veeravel, who kicked-off with reference to the CDISC 360 ‘Future State – Analysis and Reporting’, noting that “we are not there yet!”
This is a future-state vision that is based on automating the current reporting pipeline. Currently ADaM and TFL programs are written manually.
Anthony Chow presented an overview of the CDISC Library, and current/future projects related to Analysis & Reporting
CDISC aim to make it simpler to build software that automates standards-based processes.
- The CDISC Library provides an application programming interface (API) to ‘normative metadata’ on all CDISC standards
- CDISC is working with open source projects on tools to access CDISC Library
- CDISC have Analysis & Results projects ongoing and about to start recruiting members: MACE+ project, Safety User Guide, and Analysis Results (ARM) Standard development.
Path to Automation
Andre Couturier & Dante Di Tommaso (Sanofi) gave an insightful presentation on the challenges facing when implementing end-to-end automation (for a start.. don’t call it automation!)
- It is key to communicate a clear vision and ‘sell upwards’
- Key challenges include change management, Silo business processes, and budget (it takes longer than you think!)
- Decide whether existing processes are ‘Deterministic’ or ‘Intelligent’ – Deterministic processes are candidates for automation, and Intelligent processes can be ‘facilitated’
- Sanofi use the acronym MAP (Metadata Assisted Programming) to describe the change in approach
Mary Nilsson (Eli Lilly) provided a comprehensive overview of the work that PHUSE has done on Safety Reporting. A comprehensive set of deliverables are available phuse.global
- The two working groups are: Standard Analyses and Code Sharing (pre-2020) and also Safety Analytics (post-2020)
- In addition there are training videos covering pooling data, safety analytics and for integrated reporting
- The deliverables include SAP text, statistical methods, and visualisations
- This is a body of knowledge that can provide a solid set of ‘source documentation’ for automation projects
Traceability and dependency
Gurubaran Veeravel walked-through how Merck perform impact analysis when standards change – specifically to determine program dependencies and variables used.
R demo – TFL Generation
Jem Chang & Vikram Karasala (AstraZeneca) presented how R programs can create RTF outputs with the same layout as existing (SAS) outputs. Alternative/existing R packages are available, and the pros/cons of each were discussed.