Last week was the CDISC EU Interchange conference in Vienna, a key event on the calendar for Cytel’s statistical programming subject matter experts . Angelo Tinazzi, Director, Statistical Programming, Clinical Data Standards and Clinical Data Submission at Cytel co-chaired the sessions on Foundational Standards and Standards Governance alongside Astrazeneca’s Daniel Graham, and delivered a presentation on Traceability within the Foundational standards track.
In this blog, Angelo highlights some of the hot topics which emerged from the presentations he attended during the meeting.
The second plenary session included updates from the leading regulatory agencies. Dr. Fergus Sweeney and Enrica Alteri presented from the EMA, Dr Yuki Ando from the PMDA and Dr. Eileen Navarro, Dr. Lilliam Rosario and Dr. Steve Wilson, from the FDA. Here are some key insights which emerged from their talks:
- There were clear distinctions in the approaches and priorities of the agencies. The FDA and PMDA are primarily focused on regulating data submission, thus accepting electronic data submission through CDISC standards. The EMA is adopting a top-down approach and as such, is more focused on topics such as data transparency. Nevertheless, topics such as data integration and interoperability form part of the EMA’s plans.
- As has been well documented, the FDA will no longer accept non-CDISC data submission after December 2016 (for trials started after this date). Currently 75% of submissions to the FDA are SDTM based. Within their presentation the FDA shared some key critical items / issues in the SDTM datasets they have received so far. These include (but are not limited to ): lack of, or incomplete documentation (i.e. define.xml and Reviewer's Guide); duplicated information; missing key information (such as seriousness criteria in the AE pane). They stressed the importance of having these issues fixed prior to submission. Not doing so will result in questions from the reviewer and delays in the approval process. The PMDA is currently working in a pilot phase, but are already accepting eSubmissions - after Oct 2016 CDISC submissions will be mandatory.
The issue of standards governance is a hot topic in the industry. With the evolution of the standards available and their complexity, many large and medium size pharma companies have created dedicated teams for standards governance. In the examples provided during the conference, such teams might have 4 to 6 people of which 75% are fully dedicated ( within a mid- size to large pharma company). This insight is one of the outcomes of a survey of a work stream of the Transcelerate initiative. This particular Transcelerate workstream is aiming to develop working practice to help pharma industries establishing Standards Governance Teams. Leading pharmaceutical companies Janssen and Roche shared their own approaches to standards governance with the delegates.
Therapy specific implementation
There was a heavy focus on the implementation of CDISC within different TAs, such as diabetes ,with Anja Lundgreen and Mikkel Traun of Novo Nordisk presenting on challenges of adapting the user guide. There was also focus on TAs that could be the object of new TA guidance such as vaccines and haemophilia. A presentation from Philip Morris discussed how they apply CDISC standards in support of regulatory submissions for modified risk tobacco products.
Foundational Standards is a historical stream of the CDISC Interchange. This time the focus was given to the adoption of CDASH and how it could improve the process while saving time and money. In my presentation, I tackled the importance of planning traceability upfront. This should be considered in each step which involves data-processing- from the time data are collected, migrated into ADaM and later on analysed and presented in the CSR. We also discussed what happens when traceability breaks down. We''ll address the issue of traceability more fully in a future blog.
The future vision of CDISC was discussed in a plenary session presentation. Simplification of the use and adoption of standards will be high on the CDISC agenda moving forward. In addition, we can look forward to a continued focus on TA development and automation through a proper use of metadata from start-to-end.
At Cytel we have extensive experience working with CDISC standards and the planning and implementing of large migration projects for submissions. To read more about one of our data migration and NDA submission projects click below.