In the first part of this two-parts blog, I speak about how the European CDISC Committee (E3C) together with CDISC converted our physical event into a virtual one and was held on April 1-2, 2020. I provided a summary of the updates received from the three main health authorities - the US FDA, the Japanese PMDA and the European EMA.
This post offers an overview of the other sessions I attended at the 2020 Virtual CDISC EU Interchange. The agenda was well planned and organized. The distinguished speakers were extremely prepared and answered numerous questions after their presentations. Continue reading for further highlights from the event.
An overview of the presentations that I attended and found very useful:
“Deconstructing SDTM - Finding the Hidden Gems” by Johannes Ulander, S-cubed
Johannes Ulander’s presentation deconstructed SDTM to make us better understand the standard and enable us to produce higher quality SDTM datasets. Johannes is also my colleague at E3C, and I found his presentation very inspiring to start changing our “tabular” mindset.
“SDTM: Let's read outside the Bible” by Sandra Latorre, Business & Decision Life Sciences
In her presentation, Sandra shows us how we can find answers and good SDTM implementation examples not only from the available, individual CDISC Therapeutic Area User Guidance, but also, for example, from CDASH. In CDASH you can find areas that are not covered by SDTM, but can be applied to SDTM as well, such as naming conventions for supplemental qualifiers. Also, on a similar context, check out my presentation at 2019 PharmaSUG-China.
The entire “Tech-Enabled Standards” stream was extremely useful including live examples of using the CDISC Library as seen in the presentation by Roman Radelicki, SGS Life Sciences.
NMPA Submission (Data Submission in China)
In their presentation, Sujit Khune and Marianne Caramés, Novo Nordisk, gave us insights on what submission to NMPA (China) looks like.
For the first time, we also had a stream dedicated to medical devices. It was an opportunity for companies manufacturing these devices to share their experience. The eminent speakers included Roxane Debrus, Terumo Europe NV and my colleague at E3C, Silvia Faini, LivaNova. The session by Martin Gram and Gianluca Mortari, Novo Nordisk, brought forward constructive criticisms on the SDTM standards when dealing with data from wearable devices.
Real World Data (RWD)
This session included interesting presentations from Janssen and Zifo Rnd Solutions, highlighting the continuous evolution of RWD.
I apologize if I missed mentioning some of the other equally engaging presentations and I also regret not being able to attend presentations like the one on LOINC and UCUM by my friend and E3C colleague, Jozef Aerts, XML4Pharma. The two systems, used respectively for coding lab tests and representing units, are now mandated by the FDA. They will certainly improve the way we can collect and exchange central lab data.
To conclude, this year at E3C, we had to reduce the number of presentations and give higher preference to regulatory presentations and user showcases. However, the good news is that for the “CDISC 360 preliminary demonstrations”, CDISC has organized a separate virtual event.
Access the recording of Angelo’s presentation at CDISC-EU Interchange.
About Angelo Tinazzi
Angelo Tinazzi is Senior Director, Statistical Programming, Clinical Data Standards and Clinical Data Submission at Cytel. He is a well- published and recognized expert in statistical programming with over 20 years' experience in clinical research. The application of CDISC standards in different therapeutic areas is part of his core expertise since 2003 in particular in the context of data submission to health authorities such as the FDA and PMDA.
Angelo is an authorized CDISC instructor and member of the CDISC ADaM Team as well as the CDISC European Committee where he also manages the Italian-speaking CDISC User Network.