CDISC Interchange

Vaccines, COVID-19, Biomedical Concepts – The CDISC EU Interchange was dynamic and well received.

Getting a conference together is hard but putting on a good virtual conference is harder. You don’t know if people are paying attention, you can’t see them and so on. But if you get the content right, people will engage.

Jesper Kjær, Director of the Danish Analytics Centre

The CDISC Interchange opened with an outstanding presentation by Jesper Kjær , Director of the Danish Analytics Centre at the Danish Medicines Agency. Denmark might be a small country, but it has a highly respected medical research community and the work they are doing on using standards and managing new data sources is world leading. Jesper Kjær’s presentation focused on the way that CDISC standards ensure that data can be collated, and informed and detailed research can be conducted.

“There is no need to discuss data standards, they’re already there!”

He also talked about the increasing value of Real World Data and how important that was during the COVID crisis, particularly when conducting safety signal analysis for the vaccines. Questions at the end of his presentation were varied: from GDPR to standards mappings. It was good to hear him say, ‘Mapping between the standards is risky,’ and that he considers the drive towards using Biomedical Concepts will be, ‘Much better.’

Danish Medicines Agency & Biomedical Concepts

Science Will Prevail

The State of the CDISC Union Update is always an interesting presentation. This year, enhanced by the arrival of the new CDISC CEO, Dave Evans, there was clear focus on delivering standards and increasing the strength of CDISC’s membership, introduction of new initiatives and building further partnerships and collaborations. Peter van Reusel, CDISC CTO, talked about how Biomedical Concepts are placed at the centre of the new standards developments and the introduction of new technologies and APIs to link to the standards.

Science Will Prevail

Perhaps the most detail came from Bess LeRoy, who described how standards releases will change in the future. There is a desire to create better links between the standards, allowing for increased traceability, particularly between SDTM and ADaM. Overall, the message was a positive one, look for more releases, get involved with the CDISC community and be part of the change. Importantly, it was good to return to a message that science is at the heart of the drug development process.

ADaM and Ontology

S-cubed have supported CDISC since the company was founded in 2007 and, one of the most recognisable faces in the early days of CDISC and an authority on ADaM is our own, Niels Both. Niels and Anna Bladström closed out the first day of the conference with their presentation on Traceability of ADaM Time to Events Data in Oncology Trials. Anna’s detailed presentation covered suggestions to obtain traceability by using the analysis data for response parameters (ADRS) also as an intermediate dataset for time to event parameters in ADTTE.

You can download their paper and slides to read more, just follow the link.

CDISC 360 Update

The CDISC 360 update on day 2, was a fascinating insight into the future of CDISC standards and recognises the need for digitising CDISC knowledge and ensuring it is future proof. Peter van Reusel opened with, ‘What’s in it for me?’. He described the 4 Pillars of the CDISC standards: Complete (or End to End), Enrich, Extend, Collaborate. Underpinning those standards are Biomedical Concepts. S-cubed has advocated for BCs over the last few years, alongside the team at A3 Informatics. Peter made clear that there should not be variability in the standards and there needs to be a common understanding of how we manage our data. He explained that using define.xmls, CDISC will begin building a library of BCs. In the long term, there will be a biomedical concept layer and a presentation layer with the intention of providing true end to end standards, something that has been discussed for the last 15 years.

Sam Hume’s presentation focused on the technical activity that takes place behind the scenes. He described the need for developers to be able to create more tools and APIs to link into the CDISC Library. This is an area of need for all those working in the software world and also to ensure that those using the standards can access them quickly and easily. The new CDISC Open Source Alliance (COSA) is being developed to bring the community together quickly, in order to build more open source tools and create real interoperability. One of the questions was interesting and focused on the use of Supplemental Qualifiers – as Sam so delicately put it, it’s time to ‘standardise the non-standard!’.

Finally, Dave Iberson-Hurst, of A3 Informatics, introduced Biomedical Concepts in detail. For many years, those of us who have heard Dave speak, know that he can often see beyond the problem to real world solutions and is not bound by the ‘rules’ of engagement (for want of a better expression). He began by explaining the relationships between the data and metadata using his LEGO metaphor of building blocks that fit together in multiple different ways. The idea of a BC as a unit of knowledge is the same as what we might call an observation. Bringing BCs into the core of the CDISC standards reduces the need for ‘mapping’ or indeed removed mapping completely, if the same BCs are used across the clinical lifecycle. Of course, to bring about such change industry will need better definitions. In fact, a good way to start, is by creating the Therapeutic Area User Guides (TAUGS) based on BCs.

4 Pillars, Behind the Scenes, BCs

Development of COVID-19 Vaccines

If you didn’t wait to watch the final presentation at the end of the day, you missed a fantastic opportunity to hear, Dr Peter Marks from CBER (FDA) presenting, Facilitating the Development of COVID-19 Vaccines. Not only was this presentation full of detail about the way the vaccines had been reviewed and continued to be reviewed but it demonstrated a ‘gold standard’ approach. He was asked some tricky questions but answered all of them with the kind of reassuring knowledge, we all need at this time. If you haven’t seen it, I suggest you take the 30 minutes or so to hear what he has to say. CDISC have announced that they will make the keynotes from Dr Marks and Jesper Kjær available to the wider community, so look out for an announcement in the coming weeks.

Wrapping Up

Even though we weren’t face to face, this was a well organised and successful event. The quality of the presentations was very high, and the moderators worked hard to ensure that questions were handled well. Well done to the E3C, the CDISC events team and to all the presenters. Thank you to everyone who stopped by the S-cubed booth and please reach out, if you need support with CDISC Training or Legacy Data. Here’s hoping we are all face to face in Copenhagen next year!