Karl Wallendszus

How long have you been volunteering at CDISC? 

From late 2020, when I joined the Analysis Results Standard team.

What encouraged you to volunteer your time and expertise with CDISC?

I attended a webinar about the plans for the new Analysis Results Standard and was inspired by the idea. I felt it had the potential to fill a gap in CDISC standards and take us nearer to truly end-to-end standardization. At Oxford Population Health we had already developed our own way of handling and re-using analysis results, but I could see it would be preferable to have a standard way of doing that. It would make a number of other things easier, including sharing results with collaborators. Also, it’s not that common to have an opportunity to help develop a brand new standard, as opposed to update existing ones. My managers were happy for me to devote some time to it, as it meant our department would have a voice in the development process.

What did you want to be when you grew up?

When I was very young I wanted to be a zoo keeper, as I loved animals. As I got a bit older that evolved into an interest in biology, and I ended up studying zoology at university, without any idea of what I would do afterwards. While there I first encountered programming (this was in the early 1980s so I hadn’t done any at school) and caught the bug.

How did you begin working in clinical research?

The careers service at university pointed me to a master’s degree in “biological computation”, which covered quite a lot of programming as well as some maths and statistics, all geared toward biological applications. As a result of that I got a job in a small academic group who ran clinical trials in childhood cancer. After a few years I moved to Oxford University and joined one of the units that now make up Oxford Population Heath. We run large trials in common diseases, many of them in collaboration with industry partners. Some of them result in regulatory submissions, and that’s why we first started using SDTM and ADaM in around 2010. Back then we were quite unusual as an academic institution in the CDISC community, but I’m pleased to say that has been gradually changing.

You are working on the release of the ARS, version 1.0. What are you excited about with this release and what updates do you think the user community will find most useful?

We’ve developed it with a number of different use cases in mind, but for me the important things I hope it will facilitate are the automation of running analyses and the re-use of the same results in multiple displays. At the same time it will make it much easier to trace results so you can see exactly how they were generated. As with most CDISC standards, it’s all about the metadata!

Please provide a tip that someone would find helpful in working with CDISC Standards.  

Volunteering for a CDISC team is a great way of getting a deeper understanding of how a standard works. Team members are from different backgrounds and have different perspective, and that helps you understand better why a standard is the way it is. Having just taken part in the ARS Hackathon, I can also recommend that if you want a deep dive over a limited period of time.