As we approach the holiday season and the eventual end of another year, I’m again thinking of how fast this year has passed. Also remembering childhood times when Christmas seemed to take forever to arrive. Now it seems I barely catch my breath and another year flies by. So yes, time is most definitely relative. As I look out of the window at the first dusting of snow, it seems truer than ever that the rate at which time passes, very much depends on your frame of reference.
The same is true of the world of SEND. I often hear the idea that SEND is moving too quickly. We barely get time to implement one change when another arrives. We are still adopting one standard when another is being forced on us. I mean, I know various organizations are still battling with the tighter control of the Microscopic Findings introduced in SEND 3.1, yet we already have SEND 3.1.1 published and now CDISC are talking about the SEND 3.2 with a whole raft of new domains and concepts to adopt.
I hear that point of view and while I have some sympathy for it, for me, SEND seems to move at an almost glacial pace. Take SEND 3.1.1 as an obvious example. This minor update addresses a crucial issue found with the Pharmacokinetics (PC) domain in SEND 3.0. Back in 2017 a small, expert team assembled to address this. Very quickly the solution was defined, yet it took until 2021 just to be published and still is not referenced on the Data Standards Catalogue.
In another example, as I’ve discussed here before, I joined CDISC back in 2012 to help work on the SEND standard for Reproductive Toxicology. It will be 11 years later before it finally becomes required in 2023.
Nervous System data is another area of disappointment. The domain was drafted back sometime around 2016 but it didn’t make the cut for SEND 3.1. Though it has examples, Controlled Terminology and Conformance Rules, it’s not making the cut for SEND 3.2 either. It’s currently scheduled for a tentative late 2025 publication, meaning we are looking at 2029 as the earliest that Functional Observational Battery and other CNS tests are going to be required in SEND. For an effort that began prior to 2016, this seems an unbelievably slow rate of progress.
The examples cited here are just some of many. My organization invests a huge amount of volunteer hours in CDISC because we honestly believe that the development of the SEND standard really does fit with our company vision to help our customers bring life enhancing products to market faster. We currently have more than 20 individuals giving time to CDISC, many of whom are actively leading teams. So, I personally feel the frustration of the snail-pace progress of SEND, but, like the changing of the seasons, the pace of progress is very much dependent on your frame of reference.
Till next time,