I met up with a fellow CDISC volunteer at the Society of Toxicology meeting recently, and during the general chit-chat, he mentioned that he had reviewed SEND v4.0 but wasn’t really considering its impact yet. Me, on the other hand, I told him it was already starting to keep me awake at night.
So, am I worrying too early? SEND v4.0 hasn’t even had a public review yet, and even if it passes that reasonably unscathed, we are still looking at 2026 before publication. Then we have the guesswork of if, and when, it could be adopted by FDA, or any of the other regulators that are taking an interest in SEND.
Honestly, even the most aggressive estimates put it at 2028, with the far more conservative thinking it won’t be until at least 2030. This conversation made me realize that the point that we really need to sit up and take notice of SEND v4.0 will vary depending upon our situation.
As a vendor of tools and services supporting the nonclinical industry, I will be at the sharp end of the impact. Industry relies upon such tools, so we need to deploy them in good time. So, code development as soon as SEND v4.0 is published, which means planning and design are already underway.
So that’s the point of view of a vendor. However, would a sponsor also need to start planning so early? Well, probably not. I’d advise any sponsor to have good visibility on the content and scope of v4.0, particularly as more of their studies may potentially come into scope. But, they probably don’t need to be particularly concerned with implementation just yet, as it’s not unreasonable to simply assume that CROs and other service providers will have their SEND v4.0 offerings in place in time for any requirement.
Talking of CROs, they would be well advised to invest effort in reviewing SEND v4.0 when it comes out for public review later this year. Consider how this new version dictates how we should be representing our data, and please provide CDISC with valuable feedback highlighting any pitfalls.
CROs will have far more data and study types that are now modelled in SEND. Begin considering the systems that collect and report those data and how they may be connecting to your SEND tools. Obviously, talk to your SEND tool supplier sooner rather than later.
I guess the point of this blog is to encourage everyone to take the public review of SEND v4.0 seriously. Beyond that, how long we wait until we really need to start worrying depends upon which particular link in the chain we are. Oh, and I didn’t even mention the impact of any potential FDA Fit-For-Use pilot. Perhaps the subject of a future blog.
‘til next time
Marc
