SEND 4.0 – Just how big is this change going to be?

It was going to be called SEND 3.2 but now it’s going to be called SEND 4.0. Why the change and does it really matter? As you may have guessed, the change is due to the scope of the updates. The addition of several new domains and data types mean this is seen as a more significant update to SEND than previously imagined. Not only that, but we will see the removal of a couple of domains too.

So, let’s break down the scope of changes for SEND 4.0.

We’ll start with the removal of a couple of domains. Firstly, Bodyweight Gains (BG) is being dropped. With the currently available tools offering such flexibility in the presentation of the bodyweight data in BW, there’s been little need for the BG for quite some time. The FDA’s Technical Conformance Guide was updated a while ago to state this, so it’s only natural that its days in the SEND IG are numbered.

The tumor findings (TF) domain is also going away, but this one is a little more complex. It is disappearing as a separate domain, but the crucial piece of data it holds, that’s the time in days to detection of tumor, is going to move to the Microscopic Findings (MIDETECT will replace TFDETECT). I think we can all agree that this is a simpler and more elegant solution.

So, BG and TF are leaving us, but we are getting 5 new domains:

• Pharmacokinetic Input (PI) is going to give us a place to present the data that were used as the input for TK analysis.
• Scoring Scales (SX) will provide a domain to list out all available values for any test that uses a scoring scale. It paves the way for future nervous system data, while in this version, providing useful context for certain lab tests.
• Cell Phenotyping (CP) and Immunogenicity Specimen Assessments (IS) are going to be introduced.
• Also, there is a new domain for Ophthalmic Examinations (OE). This OE domain will take ophthalmology data that are currently presented in the Clinical Signs (CL) domain, and instead give them a more appropriate home in their own domain.

After the publication of SEND 4.0, there will be subsequent guides for both safety pharmacology, and dermal and ocular studies. The OE and SX domains are both intended for use in those future implementation guides.

So, there we have an overview of many years of work by a vast number of volunteers, all described in around 500 words. I hardly feel that I’ve done it justice. As we near publication and eventual regulatory requirement, I’ll dig into each of these in more detail and give you my own thoughts and opinions. Well it wouldn’t be a blog without that, would it?

And on that note, I’ll leave you my one controversial, parting thought: having discussed what is ‘in’ SEND 4.0, it still pains me that the Nervous System (NV) domain didn’t make the cut. After all these years, we still will not have a proper home for our Functional Observation Battery (FOB) data. Maybe that particular rant can fill another blog some other time.

‘til next time

Marc