It’s the start of the new year, and so it’s only human to look to the year ahead with a sense of optimism. So, it will come as no surprise that my first blog post of the year looks at what we may expect to be happening in the world of SEND.
Our first major milestone comes on March 15th, which is the date that triggers the FDA requirement for Genetic Tox studies to be submitted in SEND. Here we are talking about in vivo micronucleus and comet assay data. This will come as the most significant increase in the scope of the requirement since SENDIG-DART v1.1 became a requirement in March 2023.
Dataset-JSON is another topic that’s going to get a lot of attention this year. As an eventual replacement for the outdated XPT format of the current SEND files, Dataset-JSON represents a significant step forward for the standard. Version 1.1 was published by CDISC in December 2024 and has support from the FDA who, together with CDISC and PHUSE, have been involved in the pilot of the new format.
While Dataset-JSON is not currently on the agency’s Data Standards Catalogue, I’d highly speculate that we’ll see the format becoming supported in 2025.
SEND v4.0 is still in development, but this year should see its formal public review. This is the single biggest change and increase in scope that I’ve ever seen to the standard. I’ve stated this before, but it’s worth repeating: the new studies and/or data types that will be added to SEND v4.0 include:
- Immune System Tests
- Cell phenotype
- Dermal
- Ocular
- Assessment of sexual maturity during microscopic examination
- Assessment of reproductive cycle during microscopic examination
- Microscopic targets staining assessment
- Pharmacokinetic input data for TK analysis
- F.O.B.s and CNS tests
In addition to this, there are other far-reaching changes coming, like a reworking of depicting baseline values in order to better accommodate specialist study designs, like the Latin Square.
This version first needs to complete a full internal CDISC review and update, so I’m guessing we are looking at the second half of the year for public review.
CDISC’s Open Rules Engine known as CORE continues to be developed and will eventually revolutionize how datasets are checked for conformance and quality, but I doubt we’ll see this impacting nonclinical in 2025. At the current rate, I’d expect that’s more likely to impact us in 2026.
However, September 2024 saw Swissmedic begin to accept SEND datasets as part of their submissions as they say “the use of SEND data sets enables effective and efficient analysis of data according to the latest state of science and technology.” Will 2025 see other regulators take more of an interest in SEND? As we have also seen EMA running a pilot, I’d say there’s definitely an increasing appetite for SEND beyond FDA.
As usual, throughout the year I’ll be posting updates, thoughts and opinions about everything to do with the world of SEND.
‘til next time Marc
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