This is the week of the CDISC Spring SEND Virtual Face-to-Face meeting, and yes that’s still an oxymoron, but hopefully this will be the final time as future Face-to-Face meetings are planned to back in person again. While tee week mainly focuses CDISC volunteers on progressing the standard, one of the highlights of the event is the FDA public meeting on Wednesday 27th April. This sees FDA give feedback on SEND and is open to anyone wishing to attend.
For the Spring Face-to-Face there are 3 Implementation Guides being worked on in parallel as they each grow nearer completion. Personally, I’m heavily focused on the SENDIG-DART v1.2 scheduled for publication early 2023. This widens the scope of the DART IG to include Juvenile Tox studies reported by Post-Natal Day. In other words, reporting by age rather than by study day. This was in direct response to the FDA requirement in the Technical Conformance Guide:
The age of the animal at study start does not impact whether the SEND requirement applies. Dedicated juvenile animal studies that typically include multiple phases cannot currently be modelled in FDA-supported SENDIGs and therefore would not require SEND. However, when general toxicology studies (single- or repeat-dose) are conducted with juvenile animals (e.g., young, post-weaning animals), SEND is required as outlined above.FDA Technical Conformance Guide
So, our team are not going as far as modeling “…studies that typically include multiple phases” but we are providing examples to represent “general toxicology studies (single- or repeat-dose) are conducted with juvenile animals”. Of course, this can all be represented in the current version of SEND, however there are no examples of representing results in a way that allows them to be analysed relative to the age of the subject. So, aside from Developmental Milestones, this version of the DART IG doesn’t really introduce any new concepts, but simply provides examples of best practice of using the existing concepts.
Also being worked on this week is the SENDIG-GT for Genetic Tox, which models Micronucleus and Comet Assay data in SEND, also due for publication in 2023.
However, by far the most effort is focused at SEND 3.2, the next iteration of the main Implementation Guide. Many, if not all sections of the guide are being worked on in some way as the work involves dealing with a plethora of suggested minor improvements. In addition, there are a few areas receiving a more significant change. Probably the most noteworthy is the addition of new domains to facilitate the modeling of Immune System data. There are a couple of new domains being developed for these data. There’s also a new domain for TK data and significant work on both EX and Trial Design. In fact, there are many subteams busily beavering away in their own areas, too numerous to mention individually in this one blog post. Though not due for publication until 2024, this version has been many years in development already and so this feels like the final push to get the content complete so the CDISC publication process and public review can begin.
‘Till next time,