This week’s blog will cut straight to the chase: The scope of SEND 4.0 has significantly increased of late, and so the timeline has been impacted too. That means in the next update to the main Implementation Guide, we are getting 8 new domains:

  • Cell Phenotyping (CP)
  • Immunogenicity Specimen Assessments (IS)
  • Ophthalmic Examinations (OE)
  • Pharmacokinetic Input (PI)
  • Scoring Scales (SX)
  • Nervous System Test Results (NV)
  • Skin Test Results (SK)
  • Genetic Toxicology – In Vivo (GV)

Since my introduction to SEND back in the SEND 3.0 days, I don’t think we’ve ever introduced that many new domains. SENDIG-DART 1.0 came close with 7 new domains, but this sets a new record. Also, I’m taken back by the breadth here. Unlike SEND 3.1, whose new domains were all focused on safety pharmacology, this new version is hitting multiple targets.

In addition to the domains, there are 16 new variables as well as a change to our nonstandard variables which are getting promoted to standard variables. Many will be glad of this last point as it should significantly reduce our reliance on supplemental domains.

Another significant change that’s worth mentioning is that Microscopic Findings (MI) will see new variables and an increased scope with additional tests to cover Sexual Maturity, Reproductive Cycle Phase, Targeted Staining and Macroscopic Examination Follow-up. Also, the Tumor Findings domain is being retired and so for carcinogenicity studies, the relevant data such as the time to detection, will now reside in MI.

Oh, and we should finally see the end of Bodyweight Gains in SEND as the BG domain is also to be retired.

Much of the above has been known for some time, however at the recent FDA public meeting, the changes for nervous system and skin tests were formally announced along with the inclusion of in vivo genetic toxicology. The addition means a further delay to the timeline which now is estimated to be published on 1st April 2025. I’m sure the fact that is April Fools Day is purely a coincidence!

At this point it seems pretty pointless to estimate when it might become a submission requirement, except to say that we have several years from now to get to grips with the significant implementation burden that this will bring.

The guide is due to go on public review this coming August, and I’d highly recommend any regular reader of this blog to set the time aside to go through this new implementation guide. It will be our first real opportunity to start to assess the impact on our individual organizations.

Does it mean more studies are going to come into scope for SEND? Yes, but it also means some significant changes to those studies already in scope. We are going to need new tools and processes. It’ll be a little scary for a while and I’m sure there’ll be some bumps in the road, but this is going to be a huge improvement to SEND and another step forward in getting more nonclinical data into a standardized format.

‘til next time

Marc

Published by Marc Ellison

Self-confessed SEND nerd who loves geek-ing out about everything to do with SEND. Active CDISC volunteer and member of the CDISC SEND extended leadership team. Director of SEND solutions at Instem responsible for all our industry leading SEND products and services.