Well Happy New Year one and all!

After saying a final sayonara to 2020, I’m sure that you, like me and the rest of the world are hoping that 2021 ends up being so much better than its predecessor. That’s got me thinking about what’s happening with SEND in 2021.

As discussed a couple of postings ago, the recent Federal Register Notice specified the coming February 26 as the date by which Sponsors must register their application to participate in the FDA’s Fit-For-Use pilot for SENDIG-DART. The expectation is then that March through May should see participants creating datasets. Later in the year, the findings of the pilot together with any recommendations, should be made public by FDA.

As usual, we can expect FDA publishing Technical Conformance Guides in March and October again. Will they use this to further clarify their position on requesting that more studies should be submitted in SEND format (See this posting for more details)? Will we see updates to reflect the needs of CBER and that center’s recent pilot of SEND? I’m thinking specifically here about representing ADA in SEND.

I’m sure we’ll see an update to the Technical Rejection Criteria too.

Somewhere around the end of the first quarter, we should finally see the publication of SEND 3.1.1 from CDISC, with its associated Conformance Rules. For me personally, this will be a huge milestone. SEND 3.1.1 is change to the PC and PP domains and the reason this means so much to me personally, is that at CDISC, I lead the SEND PC/PP team. We have been working on this change since about 2017.

In its plainest terms, this change is simply that the PC domain has two timing variables moved from Perm to Exp while two others moved the other way going from Exp to Perm. Also, the PCUSCHFL variable was added as permissible in order to make it consistent with the other findings domains

SEND 3.1.1 has completed 2 rounds of public review, so the actual changes have been public for a while, but if you’d like further information, then feel free to drop me a line.

While on the face of it, this seems only a very slight change, the team have also completely reworked all of the examples and supporting text in order to be more applicable for nonclinical data. So yes, only a minor tweak to the actual variables, but a significant reworking of these sections of the IG and something that should improve the IG’s usability in this area.

2020 was the strangest of years. Here’s hoping that 2021 is better for us all.

Till the next post


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.