It’s here. It’s finally here. It’s actually real. This is going to happen.
This is part 1 of a 2 part mini-series, hang in there…
I’m referring to the FDA Federal Register Notice for the pilot of SENDIG-DART (that’s SEND for Reproductive Tox). It’s a new SEND standard, and the FDA are going to run a Fit-For-Use (FFU) pilot throughout 2021 as the first step in the processes of adoption and ultimately making it a required standard. Excitement and trepidation in equal measure.
For me, this was the slippery slope that ultimately caused me to be consumed by SEND. Back in 2012, I was asked to contribute to the development of the standard due to my background in developing the Repro Tox functionality in our study management solution, Provantis®. Four years later, in 2016, the standard was published – incidentally, within about a month of SEND 3.1 also being published. That actually makes for an interesting comparison as SEND 3.1 widened the scope to include both Safety Pharmacology studies and the use of Custom Domains for non-modeled data; yet SEND 3.1 has been required now since March 2019 (though 2020 for IND submissions) but SENDIG-DART has just quietly sat in the background, waiting for its day in the sun.
Time to Get Technical
I hope you are sitting comfortably, because this is where things get a little more technical than I’d normally include in a blog.
Let’s start by answering the burning question: What’s in SENDIG-DART v1.1?
It only covers Embryo-Fetal Development (EFD) studies. It doesn’t support Fertility, Juvenile Tox or any kind of multi-generation study. So, it expects females to arrive on study already pregnant and to be dosed during gestation and the study ends at C-Section. As far as DART is concerned, it’s just about the simplest and most common study in the package.
To support EFD, the standard itself include 7 new domains:
- 2 Trial Design domains: Trial Stages and Trial Paths – stages and paths are to Reproduction, what Elements and Arms are to treatment.
- 1 Special Purpose domain: Subject Stages – equivalent to Subject Element but for Reproduction stages instead of Treatment Element
- 4 new findings domains:
- Implantation Classification: IC – a little bit like demographics for the contents of the uterus.
- Nonclinical Pregnancy Results: PY – Results against the female like the Pregnancy status, Pre and Post implantation loss
- Fetal Measurements: FM – Results against individual fetuses, like the Fetal Weight
- Fetal Pathology Findings: FX – Examination data for each fetus
In addition to this, SENDIG-DART v1.1 inherits everything from SEND 3.1, so all the existing domains are included (BW, CL, LB etc) though they have been enhanced with the addition of Repro Timing Variables, so date/time of a result is shown as a number of days of Gestation as well as still showing Study Day.
Also, additional test codes are available in BW for Gravid Uterus Adjusted Bodyweight.
Come back in 2 weeks for Part 2, here’s an opening excerpt:
The view from the trenches
From co-authoring the standard through to developing software and services for producing SENDIG-DART datasets, gives me a fairly unique point of view when it comes to the pilot.
As always, if you want to continue this conversation – drop me a note at marc.ellison@instem.com
Till then
Marc
Sensible SEND Blog 