For most organizations, the FDA’s SENDIG-DART v1.1 Fit-For-Use (FFU) pilot started with the Federal Register notice being posted back in October 2020. For some of us it began earlier when it became apparent that the FDA had an appetite to adopt the SEND standard for Developmental and Reproductive Toxicology (DART). That meant a pilot was inevitable.
Fast forward several years to 2022. We can now see what lessons were learned from that pilot as CDISC have published the details here on their wiki. There is a good deal of material to digest. There are the study data, study reports, FDA reports and a wealth of supporting documents. However, the learnings from the exercise are summarized in a set of PowerPoint slides which were compiled by CDISC. Still, that’s 21 slides crammed with information and recommendations which is a lot to consume. Yet it is very timely considering we are less than a year away from the standard becoming a regulatory submission requirement.
So, for those implementing SENDIG-DART v1.1, I’ll highlight just one area that seemed particularly troublesome to some of the organizations participating in the FFU pilot: The representation of the details of the timings of the results.
While for a General Toxicology study, the study day and dose day are practically synonymous and interchangeable, this is not typically the case with a DART study. Here we have the Dose Day, the Study Day and the Gestation Day as 3 independent concepts. They may happen to occur on the same calendar date, but they are independent. Of these, the Gestation Day is the concept typically used to report data. Obviously, anyone coming to SENDIG-DART from a background in SEND 3.1 is going to find such a concept quite jarring. In General Toxicology, Study Day is king, yet in DART it takes a back seat as the repro phase day – in this case the gestation day – takes precedent for the reporting and analysis. This is something that is described in the SENDIG-DART, but not always understood by all FFU participants.
While there are many details noted and points to be considered in the FFU learnings, I wanted to highlight this issue as it is so crucial. Like many of the other issues highlighted by the pilot, the guidance and instructions are in the SENDIG-DART but are not always well understood. Therefore, it seems to me that the SENDIG-DART is even more tricky to interpret than the main SEND Implementation Guide. Yes, SENDIG-DART includes everything from the main guide and all the pitfalls we’ve all spent years learning to navigate, but DART now brings with it its own set of complications and subtleties. I’m strongly recommending that any organization that is implementing SENDIG-DART pay close attention to every part of the Implementation Guide. Every detail is important and not to be glossed over. For many organizations, perhaps those with an already stretched SEND team, or with a low volume of DART studies, I’d go as far as to suggest that they shouldn’t look to implement SENDIG-DART themselves, and instead consider outsourcing it to an organization already experienced and capable of supporting this tricky standard. However, for those that are implementing, I’d advise them to take advantage of the training, support and assistance that their partners can provide.
‘Till next time
Marc
Sensible SEND Blog 