Looking forward to the significant events and milestones that lay ahead over the next 12 months for SEND, barring any major issues, we should see the publication of the next version of the SENDIG-DART. That is the CDISC SEND standard for Reproductive and Developmental studies and this time around will focus on Juvenile Tox in direct response to the recent TCG update.

We should also see the publication of the SEND standard for Genetic Toxicology studies. In its first version, this standard is limited to Micronucleus and Comet Assays for In Vivo studies only, but even so, this is a significant publication, further widening the scope of studies now covered by SEND.

Also, we’d expect at least two updates to the FDA’s Technical Conformance Guide (TCG), based on their standard schedule, and I’m hoping to see the addition of SEND 3.1.1 to the Data Standards Catalogue before March to start the ball rolling on it’s adoption by the agency.

The reason that I’m so keen to see this added to the catalogue is that SEND 3.1.1 arose out of a significant issue seen during the original FDA pilot. Although seemingly small, it was a serious flaw in the definition of the Pharmacokinetic Concentration (PC) domain. A CDISC team was quickly assembled to resolve the issue, and the solution was released in the next TCG in the form of guidance of how best to represent the data in this PC domain. This was back in 2017. Finally, in 2021, SEND 3.1.1 was published which brings the Implementation Guide in line with the FDA’s TCG, and hopefully in 2022 we see it added to the catalogue.

2021 also saw the TCG add the much-debated “Scope of SEND” section. Juvenile studies that include multiple phases are still out of scope, while all other juvenile studies are in scope. Yet, the SEND Implementation Guides give no examples or assistance on how to represent such studies, and in particular, how to denote the Post-Natal Day number, which is a key piece of information for many of these studies. Resolving such issues is the focus of the next version of the SENDIG-DART, and so this is another example of the standard chasing something already published in TCG.

Personally, I’m a big fan of how quickly the TCG moves and sometimes that means that the SEND standard needs to play catch up. CDISC development and publication process is slow, yet the TCG would appear to be far more agile, and so we end up in these situations of the Standard needing to chase something already adopted by the agency.

I’ve made no secret of my opinion on the slow progress of CDISC and this is another example where that seems out of step with the pace of the agency. As last year saw the publication of SEND 3.1.1 to bring SEND inline with the TCG, I’m looking forward to SENDIG-DART being brought inline this year.

Drop me a note to share your opinion(s) at marc.ellison@instem.com.

‘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.