There’s a saying around here: If you don’t like the weather… wait 10 minutes!”. Pre-COVID, I was fortunate that my work allowed me to travel, and especially around the US. This is a phrase I’ve heard several times and everyone thinks it’s unique to their area, but it’s actually pretty common.

I was reminded of the phrase this week as it seems pretty applicable to the world of SEND. Those of us who’s world revolves around SEND have needed to get accustomed to change. Things can change rather quickly, and sometimes uncomfortably; but they do keep changing.

It’s only been 6 years since the guidance was published in 2014, yet in that time so much has changed. SEND is mandated for submission and a whole new industry – and in some cases brand new companies – have sprung up to service that need. My SOT presentation this year was entitled “Is the tail wagging the dog? Tackling the impact of SEND” looking at 3 keyways that SEND has drastically changed everything from data collection through to data analysis. We see new Technical Conformance and Business rules continually being published from FDA and this year saw a new SEND Standard hit the data standards catalogue (SENDIG-AR v1.0). Just last week saw the Federal Register Notice for a Fit-For-Use (FFU) Pilot for SENDIG-DART 1.1 (that’s SEND for Repro studies, incase you are not familiar with the IG). This sets us on the path to seeing Repro Studies being required in SEND by FDA.

So, we’ve got used to change. We’ve learnt to be the type of people that are comfortable adapting. Comfortable embracing the new. Comfortable with having our horizons redrawn and our thinking challenged.

Last week threw up the latest seismic shift. It wasn’t the FRN about Repro studies, it was actually a passing line on a single slide of an FDA Public Meeting changed everything. One bullet point hidden amongst many others seemed to tare up the rule book. Am I being overly dramatic? Perhaps, but I know I’m not alone in feeling this way.

Wednesday morning, I’d just published my previous blog where I talked about the question “Does my study require SEND” and how answering that simplest of questions, seemed overly complex, but ultimately led us to the eCTD and how I’d praised the FDA in using the eCTD structure as a good, clear indicator to determine exactly which studies are in scope and which are out of scope.

I published it just before the FDA Public Meeting which then included the line “The placement of a study into the eCTD does not determine the SEND requirement”. It’s since become clear that the agency has always considered SEND to have wider scope than just a few key eCTD sections. FDA reviewers are embracing SEND and see it as massively useful. They do not want the requirement to be limited in this way. They are requiring more SEND. The message is clear: “If your study could be represented in SEND, then it should be in SEND”.

This begs the question: How do I know if my study could be represented in SEND? Answering that now it takes a lot more SEND expertise (otherwise known as SEND-nerdiness!). This new definition is certainly a lot more difficult to work with than simply referencing the eCTD sections.

FDA may have always had this understanding of the scope, but it’s certainly taken industry by surprise. This means that FDA clearly expect more studies to be rendered in SEND than they are currently seeing.

So, it feels like this is the latest, in a long line of changes where SEND is further impacting industry. As sizable as this change is, I know we’ll adapt. We always do.

Till 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.

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