In Part 1, I went into the detail of what the new SENDIG-DART standard covered; and now I’ll conclude by describing what’s involved in ensuring the industry is equipped with the necessary tools and services in order to successfully participate in the FDA’s Fit For Use (FFU) pilot for SENDIG-DART.
The view from the trenches
My involvement, 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.
These are the tools and the services, on which the industry depends. Fortunately, earlier this year, we had some indication from CDISC and FDA that this pilot was coming. This forewarning was invaluable because the software can take the best part of a year to develop as this needs to be done while still developing additional functionality and improvements for supporting SEND 3.1. This new DART functionality comes straight after we have just completed work for two key SEND 3.1 items: supporting the creation and consumption, firstly of Custom Domains; and secondly, of Latin Square Safety Pharmacology studies. It felt like there was not time to draw breath before we began adding the 7 new DART domains. As solutions director, arguably my most critical task is evaluating and prioritizing our development plans. Over the past few years, we prioritized SEND 3.1 over SENDIG-DART, even though both were published around the same time. This year, we have prioritized SENDIG-DART over SENDIG-AR and have had to delay some of the myriad of other improvements that we’d love to implement to get us closer to that elusive ‘push button SEND’. It’s a difficult choice to implement support for a standard that is likely to not be required for at least another 3 years. That’s a huge investment for a vendor, to create something that will get used briefly for a pilot, but then sit dormant until it eventually becomes a submission requirement.
Getting ready for the FFU has been challenging, at times difficult but also wonderful to finally see this standard come into reality. Yes, for me this is a journey that started in 2012, but finally we have the tools to create the datasets. Finally, we can provide the services for DART that the industry will rely on to create and verify these datasets.
Implementing such solutions puts the standard under pressure and we see just how robust it is. I discover there are one or two items that could have had a clearer definition. One or two concepts that could have been better realized. Now I’m seeing things from the other side. Actually, I’m thrilled to finally have these datasets. We imagined them in CDISC meetings years ago and now they are a reality. Despite now knowing some improvements I’d like to see in the SENDIG-DART, the truth is that it does hold up to the pressure and I’m confident that this FDA FFU pilot will be very successful. It’s been a long, and at times difficult road, but I’m really excited about it.
For reference, the Federal Register Notice is here:
Yes, this 2-part posting was a little more technical than usual and I brought us all into the weeds, even listing and describing actual domains. For my next post, normal service will be resumed, and you’ll be treated to my usual ramblings and single-minded opinions on the impact that SEND is having on our industry, looking at the whole process from placing a study at a CRO through to reporting and analyzing the study results.
As always, if you want to continue this conversation – drop me a line at marc.ellison@instem.com
Till next time
Marc
Sensible SEND Blog 