Have I been repeating myself? I’ve been blogging about SEND since October 2020 and this is my 70th post, so yes, it’s unsurprising that I’ve repeated one or two ideas along the way. There are main topics that keep reoccurring. Subjects that need revisiting partly with fresh impetus; partly because no single topic can be fully examined in 500 words per post; but mainly because these are the things that keep cropping up and become the main themes of living in a SEND world.
Earlier this year, I gave a Sensible SEND LIVE! webcast which, as it sounds, was a live stream version of the blog. During the webcast, I called out and discussed what I was calling, “The Greatest Hits of Sensible SEND.” It was those topics that I’d talked about the most.
As a very brief overview, they were:
SEND Changes Everything
Audrey Walker of Charles River and past CDISC SEND lead, once told me that, “SEND has been the biggest change to our industry since the introduction of GLP.” I think that’s the most succinct description of the impact of SEND that I’ve heard. It puts it in context. To produce SEND datasets for a study, everything from planning, through data collection and reporting needs to be considered as SEND impacts them all.
SEND is Harder Than You Think
My second-ever post was called, “SEND: Why did they have to make it so damn hard?” It’s a topic I’ve revisited several times and follows directly from the idea that SEND changes everything.
The Scope of SEND
I’ve written at least 6 separate posts dedicated to talking about the Scope of SEND and touched on the subject in plenty of other posts too. I’d say it has been the single biggest talking point in the industry since the FDA added the section to their study data Technical Conformance Guide.
Beyond Compliance
Here I’m referring to the opportunities SEND brings about. Yes, the main driver for the implementation of SEND has always been the need to satisfy the regulatory submission requirement. Back in February 2021, I made a post entitled, “Beyond Compliance,” which addressed the few visionaries who are looking to use SEND for something other than submission. Since then, I’ve touched on it several times. Just recently, I attended an industry webcast where the panel believed that we’d be including virtual control groups in submission studies within 3 years and SEND was key to providing those data.
Future of SEND
The most popular posts are those that describe current requirements or upcoming changes to the standards. It seems to me that many industry professionals are still looking for clarity and direction on how to implement these changes.
If you’ve been following the blog for any length of time, I’m sure you’ll recognize several of these reoccurring themes. While it’s good to revisit these topics from a different perspective, I don’t want to be seen to just keep repeating myself. So, moving forward, I’m going to post a new blog monthly rather than bi-weekly.
‘til next time
Marc
