Back in 2020 when the idea of blogging about SEND was first suggested to me, my initial thought was “What is there to talk about?”. This is now my 61st bi-weekly post. If you have been with me along that journey, then you will have spotted a few recurring themes. I like discussing scope, future …
Continue reading “Is there really that much to say about SEND?”
Recently the question was asked “Are bone length measurements in scope for SEND?”, which leads to another interesting question: “Who gets to decide what is in scope for SEND?”. There are two parts to this. Firstly, which data were intended to be covered by the various CDISC documents, and secondly, which data do FDA require …
From my earliest introductions to SEND, one of the things that surprised me most was just how loose it was. It seemed that at every turn there were choices. The phrase “The sponsor chose…” occurs throughout the implementation guide when describing a particular representation of data. Several years ago, I was presenting at the Society …
Recently, more and more, I’m being asked my opinion about the scope of SEND and if a certain study or even a certain endpoint should be provided in SEND. Clearly, I’m referring to data which do not have an obvious example in the SEND IG. However, the lack of example cannot be the defining criteria …
Being the first post of the year, I thought it would be good to consider what the year ahead looks like for the world of SEND. The obvious place to start is looking at the standards that are going to become required by the FDA for submission. March will see SEND 3.1 become required for …
Greetings of the season everyone! As this will be my last post of the year, I thought it would be interesting to look back at a few of the topics featured in the blog during 2022. Back in January I was hoping to see the publication of the SEND standards for juvenile toxicology (SENDIG-DART 1.2) …
There have been rumors of a proposed Nervous System domain (NV) for many years, yet still nothing has been published and it’s not listed in the content for SEND 4.0. So, just what is going on? At the recent joint FDA and CDISC SEND meeting, the full scope of SEND 4.0 was presented, and so …
Continue reading “Nervous System Tests and SEND: what’s going on?”
It was going to be called SEND 3.2 but now it’s going to be called SEND 4.0. Why the change and does it really matter? As you may have guessed, the change is due to the scope of the updates. The addition of several new domains and data types mean this is seen as a …
Continue reading “SEND 4.0 – Just how big is this change going to be?”
There’s an argument I occasionally hear that absolutely infuriates me. It’s usually some variation on the line, “The FDA doesn’t care about the quality of SEND, so why should I?” I know I’m paraphrasing, and probably stating this a little too bluntly, but it’s based on the fact that the FDA’s Technical Rejection Criteria (TRC) …
Last week was the Fall 2022 CDISC meeting. As usual, the highlight of the meeting was the public joint presentation between CDISC and FDA. With each event, cross study analysis has slowly become more of a focus. This time, there were multiple presentations referring to this topic and the opportunity to use SEND beyond just …
Continue reading “Virtual Control Groups and more – Update from the CDISC Fall meeting”
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