This month marks the anniversary of the start of the requirement for SEND. It has been 3 years since SEND became required for INDs and 4 years since it’s requirement for NDAs. In our world, that really is not a long time. Yet, for many of us, SEND has completely changed our world. So, in this blog post, I’d like to take a quick look at how much has changed and how much of that was unexpected and offer some insights on how to best deal with that change.
There was a time when we used to hear some people say things like:
- SEND is just an electronic representation of the Study Report Appendices for the Individual Animal Data Tables
- If you didn’t collect those data before, you won’t need to start to collect them just for SEND
- SEND is just a file format
I’ve even said some of those things myself. That first line was almost my mantra at conferences in the early days.
Yet today we are electronically capturing more data than ever before, and we seem to be making all manner of changes to accommodate SEND. So, what happened? How big of an impact is SEND having?
A director at a large CRO, once told me:
“SEND has had the biggest impact on the industry since the introduction of GLP”
The magnitude of that statement has always stuck with me.
SEND has actually impacted the entire process from placing a study at a CRO; then impacting how data are collected; dictating changes to lexicons to make them more SEND friendly; electronically capturing data that previously may have only been in an SOP or noted in the study report; providing new tools and methods for how studies can be analyzed; and right through to giving standardized electronic data a value beyond just the submission.
Obviously, that’s far too much to tackle in one blog post, so here I’ll look at how SEND impacts the decisions when placing a study with a CRO and I’ll return to the other topics in future posts.
Sponsors now need to understand their CRO’s capability and standard practices around SEND to ensure that both parties have aligned expectations. For some sponsors, this can be a challenge as they do not have in-house SEND expertise, and therefore may not know what their expectations around SEND should be and are unclear about what the CRO is providing to them and if it meets their needs.
Some CROs have a policy stating that sponsors must state their SEND requirements upfront as trying to accommodate them retrospectively may be quite challenging (to put it mildly), so it is important that such things are discussed and agreed from the outset. To be fair to the CROs, this is a fairly understandable position and at this point it’s worth noting a line from the FDA’s Technical Conformance Guide document:
“The ideal time to implement SEND is prior to the conduct of the study as it is very important that the results presented in the accompanying study report be traceable back to the original data collected.”
The FDA themselves are advising that we don’t let SEND become an afterthought. We are advised to consider SEND prior to conducting the study.
Also, what if you are a Sponsor with an established relationship with one of the smaller CROs who does not have any SEND capability? You may have been advised to stop using this CRO in favor of placing studies at one of the larger CROs; a CRO with an established track record in SEND. While on the face of it this may seem like sensible advice, you may find this unpalatable due to rising costs, or the smaller CROs may have specialism in a certain area; or simply you may have an established relationship and work well together. Let’s face it, nobody wants SEND production to dictate which CRO they use, yet the SEND datasets shouldn’t e overlooked as they are the very data that the FDA will use in their review.
So, at this point you may be asking yourself:
- What if I don’t even know what my SEND requirements are? How can I discuss them with the CRO?
- What do I do if I’ve left it too late and my study is already complete?
- What do I do if I want to work with a CRO who cannot provide SEND?
Don’t worry, that’s why we’re here. Uh no, a commercial is coming… Instem provides SEND conversion, verification and consultancy services; and yes, that even includes creating SEND datasets from a final PDF study report. I’m not a salesperson, but we are the leading provider of SEND services with the foremost experts (sorry for the advert as I couldn’t resist, and our Marketing VP will love it).
Seriously, as always please email me with comments, questions or even disagreements at firstname.lastname@example.org
Till next time…