This will be my final blog post of 2021, as I’ll be taking a break over the festive season. The season of goodwill is very apt for what’s on my mind this week.

Whether it’s media reports of how COVID-19 vaccines were collaboratively developed so rapidly; or the rise of consortia for exchanging pharmaceutical data for the purposes of accelerating drug development; it seems that data exchange is a hot topic and a potential game changer within our industry.

This week, I heard an impromptu address from Instem’s own CEO, Phil Reason, on this topic. Now I wouldn’t normally mention such things in my blog, as that’s all ‘a little bit too corporate’ but there was a real sense of altruism in the idea that we should be providing the technology to allow pharmaceutical organizations to easily exchange data and research to accelerate the development of new treatments. Our role, even our moral responsibility, is to ensure that that technology doesn’t become a barrier to such things and instead we should be striving to provide such capabilities.

As you can imagine, for someone who has dedicated the last 9 years of their career to developing and rolling out the Standard for the Exchange of Nonclinical Data, the topic really resonated with me, and my mind immediately went to thinking about the role of SEND.

I’m not claiming to have any answers here, but I do have lots of questions for the thought leaders within our industry and how they’d address this type of data sharing.

One thing that I’ve often heard thrown at SEND, is that its value is reduced as it only includes the individual raw data, and not the study conclusions. I’ve heard tales of individuals and organizations using SEND custom domains to list the study’s significant findings, but this is not the same as conclusions, and certainly the SEND custom domain structure wouldn’t seem a good mechanism for handling conclusions. So, would we need to supplement the SEND package in some way? What would that look like?

Which data are the most valuable for such altruistic exchanges? I don’t mean the idea that the Lab Results are more useful than Clinical Signs, I’m wondering about the value of nonclinical safety assessment studies, when compared to early discovery data, or later clinical trials. I mean, are these all equally valuable?

I’m also thinking about the time and effort it takes to convert data to SEND. Does that prohibit data from being exchanged, or at least makes it a little unpalatable? I mean, it’s one thing to go to the time and expense to convert a study to SEND for the purposes of a regulatory submission, but it’s another when it is simply to support someone else’s research and potential break through.

There are many other questions and topics buzzing around my head when thinking about the practicalities of such data exchange, but I’m inspired by the possibilities of finding new treatments and getting them to patients far more rapidly.

Festive greetings and I’ll see you again in the new year.

‘Till next time


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.