For a variety of different reasons, at several times this last week, I’ve reiterated my motivations for being a CDISC volunteer. I’ve discussed how I first fell into volunteering almost accidentally, not knowing what I was getting into, and discovering I had a real passion for SEND. I’ve also been talking about the importance of being involved in the process of shaping SEND.

With lockdowns and restrictions easing, I recently got to take my daughter to see Hamilton. Originally booked for 2020, finally it’s back in production. One of the big musical numbers has the hook like “in the room where it happens” referring to being party to important decisions, in the case of the Hamilton play, decisions that shaped the United States.

For me, and my fellow CDISC volunteers, it’s important that we are “in the room where it happens”. It’s one of the things that allows us to speak about SEND with such confidence and authority. It’s no co-incidence that many of the SEND related presentations this year at SOT in San Diego were given by CDISC volunteers. Those who were “in the room where it happens”.

While we are talking about SOT, I was unable to attend myself, but the reports from my on-site team suggested that for many individuals and organizations, the conversation had moved on from “what is SEND?”, “Do I have to have SEND?” and “Is SEND really required?”, to discussions around visualizing SEND and using the standardized data for mining, cross study analysis and generally getting greater value from the data. Indeed, for many organizations, there seems to have been a shift away from converting only the minimum required amount of data, to an appetite to have more and more data in SEND, such is its value.

I started this post saying that I’ve been reiterating my motivations for volunteering, and hearing about the value of SEND speaks to my biggest motivation of all: I believe in SEND. I believe that it ensures that the experimental drugs which are given to vulnerable patients on clinical trials, are safer. I believe that having more studies in SEND leads to better decisions and ultimately that means safer drugs and better treatments. I believe that the more data in SEND ultimately speeds up drug development, and to paraphrase my own organization’s mission statement, it brings new treatments to people, faster.

I hope that idea comes across to even the most casual reader of this blog. Ultimately, SEND, though just one piece in a vast jigsaw, really does improve the drug development process. For that reason, just like I’m hearing from many organizations, I want to see more SEND. I want to see more studies in SEND. I want to see more datatypes in SEND. I love working with the other pioneers who share the desire to see beyond compliance.

So, I love being “in the room where it happens”, I love debating SEND, and I love seeing SEND put to greater use because I believe in the value of SEND.

As usual, if you would like to discuss any of these points, please feel free to drop me a line marc.ellison@instem.com

Till next time,

Marc

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.