At the beginning of October last year, the A3 team at S-cubed launched the Community MDR. Now, only 4 months later, there are over 100 users in the system, from 55 different organisations, across 27 countries. It’s incredible progress for an idea that was born whilst watching a stage of the Tour de France in 2015.
A Community Story by AJ de Montjoie
Dave Iberson-Hurst has been around CDISC, CDISC standards and CDISC Terminology for nearly two decades. A long stage in the Tour de France, with an equally long climb up the Col du Glandon, was a defining moment. Never afraid to challenge the status quo, Dave started building the Glandon MDR, which has become the A3 Suite, to automate and improve the way we work with clinical metadata It has been an interesting journey, from ODM, to CDISC SHARE, to the new CDISC Library API. However, as Dave demonstrated at the recent CDISC Technicon, we are quite some distance from a fully automated machine-readable end to end solution for our most valuable asset, our data.
Accepting a Standard
Standards are common across regulated industries, but the pharmaceutical industry took some time to embrace the idea of collecting, analysing and submitting data in a standardized way. In fact, if we’re honest, only with the regulatory bodies across the globe insisting that data was submitted in SDTM (and ADaM in Japan) did the CDISC standards become accepted by industry. In the meantime, sponsor organisations tried to build procedures around a disparate set of solutions that solved the problem of getting their data through the trial process. Most of it was (and is still) manual, slow and costly. But that is history. Where are we now?
Missing BUNS?
One of our BUNS is missing!
There are now 62 packages of CDISC terminology for use with the CDISC standards. 62! Can you quickly and easily look at a spreadsheet with all that CDISC terminology in it and identify all the changes? Dave and the A3 team realized that for most people working in pharma and related companies, CDISC terminology has become so vast that it was very easy to lose control. In fact, Johannes Ulander wrote several PHUSE and CDISC papers about, ‘The Great BUN Mystery’ nothing to do with cakes or pastries unfortunately. However, the Blood Urea Nitrogen CDISC Submission value had mysteriously vanished from the STDM LBTEST. Where had it gone? Had it been replaced? Had it vanished forever? As Johannes reveals, the submission value had changed to UREAN. You would have to spend a very long time looking through endless spreadsheets to find. Perhaps it would be uncovered when you reviewed your data and realised you now had two submission values in your data for the same item. Of course, this is one example of the multiple, changes, additions and deletions that have taken place since 2007.
Supporting the Standards Community
So, how could S-cubed and the A3 MDR help? How could we assist people with their everyday terminology challenges? With an MDR built using Biomedical Concepts and graph data, all the information was sitting there: the entire history of CDISC Terminology in a machine-readable form, tagged for each standard and easy to search at the click of a button. So, it wouldn’t matter if you had used version 31 of the CDISC CT or the latest, you’d be able to compare the differences and see if you had any missing ‘BUNS’. And so, the Community MDR was launched. It has been welcomed by many and is used on a daily basis by our growing users.
“I just wanted to say that I used the Community A3 MDR today to figure out when the MOTEST/TESTCD codelists were deprecated. It took me all of 7 seconds and about 3 of those seconds were spent figuring out which buttons to push. This is massively better than the 10s of minutes it would have taken me otherwise. I just wanted to say thank you for a great/useful tool!”
Erin E Muhlbradt, PhD, Clinical/Biomedical Information Specialist, Enterprise Vocabulary Services, National Cancer Institute
We can’t thank Erin enough for her support and as an early adopter of the system, she has been a great advocate and understands the needs of the user community.
Upgrade to Sponsor Terminology
But our work doesn’t stop with the free version of the system. Sponsor Terminology is the next pain point for most companies. Our system and its interface are user friendly and with no installation (it’s all cloud based), our expert team will quickly be able to help you load your sponsor terminology including QA support. Minimizing the impact on the current processes in your organisation, we can then export the newest version out again in any common machine-readable format (incl. Excel). There is extensive knowledge of the CDISC standards at S-cubed and real-world experience of standards implementations across a variety of organisations. Starting with terminology gives an organization experience of using our platform. This allows you to get the foundation in place. Indeed, our team would advise that this would be best practice. Completely throwing out all your current systems to implement something new is often not the best approach, as it’s hugely disruptive, involves teams across different functional areas, and getting the basics right is important. Ultimately our SaaS solution (the A3 Suite) was built and designed to automate data consistency from data collection to submission. So, start small with your terminology and then expand to meet your organisation’s needs.
Finally, you have nothing to lose by using our Community MDR, there are videos available to give you guidance on how to use the system and it might just save you a huge amount of time hunting through spreadsheets. Give it a go and let us know what you think. Of course, if you want to add your own terminology, then get in touch and we will be happy to demo our solution.