CDISC Blog

Reflecting on the recent European CDISC Interchange, the phrase that reverberates in my mind is “Standards Everywhere”.  This is a credit to Dr. Paul Avillach, who asked to use my camera on Friday evening as half a dozen of us (who stayed through the bitter end to teach or participate in the CDISC Healthcare Link Course and the CDISC-HL7 Tutorial) were heading across Hyde Park in search of Pub food.  At that time, we were gazing in awe at the massive golden statue of Prince Albert when Paul (from Bordeaux, France) spotted Riyi Hsing-Tzu Wu (from Taiwan) holding her black conference bag with the CDISC logo. 

We had been discussing the fact that CDISC standards are the infrastructure that really make it possible to improve global clinical research and thus healthcare, but it is difficult to communicate that.  We were looking for taglines (like “we don’t make X, we make it better” and “Y Inside”).    So, here is the image of “Standards Everywhere”, many thanks to Paul and Riyi.

Okay –back to Friday’s Pub food outing….Bron and Julie and I will confess that, after a very fulfilling and enjoyable week at the Interchange, food and fresh air were on our minds – and not more ‘techie talk’.  Paul, Riyi and Mark Arratoon (who helped teach the Healthcare Link course) were very accommodating, providing  a wealth of conversation that revolved around many interesting topics including photography, movies, France and so forth.   It turns out that Paul is not only an MD working on his PhD (using EHRs for research, including CDISC), but also an accomplished photographer.  Riyi is working on her masters degree and gave an excellent presentation at the Interchange on using EHRs for research (yes, involving CDISC). So, once we were sated with the sights of Hyde Park and some excellent fish and chips and smashed (‘mushy’ peas in the UK) peas (and ale of course), we could finally look back at the complete week.

The Interchange started with CDISC Educational Courses and the Annual Board meeting (which was held in two locations concurrently after the volcanic ash took a toll on half of our Board being able to get to London).  We then worked into the Interchange itself (organized so effectively by the E3C), an evening at Madame Tussaud’s wax museum (you can see all the wonderful 'Paparazzi' photos here), exhibitor booths,

and breakout groups where we received focused, specific input on CDISC standards.  Finally, we finished with the Friday courses- Healthcare Liink, ADaM, Legacy Data Conversion and the CDISC-HL7 Tutorial taught by CDISC and HL7 representatives. Those who did not stay through Friday missed out on more than pub food! 

So, why was the Friday evening outing so meaningful in the context of the entire week?   For me, it is because I used to do clinical research (working with the Pima Indians at an NIH facility in Arizona, after which I gathered clinical research data on populations in Japan); I then taught Project Management, supervised Project Managers and Medical Writing and QC and explored global Clinical Research processes and how we can make them more efficient.  The ultimate goal is to shorten the time to transfer research findings into practice for the benefit of patients worldwide and to improve patient care.  One key component is for us to adopt global standards for clinical research, ensuring that they are in sync with healthcare standards.  It is important that everyone involved in clinical research understand this, not only data managers and statisticians – who get it right away!  

Of particular note at this Interchange, there was an increase in the number of academics who attended (like Paul and Riyi) and there were some investigators, EHR vendors, project managers and medical writers….and 21 countries were represented.   And, it appears that more folks from the ‘front end’ of the process comprehend the value of standards and realize that standards will improve research without inhibiting creativity.  Mark Arratoon (GE Healthcare and Healthcare Link instructor) demonstrated how the CDISC Protocol Representation Model/Study Design can be used to pre-program EHRs to identify and schedule study subjects and Jozef Aerts showed how he used the Study Design Model with the caBIG Study Calendar….and all of this is feasible while adhering to 21CFR Part 11 and GCPs.  EHRs are coming – and why not take advantage of this eSource opportunity to improve efficiency and quality by avoiding transcription. The new Interoperability Specification (which many EHR vendors support) can provide a core set of research data from an EHR in CDASH format (ready to flow into SDTM).   Talk about standards-inspired innovation…and all of this was at the CDISC European Interchange.

Make your plans to come to the next CDISC Interchanges in Japan (20-23 July), China (13 – 17 September), and the US in Baltimore (30 October – 5 November)!   And, if you are a data manager or a statistician, please try to bring along one of your ‘front end’ folks (clinical project manager, investigator, monitor…) to see how standards can save time and resources (without inhibiting creativity) IF they are implemented at the beginning of the research process!

Rebecca Kush

CDISC President and CEO