This is the News

This year’s North American Interchange rounded off a successful year for CDISC events, with the highest ever attendance figures for a CDISC conference. For the first time at a US event, CDISC stepped out of Washington to Baltimore and held their inaugural social event at the National Aquarium (more of this later).

The conference was privileged to have several keynote speeches on the first day:  Dr. Frank Rockhold, GSK and Dr. Christopher Chute, Mayo Clinic College of Medicine. Key highlights from those opening speeches can be read on the CDISC Blog. The main thrust of Frank Rockhold’s presentation was to ensure that a global audience understood the imperative to implement the CDISC standards and how that message is conveyed to those outside of data management. As those of you who have tried to convey this message to senior managers will know, this is not always a simple task. We would recommend that you start by handing them a copy of the CDISC book: Introducing the CDISC Standards: New Efficiencies for Medical Research. Christopher Chute continued the broad theme of interoperability and also reinforced the message of working with healthcare to ensure that there is a close connection with research.  Both the keynotes emphasised a patient centred focus, something that is important to all of us. 

The CDISC Updates session has become an integral part of the Interchange and keeps our community abreast of the latest developments. Dr. Rebecca Kush began with her extensive roundup of the global activities that have taken place across 2009. You can read a summary of her presentation here on the Blog. She was followed by a summary from the CDISC Coordinating Committees in Europe, Japan and China who have all been busy with events and expounding the CDISC message. Concluding with the CDISC Team updates, it’s evident that CDISC is busier than ever working on the standards on behalf of its members.

Of course, our conference would not have been complete without the input from the FDA and this year we were honoured to have the new Principal Deputy Commissioner, Dr. Joshua Sharfstein, join us on the second day of the conference for his first meeting with the CDISC community. He was welcomed by Rebecca Kush and spent some time looking at the Healthcare Link demonstration in the lobby before taking to the podium to address an eager audience.  After an introduction by CDISC Board Chair, Dr. Edward Helton, he began with a lovely anecdote citing that he had been accepting every invitation to speak at conferences, including one to a cake manufacturers’ panel, at which point his assistant asked him politely to stop accepting everything that landed on his desk from Baltimore! He cancelled the cake speech, but he felt that CDISC was an opportunity too important to cancel and for that we are grateful.  

                                                                                                                            
If you have been reading our Blog, then you will be aware of the flurry of activity and discussion at the FDA Panel session.  Clearly, for most of the attendees this was one of the highlights of the event and you can read both Rebecca Kush’s views of the presentations by the panel and Dr. Sharfstein’s speech and Dave Iberson-Hurst’s impressions of that session on our Blog. We would welcome your comments and thoughts about the interesting discussions that took place. Feel free to add them to our blogs.

The sessions and the training revealed the growing implementation of the CDISC standards and greater understanding of the benefits of the standards. CDISC SHARE was presented for the first time at this interchange and interested audiences listened closely to the benefits of an industry wide shared metadata repository for health and research. The increased pressure on CDISC to develop efficacy (therapeutic area) standards will benefit considerably from CDISC SHARE and you can read more about SHARE on the website. The standard specific sessions were as busy as ever with presenters explaining their implementation successes and offering advice to audiences hungry for information. However, there is an ever-present need to encourage implementation of the standards and one of the focuses for this year has been to broaden our communication channels. With this in mind, Tweets were sent directly from the Interchange and Blogs were posted frequently on the website. If you haven’t already done so make sure you follow us on Twitter and subscribe to our RSS feed on the blog.

As usual our exhibitors were a fundamental part of the wonderful atmosphere at the conference, supplying expertise and, new this year, some of the vendors took part in the SDTM validation tools demonstration. These demonstrations are vital to support understanding of the Model and to ensure SDTM is implemented correctly. On Thursday, Landen Bain had the Healthcare Link participants demonstrating how information from EHRs can be successfully utilised for research purposes. The Retrieve Form for Data capture profile is part of the work that Landen has been involved with at IHE and this solution can be used now.

Of course, it goes without saying that the evening social event at the National Aquarium was a memorable experience for everyone. Starting with drinks and food at the Shark tank was wonderful, as everyone was treated to the sight of huge rays and some very impressive sharks swimming beneath them.  Attendees chatted informally as they wandered through the various displays and eventually found themselves at the spectacular jellyfish exhibition, where they were also greeted with some rather delicious cakes and pastries. It was a truly unique event and we thank the Aquarium for our private viewing. I am assured that no-one went missing and there were no particularly fat sharks after everyone had left!

Once again, CDISC would like to thank all those who contributed to the success of this event particularly the CDISC Advisory Board who developed an excellent program, the many speakers who had prepared excellent presentations, the exhibitors and of course all the attendees who bring so much to CDISC, both as volunteers and as part of our collaborative community.  We look forward to you joining us in 2010!

Interchange Europe, Lancaster Hotel, London, United Kingdom
26 – 30 April 2010 (Call for abstracts now open)

Interchange Japan, Tokyo, 27 – 30 July 2010

AJ de Montjoie