It is always good to attend a CDISC Euro Interchange to see old friends and enjoy, “Standards in Style”. The event in Brussels had the usual ingredients, a good hotel, an evening event at the Comic Museum and a set of good speakers. However, I do have to admit that I am completely biased in that I am a member of the European CDISC Coordinating Committee (E3C) that organised the event!
A few themes emerged that caught my attention. The first was the topic of standards governance and a contrast between two presentations, the first by Susanne Pangritz of Bayer on “The Implementation of Standards Focusing on Bayer” and that of Jonathan Chainey of Roche on “Integration of Clinical Trial Data Standards at Roche”. I was particularly interested in the difference in the approach to governance taken by Bayer and Roche with Bayer placing the group within data management, while Roche have made the governance organisation a cross-functional group. Both standards teams work with all parts of the business but it was the difference in reporting structure that struck me. I did not get chance to question Susanne and Jonathan but I did wonder how the culture of the different organisations and the respective management organisations helps or hinders the governance process.
The second was a plenary presentation by Dr. Rebecca Kush and her statement that the standards must remain free and open. I have long believed, as do many of the volunteers who give their time to CDISC, that everything that CDISC publishes should be free, open and available to all. Preserving open access must be maintained in order to ensure that everyone in the industry can implement such standards. In addition, intellectual property must be handled in such a way as to preserve this free and open access. It is good to see these statements given the financial pressures that Standards Development Organisations (SDO) face, as well as fact that a significant portion of the therapeutic area standards development is now undertaken by multiple organisations which brings questions about who actually owns what. As long as everything remains open and free, does it matter?
The final topic that caught my eye were two presentations by Kerstin Forsberg from AstraZeneca and Frederik Malfait of IMOS Consulting presenting on behalf of Roche – note that there is no Roche favouritism going on here, Frederick and Jonathan presented a two-parter in the same session – on the topic of ontologies. Roche has been looking at using the “semantic web” – I use this term very loosely – to build a metadata repository for the standards work within their organization. Kerstin’s presentation – she has kindly made it available on slideshare.net – entitled “Linked Data, an Opportunity to Improve the Research Utility of Clinical Datasets” looked at the semantic web, triples, Resource Description Framework (RDF) and many other topics in a very interesting presentation urging us to get involved in this “new” area. There is a lot of work out there, the EU Innovative Medicines Initiative (IMI) has a number of ontological projects and interest in this area can only grow. The big challenge will be in explaining it to the community at large.