Dr. Kush demonstrated the true global nature of CDISC by highlighting the work going on around the world, in Europe, China, Japan, Singapore and Australia. Recently a new CDISC coordinating committee started in Korea, in addition there is great interest in developing a committee in India. The recent CDISC SHARE webinar had registrants from 21 countries and the CDISC database now has representatives from 60 countries. CDISC is a truly global organisation.
CDISC now has a complete suite of standards that cover the entire medical research processs from protocol through to submission and reporting. Dr. Kush spoke of the 'proprietary standards oxymoron' as a proprietary standard in itself is not a global standard and can't be used by anyone else. She spoke of the requests from industry, the CDISC technical teams and the FDA for CDISC to develop more standards, to develop them faster and to focus closely on content. CDISC is listening and is now working to deliver those needs. Dr. Kush also made it clear that in order to get the most value from the CDISC standards; they should be implemented from the start of the process and encouraged everyone to implement, 'stuff that works, now!'
One of Dr. Kush's key points came out through a simple question that she asked of an attentive audience, 'How many of you are patients?' She was quite surprised that not everyone had immediately put their hands into the air! CDISC is ultimately working for the benefit of patients and as Dr. Kush says so eloquently, 'We are all patients.' HITSP recently announced Interoperability Specification #158 which uses HL7 Standards, the IHE RFD profile and CDASH as part of that specification. This is a huge step forward and the CDISC Healthcare Link, led by Landen Bain, has ensured that CDISC is keeping research interests in the Healthcare world closely aligned.
Dr. Kush went on to echo what had been spoken about in the opening session, that collaboration is vital to CDISC’s ongoing work. She emphasised that CDISC does not want to compete with other standards development organisations but that CDISC wants to build harmonized standards with many different organisations. The audience were perhaps surprised by the sheer number of groups that CDISC works with and that CDISC represents its members’ interests with all those collaborative groups. Of course, during hard times companies have cut back on their expenses and sometimes not renewed their membership but without members CDISC cannot develop much needed updates and new standards. Dr. Kush warmly thanked everyone who continued to support CDISC and encouraged those who were not members to talk to Tanyss Mason at the CDISC booth and join today!
Dr. Kush's 2009 Messages:
AJ de Montjoie
