I had the pleasure this year of presiding over the team awards. The awards are given out, as you could guess, to CDISC team members who, in the opinion of the team lead, have performed above and beyond the call of duty. The team awards go to those people without whom the standards just don’t get published the individual who spends endless hours in the evening going over the 600 comments you have just received on the latest public review and organises them ready for the team as whole to process. These are the people who make the standards possible.
One feature of the CDISC work is that, as time goes by, a team lead will step down. They move job, just feel the time is right for a change but, whatever the reason, CDISC wants to recognize their contribution. This past year John Troxell had stepped down as ADaM team lead. About three years ago Susan Kenny “retired” as ADaM team lead and I remember presenting an award to her for her great service to the cause and remember trying to think of a single word that, to me, represented everything that Susan had contributed to CDISC. I think the word I settled on was gracious but one of the words I did remember thinking about was serene in that Susan is always calm. As I said jokingly in the presentation to John, serene is not a word I would associate with John. John has immense passion for his work, a questioning attitude, unafraid to speak his mind and will strongly defend his position. However, John is also open to new ideas, new thoughts and it is this combination of personal attributes that has allowed him to guide the ADaM team over the last few years and permit the team to deliver the first ADaM Implementation Guide and establish the standard firmly in the mind-set of the FDA. It was with immense pleasure that I was able to present the award to John at the Wednesday lunch session in front of the CDISC Interchange audience and publically recognize his contribution.
The presentations highlight the important support that CDISC enjoys from individuals and organizations in the development of the standards. Standards do not develop themselves, it takes considerable effort and that effort is put in by people, people that are committed to the cause. There are many flavours of volunteer, some of the volunteers donate their time but are unable to travel because of the costs, others are supported by an organization, an organization that funds their time and their costs to attend meetings. Whatever the model, however much they donate, these volunteers are the lifeblood of the standards, these are the people that make it happen and I would like to say huge thank you to all the people and the organizations that support CDISC.
I was asked at the end of the interchange what was the single take away message. I always love questions like this, I have to try and look intelligent and feel some pressure in that I have to come up with something deep and insightful but it is difficult. There are so many moving parts, unexpected actions by individuals, events that we cannot predict. But I took my crystal ball out and I answered with an analogy. I am crossing the street and a glance up to see a truck coming towards me. A year ago that truck was a long way off, but now it is a great deal closer and the driver (in some kind of insane horror movie fashion) has just put his foot on the accelerator (the gas for my American friends). I need to get across the road quickly; I need to prepare for standards. We saw from the interchange that at the FDA, CDER and CBER are moving faster with renewed energy. There is a greater spirit of cooperation across the agency and electronic submissions are flowing in. Those submissions are not just ones that contain SDTM tabulations – the FDA revealed that there have been around 150 such submissions – but there is now an increasing number that arrive with ADaM analysis datasets.
So this is why I believe that those who read this, who are engaged in research and who want a better process, that standards are something that no organization can ignore whether or not they submit to the FDA. They are now mainstream. An increasing number of organizations now see them as an integral part of their process and those organizations are your partners. And there is no better way to understand all of the issues than by becoming involved in the work that CDISC performs on a day-to-day basis. As an individual volunteer helping CDISC you will gain access to what is happening, you can influence the direction of the work and help us produce better the improved versions of the standards faster. As an organization, this has benefits. You help shape the industry and gain an earlier insight into those events that will influence that shape. There is no better example than the FDA panel discussion within the CDISC Advisory Board (CAB) meeting. For a couple of hours representatives for the agency discussed and answered questions posed by members of the CAB on a range of topics related to policy and standards. It was probably the best CAB meeting I have attended for a long time.
As I walked around the lunch room locating the various team leads, I felt proud of what CDISC has achieved and proud to be associated in my own small way with the volunteers who make it happen. To all of you who have contributed in the past, I would like to say thank you. To the organizations that fund your involvement, the time, the hotel bills, the flights, I say thank you. To those not involved yet, to the organizations that are not members I say get involved. It will be to your benefit.
Dave Iberson-Hurst
CDISC Technical Architect
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