Churchill, the FDA and a Fall
“When I feel like exercising I just lie down until the feeling goes away.” According to the web this quote is from Robert M. Hutchins (1899 –1977) and according to Wikipedia, he was an educational philosopher, dean of Yale Law School, and president and chancellor of the University of Chicago.
The quote was used by Bernard de Bono from the European Bioinformatics Institute, during a question and answer session at the CDISC EuroInterchange that took place in Stockholm last week.
Bernard was talking in the context of creating a new term, a new piece of terminology, a new definition. His plea was don’t do it and hence the quote, go and lie down until the feeling passes. His argument was that, if you do create the new term you are a) saying that this is some new knowledge because no one has defined it before and b) you are creating a maintenance problem.
I am going to leave the first point; I shall leave that for another day. What I want to focus on is the notion of the creation of the maintenance issue. Since the New Year, it has become apparent to me that CDISC has, over the last year or two, hit a new issue. I have discussed the issue with a few folks over the past two months that the standards are now mainstream; as Chuck Cooper from CDER stated at the interchange, 40% of electronic submissions now use SDTM. This, however, means that the standards now need to be maintained. Exhibit one, Amendment 1 to SDTM, Exhibit two the CDER guide on standards. And this is where we hit the big problem. Volunteers and maintenance don’t mix too well.
Another challenge for CDISC is the simple amount of work it is attempting to undertake. This was witnessed by the Gantt chart presented by Wayne Kubick – the new CDISC CTO – that lists 23 major areas of work. In fact the list is probably longer as some of the items contain multiple projects and the list includes only 10 of the 55 therapeutic areas that has been mentioned as being tackled over the coming five years.
I discussed this with a few people at the interchange. The therapeutic area development is a major challenge – more on this in a future posts – but the one issue that came out of the conversations is that are we simply setting ourselves up for a fall. By trying to do too much are we simply bound to fail? And by failing do we damage the good work achieved to date?
There are no easy answers. Is it that CDISC now needs a new business model? Is it time that we have to accept that CDISC needs more resources? Do we have to give up on the idea of volunteer led standards development?
In a decade or so CDISC and the industry have come a long way. 40% standardised electronic submissions is no mean feat. As I noted above, the session within which Bernard made his quote was a panel, question and answer session. I always feel for the panel in these circumstances. I have been there, you can never win. The questions are always of the negative nature. Why have you not done that? When are you doing this? Why did you do that? We focus on the negative. This post is focusing on the negative in that it is looking at the challenge ahead. However, we also need to be realistic.
I believe that Bernard attributed the exercise quote to Winston Churchill. If I have got this wrong then apologies to Bernard but when I looked on the wonderful web it seemed to be from Robert Hutchins. But if I may borrow and plagiarise another Churchill quote: Never in the field of standards development has so much been owed by an industry to so few volunteers. CDISC has achieved so much. Let us not waste it by trying to do too much in the future without the required resource.
And one final note. The views expressed within this post are mine and do not represent the views of any organisation I volunteer for or client that Assero is employed by.