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.

4 comments on “Churchill, the FDA and a Fall

  1. For companies committed to standards, it is fair to say that two standards are too many! But that is what we face all the time … existing company standards and emerging industry standards. We know industry standards are the way to go, but we need the transition period to be short. We’ve been in transition for years, yet we seem hardly to have started.

    Over a number of years, CDISC has created a number of SDTM domains and terminology for these domains. And there is a 300 page implementation guide for around 30 of these domains. But there are several problems associated with this work:

    The rate of content creation is too slow, with development time measured in years rather than weeks or months. So, for example, GSK has more than 60 core standards, 400+ therapeutic standards, and 250 validated rating scale standards whereas CDISC covers maybe a fifth of this. Every time a new SDTM domain is created, we have to consider whether to change our standard. At the current rate of creation we’ll be doing this for many years.

    The mechanism for creating terminology is too slow: there are still under 100 CDISC codelists in EVS whereas GSK has approximately 4,000. And the mechanism for creation is too fragmented. For example, the lab test codelist was first released with under 100 codes, the second release had around 400 and the latest release has around 840. But the GSK codelist currently has 1380 and these are written into contracts with central labs. When should we switch from an existing GSK codelist to a new CDISC codelist?

    The SDTM domains are not underpinned by a sound information model. This results in the need for lengthy documentation, the lack of consistency between implementations of a given SDTM domain and the continuing burden of mapping operational objects to SDTM. CDISC recognise this and, in time, CDISC SHARE (based on a solid information model) will provide the underpinnings for SDTM.

    Continuing with the current approach to content creation will not deliver in the sort of timescales that are needed. Dave asks these questions:
    • 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?

    To my mind, there are three key changes that need to be made:
    • Get paid project management/team facilitator resource and logistical support on board, so that team members can focus exclusively on the content rather than having to schedule and run meetings, find volunteers, “train” people, write documentation, respond to review comments etc.
    • Ask volunteers to simply focus on the content – those that are most valuable to CDISC tend to be those most valuable to the company they work for and their time is a scarce resource. We need to find a way to use their time more effectively. Short periods (e.g. one week) of activity would be much more effective than spreading this time commitment across several months.
    • Change the process for content creation. Focus should be on creating SHARE based content rather than SDTM based content (creation of SDTM domains from SHARE content should be largely automated). Here is a much leaner process:
    o Companies divide up the work of identifying research concepts of interest. Each area would probably require 3 or 4 people (2-3 clinical people plus one facilitator who understands the deliverable) the equivalent of a week’s effort to do this. Probably a lot of the work would be in documenting rough definitions of the research concepts.
    o Other companies review these packets and add to them. Similar groups of 3-4 individuals spend 1-3 days effort on this.
    o For each area, a cross-company group “polishes” the set of research concepts, agreeing definitions, identifying attributes of interest (from a checklist), identifying where terminology would be needed, and specifying terminology (if easy). Group should not be too big, perhaps half a dozen, including a facilitator. Administrative assistance (for documenting all this) would probably be needed. Amount of effort would depend on the number of research concepts defined. Perhaps 1-2 weeks (if it could all be done in one go), more if it’s chopped up.
    o Some kind of public review.
    o Incorporation of public review comments. Historically, this has been a very effort-intensive administrative task but there are ways in which this can be done in a more cost effective manner e.g. via use of a smart wiki based approach. And with simpler deliverables the number of comments should be less.
    o Separate development of terminology needed (variable resource needs)

    Of course, this would require some funding to be made available, but the sums required are not huge.

    What do others think?

  2. Dr. Rich Mansky of Abbott spoke on behalf of Dr. Dave Jordan, about TransCelerate BioPharma. He stated that TransCelerate is partnering with CDISC and C-Path to help develop therapeutic area data standards more quickly, as one of the five TransCelerate projects. A new process is being designed with CDISC to speed these standards development projects, and there will be a pilot beginning in November. The first two areas of focus for the new TransCelerate-CDISC-C-Path process will be Asthma and Diabetes. (Please see additional information on TransCelerate in the press release: ).

  3. Bear in mind this Blog was written over a year ago before much of the current information had been released. There are still some questions to address and with so many new standards releases forthcoming, it is hard for many companies to implement the changes. Stability, is what most organisations need at this time.

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