Wednesday, September 2, 2009

CDISC interchange standards in clinical research

Attending a user group for XML-based clinical studies interchange standards (CDSIC) , it gave me pause to think about how casual the presenters were about the effort required and their level of knowledge of the technology. There was no sense of urgency or an objective need -- the kind of urgency that one would expect to arise from competition, and the kind of urgency that would enhance the value of an IT person specializing in the markup technology.

Although there was plenty of talk about what could be done, there was no clear value proposition behind the discussion. Ostensibly, the goal is to satisfy FDA submission requirements and lower the costs of transferring data between Pharmas, CROs, and third parties. There is no good editing interface for the collected data, no way to ease the collection of the metadata comprising the taxonomic portions, and the stylesheet outputs are usable but they look like crap. But there seems no channel for someone like me to get paid to work these issues.

One presenter remarked that it took him two years to reach a basic level of understanding of the use of markup, and he still wasn't quite confident in his abilities. How much was really due to the learning curve of the CDISC standard and how much due to the XML technologies, was unclear, but he also mentioned that XSLT was a major stumbling block, being "unlike any other programming languages".

I've seen this pattern many times before, in which Subject Matter Experts will simply take their time with something that could be accomplished much more rapidly with the collaboration of a technology specialist. The reasoning for having an SME work on the content is obvious, since they are trained in field protocols and the vocabulary of the domain. Yet bringing in one specialist, someone who through training or experience is well versed in the technology side of the equation, could have reduced the lag time by many months. From what I could tell, what has been accomplished technologically (excluding the standards production process itself) could have been done for well under six man months of effort, and without a lot of the proprietary SAS and Java infrastructure.

How can an industry survive by taking a multi-year cycle to respond to a need? I suppose they've got cash to burn.
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