Ed Seguine, CEO of Clinical Ink, doesn't think it's realistic to hope for data standards in EMRs (electronic medical records) for clinical trials. He says: “The idea of saying data collection will become standards based is very alluring, but it would require every single company adopt that same standard. That does not happen in the real world. There are very few cases of giant technology standards coming together, as it did with Bluetooth or USB. Even when it does, it is almost always around hardware connectivity. It is almost never about the actual data moving through those connectors. You can always standardize the pipes, but standardizing the flow of what is going through the pipes is much more complicated and difficult.”
Well, ACORD is a great example of an industry data standard created by the community, for the community – so it does happen in the real world.
What is the alternative to standards? “According to Seguine, we have to recognize that there is going to be great diversity in the data streams, and develop systems that make it easier to accommodate that diversity. Then simply merge data with other like data. This will involve judgement calls and decisions being made by people who are closest to the data so as to determine its relevancy, importance, and impact on the integrity of the trial.”
With all respect to Seguine, I don't think this will fly. In brief, when a community agrees an industry data standard, it consults the experts and defines a structure that meets their needs. This expertise is encapsulated in the standard, and it becomes a community asset which enables and regulates the community's knowledge base.
If I read Seguine right, his recommendation is to repeat the consultation process every time someone wants to share data, making no permanent use of the insight acquired. Do we want clinical trials run on the basis of random, isolated judgement calls which, incidentally, by their very nature, can't be programmed? This doesn't sound like a credible solution from either a business or a technology perspective. EMRs