I am just preparing the first blog covering my journey in to the semantic web and that should be with you later this week or early next week. However, something that has cropped up a few times in recent weeks is the question of vision. In more definite terms, what should we be doing as a company, in terms of standards and technology development?
There are no simple answers and a short-ish blog post will not provide detailed answers. I thought it might be interesting to write down a collection of high-level thoughts and see if people find them useful to fashion and guide their own thinking.
One goal I keep in my head is based on a presentation I did back in late 2006 to some folks at the FDA, as part of talking about the potential of using the CDISC Operational Data Model (ODM). In particular, I spoke about the “Chain of Custody”. The idea was not only being able to trace forward from the capture of the data through analysis and onwards to submission but also in the opposite direction. I painted a picture of an FDA reviewer being able to view data on screen, click on a data point and instantly see the entire history of that data point, its providence, be it a data point that was captured or some summary statistic or calculation. If it was a captured data point, we would want to see the CRF page, the audit trail of changes and then its flow through the analysis process and the final submission.
Why this scenario? Well I choose it because it encompasses an awful lot of capabilities. It requires electronic data for starters rather than paper, it requires standards at a number of levels such that the data can be understood, stored and transmitted. It requires high-quality data, it requires an audit trail, it requires data in known places that can, as I say, be understood, it requires metadata. It requires many capabilities we are working on, but it places them into context and paints a vision, a vision from the perspective of standards and technology but also from that of the regulator and protecting the public health.
From the pharmaceutical company’s perspective, there is a need for technology and standards to support that “better” process – and we need to define better, quicker, cheaper obviously come to mind but support the mainstream development and submission activities. Companies want to be able to: understand the data, know all about it, know that the data is traceable and be in a position to answer any query about it from a solid position of knowledge, rather than one of semi-ignorance. It might also be good to be able to find the data when we need to! A company also needs to avoid “data decay”. By this I mean that we want to be able to understand the data in five years, 10 years or 15 years in the same way as today, whether or not the people who worked on it are still around or have moved on to pastures new. And a company would want to be able to be able to use the data: manipulate, aggregate, review and re-examine in ways that we may not have envisaged today.
As an aside from a company’s vision, I would say it is unfortunate that we do not have an industry-wide vision. It is, in my opinion, not a technical challenge as such though there are technology challenges. It is more a question of having the will to build that vision as a collaboration of regulators – note the plural there – and industry and others engaged in research. It requires a vision stating what is required rather than what should be built. But that is an aside.
Returning to a company vision, the high-level statements I presented above are the sort of statements that help fashion a vision. One advance I have never yet understood is the deployment of clinical data warehouses without the associated, “sufficient and appropriate” metadata. When I said, “use the data: manipulate, aggregate, review and re-examine in ways that we may not have envisaged today,” I cannot envisage that being possible without well-structured metadata. That then brings you to the role of the CDW, is it a simple repository of data such that the data is not lost, or is it the source of institutional knowledge?
A vision should be short and concise. It should guide you in what you need to do and be there to refer to when you are down in the weeds and forgetting why you are there in the first place. Acting without a vision is rather like trying to build a car without knowing what a car is or why you need it; in the end the resulting “product” won’t do the jobs you need it to do and, more likely, actually hinder you.