It recently came to my attention that the National Institute of Neurological Disorders and Stroke has been conducting a project to define a data elements dictionary that can be used in trials it sponsors. The intent is both to facilitate data collections and storage as well as to promote data sharing. While there are many similarities in the data needed for different therapy areas, there are also many differences in both content and in structure. This makes creating a single data dictionary something of a challenge.
Tackling this challenge would be a tall order in a company, but there everyone (at least in theory) reports into the same organization, and, provided management has the intestinal fortitude to do so, common approaches can be mandated. The NINDS project has an even greater challenge, in that it has a significantly smaller degree of control over the structure of the studies it sponsors and thus must provide carrots rather than sticks (i.e., give investigators incentives to cooperate, rather than force them to do so).
This project is an example of an increasingly popular trend towards sharing data in the academic and government research environments, and to a lesser extent in industry (the latter being driven mostly by the need to create consistently structured data for regulatory submissions). CDISC is the most familiar one to those of us in industry, and it is aimed primarily at regulatory agencies. Outside of industry, I know of HL-7, which is (among other things) a set of messaging standards for defining and exchanging data between healthcare providers. There is also the National Cancer Institute with its caBIG project, which is a set of data dictionaries and processes for standardizing the definition, collection and storage of data from oncology trials sponsored by NCI. There may well be other projects.
It is wonderful to see such awareness of and enthusiasm for standardization. This can only help to increase efficiency, reduce costs, and enhance the safety and efficacy of medical treatments. On the other hand, it is a concern that, although these organizations do have some awareness of each others’ work, they are still working mostly independently. Not only is there some duplication of effort, but they will inevitably make different decisions and produce slightly different results. Anyone involved in such a project understandably has a tremendous sense of ownership and will be committed to his or her own decisions. At some point the various schemas will have to be harmonized, and this will require a great deal of work both to achieve the harmonization and then to apply the results back to the source systems. Because of this, it is critical that the organizations already developing standards be open, transparent and vocal about their work so that any other organizations contemplating initiating a standards project will join an existing one and work toward ensuring their needs are met there. By the same token, it is encumbent upon the existing projects to be open to the needs of others so that the number of projects is limited and eventual integration is not even more daunting.
Photo: Phyllachne colnsoi. Haast Pass, South Island, New Zealand. Flowers approx 3 mm diameter. c. 2006, Kit Howard.
