CDISC Blog

Rebecca Kush, 'What is a Standard?'

November 4, 2009 at 4:12 AM by cdisc

I have been informed many times that the word ‘standard” connotes such ideas as rigidity, stifling creativity, inhibiting innovation. There are indeed many different types of standards (from a sort of flag, to a type of rather mundane beef to a standard operating procedure). What we are talking about is ‘technical standards’, defined on Wikipedia as an established norm or requirement. It is usually a formal document that establishes uniform engineering or technical criteria, methods, processes and practices. Types of technical standards include a standard specification (an explicit set of requirements for an item, material, component, system or service); a standard test method; a standard practice (SOP); a standard guide; a standard definition (formally established terminology); standard units etc

Technical standards are necessary to encourage innovation in the right areas. Where would we be without the W3C and electronic data interchange standards in the banking industry? Without standards such as our trusty USB drives on which we carry our presentations to meetings?

We in CDISC need to continue to communicate the value of standards, particularly when used at the ‘front end’ of the clinical research process—by this, I mean at least the use of CDASH for data collection (and hopefully in the near future, for protocol development).   I recently had someone tell me that they still don’t see the monetary value of using CDISC. I immediately asked, “Are you using CDASH?” Note that, if you don’t use standards to collect the data in the first place, mapping at the back end is costly in terms of resources and time and the collected data never really ‘fit’ the way they should into the target standard format. More about this in a future blog spot… in the meantime, please read the CDISC Book, Introducing the CDISC Standards: New Efficiencies for Medical Reseach.

So, back to “what is a standard”? The following was published by John Halamka on the Federal Advisory Committee Blog this week:

A standard (per the definition of the Healthcare Information Technology Standards Panel) specifies a well-defined approach that supports a business process and: (1) has been agreed upon by a group of experts; (2) has been publicly vetted; (3) provides rules,  guidelines, or characteristics; (4) helps to ensure that materials, products, processes, and services are fit for their intended purpose;  (5) is available in an accessible format; and (6) is subject to an ongoing review and revision process.

I would argue that a ‘proprietary standard’ is really not a standard…in fact, this term sounds like an oxymoron to me! When one-off standards are used, interoperability cannot be achieved and data sharing and integration are tedious, costly and thus severely compromised.  

So, when talking about technical standards, I would hope we mean open, global, industry-wide standards. This statement then brings to mind what ‘industry’? In the case of CDISC, if we want our standards to be valuable for CDISC stakeholders, we need to consider that the data we are using and for which we need standards is a subset of healthcare data. In the global world, the goal of biomedical research is ultimately to improve the lives of patients. Developing a standard only for biopharmaceutical companies would be doing them a disservice; there are overlaps and intersections between clinical research, academic research, healthcare and now genomics and even discovery and the boundaries are blurring with the electronic exchange of vast amounts of information that should be assimilated into knowledge. Hence, the scope of CDISC is to develop standards for biomedical research and the overlapping arenas of healthcare.  Developing standards in a silo is no longer an option.

Back to the HHS genomics workshop, a few key messages resonated.  There is much good research going on in this area and, without agreed and adopted standards, we will not be able to reap the knowledge that all of this data holds. Standards are being developed, but are just now being understood and employed – we need to get the word out to have more participation in the development, review and implementation of these standards. We need to communicate the value of standards, in general, so that researchers understand that they could actually enhance innovation!

 
The same goes for all of the CDISC standards. There is information on the CDISC website and in our book about the Benefits of Standards – open, global, free industry-wide standards.