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Data Standards: Are We at the Tipping Point?

By Wayne R. Kubick

Sept. 18, 2006 | The term “tipping point,” made popular by Malcolm Gladwell’s 2000 bestseller of the same name, has become such a part of the popular business lexicon that it was recently used by Wired magazine as the quintessential meme — that is, a unit of cultural transmission or imitation. According to the book, the tipping point is that critical moment when an idea, trend, or social behavior crosses a threshold, tips, and spreads like wildfire — much like an epidemic. The book points out numerous examples of such tipping point moments and notes how those who seize that moment can sometimes ride it toward extraordinary benefit — as Gladwell has himself with his subsequent success.

A decade ago, the prospect of defining standards for representing clinical data was deemed impossible by many, yet a large number of standards-related activities are rapidly converging. So, are we nearing a tipping point? Let’s look at the evidence.

Standards Growing in Importance
The Clinical Data Interchange Standards Consortium (CDISC) originated as a small, volunteer, grass-roots operation in 1997 and has since evolved into a thriving, well-funded nonprofit organization working closely with a number of industry and government groups to promote interoperability among global research organizations. CDISC enrolled its first corporate sponsor in 2000 and now includes more than 170 sponsors and members.

The FDA, which endorsed the use of the CDISC study data tabulation model (SDTM) standard for study data tabulation submissions in July 2004, reports that the number of CDISC SDTM submissions is rapidly increasing — with more and more sponsors expecting to include SDTM data for an upcoming submission. Seven such submissions have been received by the FDA as of June 2006, and one FDA speaker at the recent Drug Information Association conference (which featured more than 30 presentations on data standards) mentioned that pre-submission meetings involving use of the SDTM are being held “almost weekly.” The FDA has stepped up internal training and seminars in the use of CDISC standards. And according to the April 24, 2006, Federal Register, a Notice of Public Rule Change to require submission of data in standard format is close to being posted for public comment. More than 6,400 copies of the “SDTM Implementation Guide for Clinical Trials” have been downloaded from the CDISC Web site to date.

Attendance for CDISC training at various standards conference functions, training classes, and CDISC informational webinars is growing fast. More than 200 individuals are participating in CDISC projects and teams currently, and hundreds more provide comments on posted standards and participate in CDISC events.

Elsewhere in the U.S. Government, CDISC standards are being implemented at the National Cancer Institute (NCI), which is providing its Enterprise Vocabulary Services (EVS) to manage controlled terminology that will be used with CDISC standards. CDISC is also a major participant in U.S. Government electronic health record  initiatives, participating in CCHIT, HITSP, and other forums. CDISC is collaborating with NCI and the Health Level Seven (HL7) ANSI-accredited standards organization to develop the Bioresearch Information Grid (BRIDG) model, which will serve as the underlying model for implementing interoperability between clinical research and healthcare. CDISC and HL7 have also collaborated on many other standards initiatives, including the CDISC LAB standard and structured protocol. CDISC is also playing a major role in the World Health Organization’s guidelines for clinical trial registries.

More clinical data management and clinical IT vendors are announcing current or planned support for CDISC standards in their products — and more and more requests for proposals from sponsors specify support for CDISC standards as a requirement — whether for individual clinical study projects or major clinical IT procurements. Several sponsors — such as FDA and NCI — have begun to implement clinical data repositories based on the CDISC SDTM.

Clearly, momentum toward standards is building, and quite possibly about to tip.

What Does It All Mean?
When faced with a potential tipping-point scenario, a stakeholder must first assess the urgency of opting in and then decide how to react. For example, a videophile will likely agree it’s too early to standardize on Blu-ray or HD-DVDs, but do you really want to keep investing in VHS tapes at this point? So those involved with clinical data could begin by answering the following questions:

•           Do you have a strategy for using CDISC standards in your next FDA data submission?
•           Do you understand which of the CDISC standards to apply where? (SDTM, SEND, AdaM, and define.xml for submissions; ODM and LAB for operational data interchange)
•           Are you working with vendors who can speak CDISC with each other?
•           Are you identifying ways you can exploit current and emerging standards to build efficiencies in drug development, be more proactive regarding patient safety, and expand your ability to utilize clinical data?
•           Are you contributing to this unfolding tapestry as a participant in standards development, a CDISC sponsor, or an implementer?

Gladwell’s latest book, Blink, observes that some of the best decisions are often made in the blink of an eye. So, quick — are you implementing CDISC and other relevant data standards yet? If not, what else are you waiting for?

Wayne R. Kubick is senior vice president with Phase Forward’s Lincoln Technologies subsidiary and CDISC technical director.  E-mail:


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