May 9, 2003 | Clinical trial data inhabit a fantasy landscape not unlike J.R.R. Tolkien's Lord of the Rings. Clinical data and ordinary health data are like two bizarre, pointy-eared species that never, ever meet. The two types of information are handled by different paper forms and computer systems. Lab results and other critical information get recorded twice — once for a clinical trial and once for ordinary medical care.

Rebecca Kush

This double entry would have gone on forever, if not for Rebecca Kush. If there is one wizard in medical Middle Earth who can connect clinical trial data and ordinary hospital data, it's her. Polite but firm, she's the president of the nonprofit Clinical Data Interchange Standards Consortium, or CDISC. The key to Kush's success is not how many full-time employees CDISC has (three and a half).

Instead, the crux of CDISC's influence is who its friends and supporters are. Dozens of clinical trial fanatics (volunteering time for CDISC inside software vendors, the FDA, and pharmaceutical and biotech companies) have worked on its data models to get them to a stage where they could soon be harmonized with HL-7, a widely used standard for medical data. That could unite hospital and clinical trial data for the first time.

In basic terms, the CDISC standards can pump all the data from a trial into both XML and SAS formats, finally allowing drug companies and the FDA to compare results on similar drugs on computers, not on paper. It may also save money: Moving trial data around now costs $150 million annually, Kush says.

The hope is that the FDA will issue a formal "guideline" endorsing CDISC's standards by the end of the year. But Kush says the agency is already testing a database filled with CDISC-friendly data. "The FDA has a vision that's very commendable and has been working with us very closely," she says. "This is an excellent example of industry and government collaborating together. It's a huge, high-level effort to standardize healthcare with clinical and genomic data."

Most of CDISC's funding, of course, comes from the pharmaceutical industry; all of the top 20 companies belong to the organization. "The pharmaceutical companies are using it already," Kush says of CDISC. "Schering reported their use of it last week. Johnson & Johnson is using it. Merck is using it."

Once the FDA blesses the technical details of the CDISC standards, Kush says CDISC will publish "conformity guidelines" for software vendors to follow. "We'll probably make sure some independent group does the certification," she says. "There are vendors that want people to believe they're compliant, but they're not. People have to be careful about it."

—Mark D. Uehling

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