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By Mark D. Uehling

April 15, 2004 | Standards are like collard greens. There’s no debate over their nutritional value. But what company has ever grown fat embracing them?

When it comes to commercial clinical data management systems (CDMS), it’s not clear if anyone cooks with standards. Two prominent vendors, Phase Forward and Oracle, have supported the Clinical Data Interchange Standards Consortium (CDISC). But neither company can import or export data in full compliance with the CDISC operational data model. Their timetables for doing so are fuzzy or nonexistent.

So it’s auspicious that two smaller, less bureaucratic upstarts are adopting CDISC with gusto. In February, DataLabs, a 30-employee Irvine, Calif., company, announced a new version of its DataLabsXC suite, software for collecting and managing clinical trial data. It strictly adheres to the CDISC standards. “DataLabsXC was built from the ground up with CDISC in mind,” says James Langford, DataLabs president and CEO.

In a rare departure from her stated policy of neutrality to all clinical software vendors, Rebecca Kush, president of CDISC, let herself be quoted praising DataLabs in a press release. “DataLabs is one of the companies that’s stepping up and being on the forefront of CDISC’s operational data models,” she later told Bio•IT World.

Friends in High Places
To his credit, Langford has won significant developmental assistance and public praise from two Fortune 500 allies: Microsoft and Merck. DataLab’s envious competitors point out that Merck has entrusted it with only Phase IV trials, which are not as complex or tightly regulated as studies in the middle stages of drug development.

In Glasgow, Scotland, meanwhile, another tiny company, Formedix, has embraced standards since its inception in the late 1990s. “We’re growing very rapidly,” says CEO Mark Wheeldon. “Our company is completely focused on CDISC and HL7. Inside our database, we use the CDISC models,” not proprietary ways to organize clinical data.

Wheeldon says there is a brisk business in taking clinical data into and out of proprietary CDMS databases -- and converting it into CDISC-compliant formats in the process. With Formedix software or consulting services, it’s hardly novel that a drug company can set up a clinical trial on paper or in the electronic mode.

What is notable, however, is that at the end of the process clinical data can be easily exported into a database that any commercial partner or a government regulator can analyze and view without proprietary tools. Having prefabricated libraries of icons and drag-and-drop modules to describe and structure the clinical data, Wheeldon says, significantly shortens the time needed to design and set up trials. “The CDISC model does work,” he says. “It saves a lot of money and time.”

A Scottish Rebel
Wheeldon adds that more than a few sponsors of trials have given up on proprietary CDMS vendors embracing CDISC anytime soon. Instead, he says, they are turning to Formedix and other firms to help them convert data in accordance with the standard. “We’re finding more of our business is introducing standards to the enterprise as a whole, rather than just traditional electronic data capture (EDC) studies,” he says.

Interestingly, Wheeldon doesn’t think his company or CDISC pose any threat to Oracle or Phase Forward. Their large installed bases of customers are unlikely to abandon proprietary clinical data formats or applications, he notes.

But he does think change is coming. “CDISC offers a vendor-independent solution for EDC,” he says. “You can choose your best-in-breed EDC solution, then you can do whatever you want with those data. You don’t really care if it’s from Formedix, from Phase Forward, or from Oracle Clinical -- as long as the data come in a standard format. That’s quite appealing to large and mid-sized biopharma companies. You can have Europe running one EDC solution and the States running another.”

Standards Maven
CDISC’s Kush, meanwhile, may have the toughest job serving the pharmaceutical industry that is not in the pharmaceutical industry. She gracefully moves between the worlds of vendors, industry, government, and fellow standards-making bodies such as HL7.

Beneath Kush’s unflappable demeanor, there lurks a politician with Churchillian skills of persuasion. She has, after all, convinced some of the largest, most inflexible corporations and government agencies in the world to get behind clinical standards. Says Ken Getz, the former chief strategy officer of CenterWatch: “I am frankly amazed that CDISC has come as far as it has. It’s a monumental achievement. Roughly one out of every four submissions to the FDA has the CDISC submissions standards.”

For all her gentility, Kush does sound frustrated that sponsors of clinical trials have not used their muscle to force any clinical software vendors to accelerate CDISC adoption. But she speaks glowingly of contract research organizations (CROs), which, she says, have shown the greatest enthusiasm. “The CROs are totally on board,” she says. “They’re implementing this.” She’s also heartened by SAS’s recent release of an update of its dominant statistical application, which has new CDISC-specific functionality.

 For now, Kush is eagerly awaiting the final touches on the CDISC standards -- and a related campaign to make them congruent with HL7. Once those are in place, possibly by the summer, the FDA has promised to weigh in with its own written but unofficial endorsement of CDISC’s work. “I would say the standards adoption is moving faster than the EDC adoption in certain ways,” Kush says. “Once the FDA gets this guidance out, it will blossom more.”


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