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By Mark D. Uehling

June 17, 2004 | Software vendors charge $50,000 or $250,000 for the tools to collect data from one clinical trial. But two tiny upstarts are trying to give that lemonade away.  Chris Maeda of Visitrial and Mike Calder of PhOSCo believe open-source software for clinical trials will be cheaper and more reliable.

Others are not so sure. "That's all we need -- another EDC vendor," jokes consultant Ron Waife, president of Waife & Associates. Still, Waife considers open-source projects to be a serious alternative to in-house systems based on Oracle databases or Microsoft .Net. "Open source as a corporate development platform is a great idea," says Waife.

Waife is most intrigued about open-source clinical trial management systems (CTMS) -- programs that monitor clinical sites, investigator payments, and patient recruitment. As he explains: "The needs of pharmaceutical companies and contract research organizations vary so greatly that companies end up building or heavily customizing CTMS. Open-source tools are less expensive, have lower overhead, and are designed for rapid prototyping."

Pharma's hypothetical affection for open-source projects, Waife predicts, may ultimately turn on the ability to tightly tailor the shape of the final application. That motivation guided Pfizer's marching orders for Oracle Clinical and Merck's for DataLabs.

Embracing Standards
Standards could also play a role. Both PhOSCo and Visitrial are embracing the Clinical Data Interchange Standards Consortium (CDISC) more enthusiastically than large EDC vendors. Visitrial is designed around the CDISC operational data model and will evolve to conform to CDISC standards as they evolve, Maeda vows.

Visitrial is offering academia a free EDC application -- and hoping to license the same code to corporations that seek to customize or integrate it. The unvalidated Visitrial EDC application runs on Macs, PCs, and $250 Linux boxes.

Not surprisingly, Maeda takes a dim view of traditional EDC companies, saying their products and services are inexplicably overpriced. "The differences between the EDC vendors are not in their technology," insists Maeda, an MIT graduate who previously worked at Kana Software and Xerox's PARC research facility. "They are in the organization they build around the technology to try to deliver trial execution services, or to support other organizations running trials. A company like Phase Forward is not really a software company as much as a technology-enabled contract research organization (CRO)."

Alterations Welcome
Maeda believes open source will appeal to customers who always tinker with in-house or commercial applications. "Over time, people who want to customize their EDC applications are going to settle on an open-source foundation," Maeda predicts. "If you're an IT person in a pharma or a CRO, this will let you get to a fully integrated solution for managing trials. It is designed to be embedded and extended."

PhOSCo, meanwhile, has what may be the EDC realm's only blockbuster. After licensing the PhOSCo source code to Novartis for a mere $500,000, Mike Calder, CEO of Guillemot Design, helped the drug giant customize his application. After additional tinkering within Novartis, that company says it has achieved significant efficiencies and mind-boggling savings -- perhaps a quarter of a billion dollars Other pharmaceutical and biotech companies do a few trials with EDC; Novartis boasts that 100 percent of its Phase II and III studies collect data electronically.

Some of Calder's improvements were incorporated into the standard PhOSCo application, which is now licensed for $1,300 per trial. (Others, considered proprietary by Novartis, remain secret.) The English Calder is a former IBMer, and that company delivers the PhOSCo application in Switzerland and Germany. There is a new PhOSCo development center in India as well.

Calder is not sure why other pharma companies have not followed Novartis' lead. "I suspect a lot of it is internal politics and not-invented-here syndrome," says Calder. "I've been selling to this industry and working with them for 10 years. I still don't think three quarters of the industry is serious about EDC. The ones who are serious are the CROs, who are starting to see their business disappear."

A Staff of 3?
Calder says it is possible to implement EDC with a handful of IT staff. "You've got to have one person in the organization who understands Java and the Internet, who is going to be the technical guru. You have got to have one person in your organization who understands the clinical process. And you could probably do with a good project manager." In one German consortium, he says, three such individuals are supporting clinical trials at a dozen universities.

And Calder points out that big EDC companies like Oracle Clinical process errors and discrepancies in batches. This practice can force clinical staffers to scratch their heads when so-called "queries" about the data arise later. "They still have colossal error rates," says Calder. "They spend half their time resolving queries. Novartis and PhOSCo don't get queries. You do all the checks, all the coding dialogs, right at the point of data entry. It's obvious, when you think about it. It's not rocket science."

At least one analyst thinks PhOSCo may deserve another look. "PhOSCo has an older architecture, but has a quite impressive range of functionality for an open-source application," says Judith Hanover, an analyst at IDC Life Sciences Insights, a research firm owned by the corporate parent of Bio-IT World. "The functionality is, at least on the surface, comparable to an application like Phase Forward's InForm."


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