When thinking of the term bottleneck, the study-specific confidential disclosure agreement (CDA) comes to mind for many who work in clinical research, followed by site feasibility forms.

Those confounding but necessary documents create all manner of frustrating delays, says Edward Stepanski, chief operating officer of Accelerated Community Oncology Research Network, a network of oncologists that started a related contract research organization (CRO) two years ago.

“Say you have a Phase II breast cancer trial. You may need sixty sites, but to get the trial started, you have to contact hundreds to tell them a little bit about the protocol and send them a CDA. And there has to be a trail: You have to track when you sent the CDA to whom, when they responded, and then follow-up with individually generated emails or phone calls trying to round up those who didn't respond. Then you send them long feasibility forms that they fill out providing specifics about their site.

Faxing Chaos

“It's very human resources intensive, requiring a whole lot of your people to touch it,” Stepanski continues. “And it takes a lot more time than anyone would like.” That's why Acorn developed Site Tracking And Recruitment (STAR), a system that expedites the CDA process and site feasibility assessments.

Instead of sending CDA individually to sites via fax or postal mail, the system emails them all at once, with a hyperlink to the CDA. Sites sign and submit the forms electronically. STAR keeps track of which sites have signed. “It leaves a nice e-trail of all transactions,” says Stepanski. Best of all, the system knows which sites need to receive more detailed information that can include a feasibility form.

The also completes and submits the feasibility data electronically. The system then automatically generates email reminders if more details are required, or if the site fails to fill out something. Each site's feasibility details remain in the database; for subsequent studies, the same lengthy forms need not be filled out again. The site only needs to update feasibility details when necessary.

This saves sites a tremendous amount of time, says Stepanski, formerly a principal investigator. “A big research site could be offered a dozen studies a week,” he says. “They pour over the fax machine and before you've even been able to figure out which is a study you want and which isn't, reminders are coming.”

Email Emphasis

For investigators, the system greatly reduces all that paper-based fussing with faxes, spreadsheets, manual data input and follow-up phone calls. On the sponsor or CRO end, it's just a point and click. For the first time, says Stepanski, all people involved in the start-up process are able to work from a common platform, not multiple spreadsheets.

“It's an idea whose time has come,” he says. “People now do all their work through email, and in the last few years there's been a shift toward electronic signatures and conducting business through web portals. It's just time.”

The more sites a CRO or sponsor needs to contact, the greater the savings inherent in using STAR, Stepanski says. He estimates that the system can save a sponsor or CRO about 80 percent of the costs of human resources associated with study start up.

The system creates a real-time report. When a sponsor wants to check the status of site selection, it can do so without any run-around or delay. The sponsor also can see why a site might be saying no to the study, which can be valuable information. “It helps to know the reasons they are out,” says Stepanski. “Is there some barrier to conducting this trial? Are there dominant competing trials out there? Or is something wrong with the protocol?”

Match Maker

Stepanski adds that STAR also helps match the right investigators with the right studies. The system encourages investigators to detail areas of special interest or expertise when filling out the feasibility form. The system tries to match future studies with investigators in those areas. “There tends to be inertia out there about change,” Stepanski says.

Acorn's network and CRO use the system with the approximately 650 sites it approaches for studies. The firm's developers started working on it last October. It officially went live June 1. So far, Acorn is just using STAR internally.

External Users

“We hope it will improve efficiencies for sponsors and make them more likely to work with us,” says Stepanski, but he adds the company could be ready to license it to other CROs as early as the third quarter. Stepanski says the system is best suited to CROs or sponsors who work in one therapeutic area, as ACORN does, or just with the same sites.

Launched in 2002, Memphis-based Acorn, a network of 150 oncologists, naturally gave birth to the CRO with the same name. “We had a big portfolio of investigator projects being done through the network,” Stepanski recalls. “We monitored all of them, we wrote the protocols, collected the data, have our own electronic data capture, analyzed the data, and published it. Sponsors said, 'If you can do that for this one trial you're doing with us, you can also do it for a lot of our other trials.' ”

Acorn focuses mostly on Phase II trials, exclusively in oncology. Nothing global, just trials in the U.S. It has been very busy, Stepanski says. Most clients, surprisingly, have been big pharma companies that like to work with smaller CROs when it comes to Phase II trials.

Minimum Threshold

“Sponsors don't get the same efficiencies on smaller trials from the normal CRO partners,” says Stepanski. “These trials might be 60 to 200 patients. The overall budget to conduct that work is lower. The bigger CROs have a minimum threshold—if there's not $8 million budgeted, it's beneath where they like to go.”

Acorn's CRO has done eight trials. In addition to the 150 doctors at 25 sites that participate in the network, it has contracted with 250 other sites. It has 30 full-time employees. There are no plans to open any offices outside the U.S., but Stepanski said the firm is looking to partner with another similarly sized CRO with a good track record in Latin America or Europe. The driver: recruitment. “It's getting harder and harder to fully accrue a study in the U.S., even if it's just 200 patients,” he says.

The firm also has a proprietary, web-based electronic data capture (EDC) system called Guardian EDC. Guardian is two years old and was developed after exposure to many other systems in the field.

Plug, Play

“We've seen every EDC ever deployed, so you know which things are really clunky and which aren't,” Stepanski says. The claim to fame for Guardian, he adds is that people who use it say it's the most user-friendly EDC they've seen. It's used by about half of its CRO clients—those who don't already have a contract with an EDC vendor.

The development team is working on building it out, hoping to make it available to non-clients in 2010. “We're working to make it more of a plug-and-play product, where a client can program it through pull-down menus, and cut and paste to create their own EDC in house, but within the system. We're working hard to get the study-authorship piece built out.”

Even in this economy, Acorn's CRO expects 20 percent growth over the next year. But being small, that's not hard to do, laughs Stepanski. “You just add one and a half trials and that's 20 percent growth.”

—by Suz Redfearn

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