Looking to increase the efficiency of its recently approved beta radiation trial, Novoste (Norcross, Georgia) selected contract research organization Emissary (Austin, Texas) to run the show. Emissary's TeamTrials electronic data capture technology will be used to monitor and manage the BRAVO (Beta Radiation for treatment of Arterial-Venous dialysis graft Outflow) clinical trial.
Earlier this month, Novoste received the FDA's investigational device exemption approval to use its Corona System in beginning the 23O-patient study (Medical Device Daily, July 3, 2002). BRAVO is designed to investigate catheter-based beta radiation in maintaining patency of vascular access grafts in patients undergoing long-term dialysis for end-stage renal disease.
Within seven days, the first patient was enrolled in the planned 20-site North American trial, a testament to Emissary's technology, according to Steven Mayo, its president, chairman and CEO. "Our software brings everybody together into one collaborative environment," he said, describing the collaborative relationship thrown together between a trial sponsor, the contract research firm and clinicians. "There's a lot of security limiting who can see what, but everyone has essentially the same tools. If they have access to certain information, they have the same tools to work with." Traditional trial set-u p involves a fair share of hands-on selection and FDA approval of sites, as well as recruitment of patients. During the study and after, findings are fed into a database, analyzed upon completion and eventually compiled for FDA review.
Emissary has taken a more direct approach to the entire clinical trial process. Founded in 1995, the company has developed its technology as a network of sorts. Mayo said that through free software sent to international clinical researchers, Emissary is creating a community of c1inicians. Through the association, his company sifts through its database to identify potential sites for a given study. "When we go to set up a study, we go to our software interface and look for how many sites in our network would qualify for a particular study," Mayo said. "We're basically looking into the database and getting a summary statistic from what the investigator has been collecting over the years. So in a matter of minutes, we can identify sites much faster than anyone else can."
After setting up trial sites, the TeamTrials technology manages necessary documents through an electronic an online format. The network works for doctors recruiting patients independent of a sponsored study as well, another reason clinicians have taken to installing the software in their offices, Mayo said.
From the standpoint of a sponsored trial though, Emissary allows for more effective screening of patients. "Of clinical studies that fail across the industry, 85% fail because of inadequate patient recruitment," Mayo said. ''We're addressing that by funneling more patients into a trial and increasing the chance it's going to succeed.
At the end of the trial, the analysis process is eased as the electronic data capture system allows clinicians to communicate findings with Emissary's monitors constantly throughout the study. In the end, the process takes less time than traditional trials. "Of the two or three months it takes to get a site up and running, we maybe can do that in a third of that time," Mayo said. "Of the six months it may take to recruit patients, we can often recruit patients faster. Of all the months of time on the back end in resolving the data, we're cutting that down to a few days or a week. So we're making tremendous savings on the amount of time it takes to complete the trial, and the therefore get a drug or device to market."
For privately held Emissary, the BRAVO trial marks the first use of its latest, most comprehensive version of TeamTrials. But in the past, it has proven effective for other sponsored trials. Mayo pointed to his company's handling of a trial that tested a product from CHF Solutions (Brooklyn Park, Minnesota) - the System 100 mechanical pump/filter to remove excess fluids from cardiac patients. The company last month reported the FDA's 510(k) approval.
Such history made Emissary an attractive partner for Novoste, which has employed contract research organizations in the past. "They offered the skill and expertise in running large-scale, multicenter trials," Robert Walsh, an investor relations representative for Novoste, told Medical Device Daily. "They also have rare experience in the area we're studying - the arterial venous dialysis graft.”