While the weakening economy has forced some drug companies to cancel or delay early phase projects, at least one company has seen a growing need for its niche phase I drug development services.
Dallas, Texas-based Metroplex Clinical Research Center (MCRC), which specializes in rheumatology studies, recently expanded its services to include phase I capabilities for clinical trials on patients. In the past year, the company has seen an increase in drug companies that want to conduct phase I studies on patients who are afflicted with different rheumatological diseases (e.g., rheumatoid arthritis, lupus and scleroderma) rather than healthy patients.
“[Drug companies] want to try to begin to define the dose range of their drug and look for signals of side effects and also get a hint of efficacy. That’s why they’re choosing to treat patients who actually have the disease,” said MCRC medical director Stanley Cohen, M.D.
Under the medical leadership of Cohen and Roy Fleischmann, M.D., MCRC has conducted more than 800 clinical studies since its founding in 1984, but the organization only began doing phase I studies last year. MCRC currently has four phase I studies in the works and an additional five coming in 2009, according to chief operating officer Sara Hibbard.
“Now that we have had this experience with phase I, and it has gone so well and been such a positive thing for us, we’re really going to be expanding our phase I facilities,” Hibbard said.
Headquartered on the campus of St. Paul Medical Center at the University of Texas Southwestern, MCRC is preparing to expand its phase I space (which currently sleeps two to four patients) in 2009. The organization will also make staffing changes to meet the increased demand for their services.
“One of the challenges for these phase I studies is that you can’t plan as you do for phase II through IV studies in terms of how you’re going to recruit and how you’re going to staff it because of the structure of them,” Hibbard said. “[Investigators] may dose two patients and then do a safety analysis that might last a month and then they call and you have to be ready on a dime to start screening again.”
MCRC has used temporary as-needed personnel while researching the best way to staff their phase I unit. Hibbard predicts that the research center will transition some split-shift staff to full-time by April 2009.
MCRC’s 30-year operating history provides them with a large pool of potential clinical trial participants who are loyal to MCRC and its physicians, Hibbard said. This reduces the number of no-show and drop-out participants in any given study,making the research center’s services more attractive to pharmaceutical companies conducting clinical trials.
Cohen predicts sponsors’ interest in MCRC’s niche phase I services will continue to grow.
“At least in our field for now—and this may change tomorrow—we are seeing a lot of activity with a plethora of new molecules as we continue to understand the immune system. The difference we’re seeing over the last several years is that companies are making the go/no-go decision very critically after phase II or even mid-phase II trials,” he said.