Clinical Research Atlanta Site Adds Phase I/IIa Unit
Clinical Research Atlanta is expanding into phase I and IIa work. The 17-year-old, multi-specialty site just added a 3,500-square-foot building, making it the only Atlanta-area site conducting phase I/IIa work outside of the areas of oncology and psychiatry, and also outside of a hospital or university setting.
“What we’re experiencing is a transition in the pharmaceutical trials industry as we’re bringing fewer blockbusters to market—or any drugs, really,” said Nathan Segall, the site’s founder and lead principal investigator (PI). The result, then, is escalating interest in early-phase work as new molecules make their way into development.
Michelle Sowell, Clinical Research Atlanta’s clinical operations director, added that sponsors seem to want sites that specialize in specific early-phase work.
“We realized that with the changes in the economy, we were going to have to find a special niche,” said Sowell, adding that she attended a recent conference for those engaged in phase I work, and was repeatedly asked: What’s your specialty population?
The plan for the new 20-bed unit is to focus tightly on the areas of pediatrics and ailments common in African-American populations, such as hypertension work, Sowell said.
The site, which is part of the Charleston, S.C.-based Elite Research Network, is aiming for smaller studies with its new venture. “We’re not looking for studies that want 100 subjects at one time at one site. We’d rather do the ones that only want 25 subjects or so for no more than seven days,” explained Sowell. Nor is the site looking for studies that involve invasive procedures such as colonoscopies or studies that last for weeks, all of which involve far more overhead and thus cost the sponsor more, Sowell said.
Pharmacokinetic (PK) work is instead what Clinical Research Atlanta’s new unit is hoping for. “PK is really big right now,” Sowell said. “Sponsors want to see the peaks and troughs of the drug.” In addition, the site welcomes food-interaction studies.
The unit, located adjacent to the Clinical Research Atlanta’s suburban location in Stockbridge, Ga., and two blocks away from Henry County Medical Center, is staffed by workers from the site’s two other locations. The employees work in the new 24-hour unit on an as-needed basis. The new unit always has a physician on call and features an onsite lab, as well as rooms that sleep two to four people, in contrast to many early-phase units that offer one big dormitory-style room.
Segall said that the low rental prices in the Atlanta market made now a good time to launch the new unit. “We got it at 40% under what the market had pulled in two or three years ago,” said Segall, an internist and allergy specialist who still maintains a private practice.
Clinical Research Atlanta, which has two PIs, has worked on about 300 trials in its 17 years. It now has approximately 9,800 patients in its database. Sowell said the site expects its new unit to garner about eight trials in its first year.
It’s well on its way. Thus far, Segall said, the unit has accommodated one study (seeing 52 patients for a hypothalamic-pituitary-adrenal axis trial), is currently working on another (60 patients enrolled in a tobacco study) and is expecting another to start soon (a hypothalamic-pituitary-adrenal axis study in 22 pediatric patients).