Sponsors and CROs have gone international. Are sites next?
Michael Koren thinks so. The founder and chief executive of Jacksonville Center for Clinical Research, which has seven locations in northern Florida, this month will open an office in Panama City, Panama, becoming one of the few U.S. sites or site groups to have an overseas location.
“We all recognize that clinical trials are global now, so why shouldn’t sites be?” said Koren, who launched his research group in 1997, spinning it off from his cardiology practice.
Koren quoted a recent report estimating that 78% of study subjects in drug trials now come from outside the U.S. “The U.S. is always on the bottom of accrual rates,” he said. “It’s easier to recruit outside the U.S.” Koren considered expansion into Mexico, but quickly decided against it. “Local officials expected money every time you had a study approved,” he said. He also looked at countries that, after researching, seemed saturated by those working on trials, including Costa Rica and Brazil. Panama seemed just right.
“What we found there was a very business-friendly government, and physicians who are extremely well trained—many of whom were trained in the U.S. and are bilingual,” Koren said. “The infrastructure was built by the U.S. in the Panama Canal days. The research
industry is not overly penetrated; they have some experience with clinical trials but have plenty of room to grow. And Panama City is booming, with skyscrapers going up.”
Jacksonville Center for Clinical Research has entered into a joint venture with a two-doctor group in Panama City. Together, they will open the Pan-American Medical Research Institute (PAMRI), a new, 2,000-to-3,000-square-foot clinical research site, in early January, said Koren. The goal is to open a second, similarly-sized location within six months, he added.
The two doctors joining Koren at PAMRI are an infectious disease specialist and a family medicine physician. The small doctor group’s trial volume has waxed and waned, something Koren’s team should be able to remedy, he said.
“They’ll get two or three really good projects, then not hear anything for months,” he said. “We’re going to put in all our capacity in terms of establishing a steady flow.”
Koren said he plans to focus on vaccine studies, HIV/AIDS research, pediatrics and primary prevention at the new locations.
Koren’s group uses a unique model. About 100 doctors in clinical practice do work at one or more of his seven research sites in Florida. All work for Jacksonville Center for Clinical Research is done on the premises or at one of a handful of local hospitals—not at the doctors’ practices. “It’s like the old college professor office hours,” said Koren. “They have very specific times that they’re here.”
About 40 of the doctors are shareholders. All 100 agree to do research exclusively with Jacksonville Center for Clinical Research.
Koren plans to establish the same model among doctors in Panama, eventually gathering about 20 physicians to work from the two locations at various hours—but not in the way it’s traditionally been done outside the U.S.
“Outside the U.S., doctors commonly get paid referral fees, which is forbidden in the U.S.,” Koren said. “We won’t do that. We’ll pay doctors for their time, on an hourly basis—but we won’t send them a check for sending us a patient.” In that way, Koren said, he hopes to help shape clinical research for the better.
“There’s a push for data gathered outside the U.S. to be gathered under the same standards that it would be gathered here,” he said. “We see this as a good opportunity for us to bring U.S. standards to Panama, a little step in the right direction of creating worldwide standards. We’re excited to participate in our own little way.”
Sites opening overseas locations is unusual, though not unheard of. Miami Research Associates opened a satellite office in the Dominican Republic in 2007. Clinical Trials of America, of Eugene, Ore., two years ago established relationships with a handful of physicians in India who recruit there as needed.