Info & Opinion
February 19, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
As a large commercial site, how do you get all your investigators to truly support what you're doing? By inviting them to actually buy in.
That's what Jacksonville Center for Clinical Research did in 1997 when it spun off from a cardiology practice. “Doctors were given the choice of continuing to just be principal investigators or buying stock in the company,” says Michael J. Koren, cardiologist and CEO. “I knew some people would be interested in having just a little role and others loved idea of being really involved.”
Now, 50 doctors are financial partners in the site. Another 120 act as principal investigators only, with no financial stake. Participating doctors, according to Koren, can invest in the site for a minimum of about $10,000, and receive returns on their investment each quarter based on the profitability of the site. Owners must sign a non-compete agreement. When doctor-investors retire or move, they get bought out. "We have had relatively few cash out since the investment has been consistently good," says Koren, adding that the site's board of directors is made up mostly of its partner doctors.
Economies of Scale
The company handles roughly 150 trials a year, from Phase I through IV, and has done approximately 1,000 trials in all. Three locations are in Jacksonville, two are just north of Tampa, one is in St. Augustine and one is in Orange Park.
The doctor-owned status gives the Jacksonville Center for Clinical Research more clout than other stand-alone commercial sites, says Koren. “Being owned by physicians, we have more sway with patients, as well as access to large databases of patients,” he says.
That's part of the agreement made with partner physicians: each must be in private practice, currently seeing patients, and willing to open their databases to the site. This allows Jacksonville Center for Clinical Research to enroll very fast, Koren says. The site says it can reach “hundreds of thousands of patients” and enroll about 40 patients a day for, say, a flu study.
As part of the agreement, the Florida site's owners/investigators must dedicate time each week to overseeing research at site locations close to their practices. This keeps doctors involved with the operations of the site at a level beyond just their roles as investigators.
The site has been able to carve out a niche in conducting hospital studies, which tend to be the realm of sites within academic medical institutions only. “A lot of independent sites just do outpatient studies; the logistics of working within a hospital are different, with regulatory and logistical issues,” Koren explains. “But our doctors have the relationships with the hospitals, so we can easily do those studies, too.”
Koren was recruited by the cardiology practice that spun off Jacksonville Center for Clinical Research right out of his fellowship at Cornell Medical Center. That was in 1991. The five doctors there had dabbled in clinical trials, but wanted to get deeper into the industry. Koren came in as a fresh young cardiologist, but also as someone the older doctors hoped would build the practice's cardiology-centric clinical research arm.
To do that, Koren applied himself to a few key initiatives. First, he had staff contact as many sponsors as they could think of to let them know of the site's existence and strengths. They also attended lots of investigators meetings, doing as much outreach as possible. Then Koren focused on making sure patients got the message that the practice was going in a new and important direction.
“We put up posters and sent out newsletters trying to explain that our culture was changing,” remembers Koren. “We said, 'Philosophically, we believe in this. This is cutting-edge medicine and here's why it's important for you.' We had good results from that.”
Soon after, the site expanded therapeutically, hiring gynecologists, endocrinologists and orthopedic surgeons. Yes, cardiology was big, but Koren was aware that that might not last.
“The industry tends to move in trends,” he says. “One thing can be hot for a couple of years, then it'll dry up. If you just focus on one therapeutic area, you'll find that your resources have out-sized the work.”
At the moment, about 25 percent of the site's work is in cardiovascular disease. Orthopedics accounts for about 20 percent, and diabetes and metabolic disorders constitute another 15 to 20 percent. Another big area for the site is women's health; it has been involved in birth control and low-desire studies, says Koren.
Then Koren decided to bear down hard on all aspects of the research operation, making sure each was hyper-efficient. “I call it 'the professional approach,' ” says Koren. “It's making sure all regulatory documents are done in a set time period. Always looking at your intervals, never letting studies lag, never getting yourself in a position where you say, 'Oh yeah, we'd better get that study started,' but instead calling the IRB every day to see if you have approval, then calling to push to get the drug immediately, and starting right away.”
When Koren had all operations in place, the site spun off from the cardiology practice and Koren became its CEO and president of its board. About six years later, the cardiology practice closed.
Technology? Koren says the center tries to stay very advanced in that arena, keeping two software developers on staff. The center developed e-Trialdoc.com, a web-based clinical trial management system (CTMS) which allows sponsors and clinical research organization (CROs) users to determine recruitment feasibility at specific sites, as well as to manage trials. The system also features educational and training modules for the stakeholder doctors.
Jacksonville Center for Clinical Research has 65 employees and seven locations. The site has 29 coordinators. Turnover is very low; employees stay an average of six years, says Koren, who's currently VP of ethics and professional conduct for the Academy of Phamaceutical Physicians and Investigators (APPI).
The center isn't heavily into Phase I. “We decided against it because it's a very different business; it becomes hotel management,” he explains. Revenue? Koren won't be specific, other than to say, “We're one of top 20 independent sites in country in terms of revenue.”
—by Suz Redfearn