Within the sprawling Loma Linda Veterans Healthcare System in Redlands, California, sits the non-profit research arm Loma Linda Veterans Association for Research and Education , and in a corner of its 54,000 square foot space in the hospital, there sits the small Clinical Research Group, hard at work on Phase III and IV projects.
The 12-person team juggles about 24 studies per year, some of which are generated by VA doctors with government funding, but most of which come in from industry, explains R. Lynne Ruybalid, managing director of the Clinical Research Group since its launch in 1997.
As small as it seems, pharmaceutical companies flock to the site. “They are one of the first sites we contact for every study we have,” says Richard Robinson, assistant director of the internal medicine, metabolism and diabetes group at Sanofi-aventis's U.S. operation.
One of the Loma Linda VA site's main selling points, says Robinson, is Alan Jacobson, assistant professor at Loma Linda University School of Medicine, associate chief of staff for research at the Loma Linda VA and a thought leader in cardiology, specifically anticoagulation research.
Another draw is the site's massive database of veterans, which clinical research staff can quickly scan for eligible subjects, generating a letter to patients on their primary care doctor's or specialist's letterhead (with those doctors' permission), explaining the study and saying that their participation would help other veterans. The group can also access patients in other VA systems around the U.S. and stay in close touch with them, as all their care comes from the VA system.
Tapping into that database has been “very effective for a lot of studies,” says Ruybalid. “We were able to get 100 patients in a summer this way last year.”
Ruybalid says the Loma Linda site alone has more than 56,000 patients in its records, with anywhere from 2,500 to 5,000 seen regularly within the past 24 months for many common diagnoses. "The data warehouse for our VA holds data in the terabyte range and beyond," she adds.
All of this makes for an unusual blend of key opinion leader and high-enrolling performance, says Robinson, adding that Sanofi offers the site about 30 studies a year. The site accepts about 10.
Keeping It Real
And the staff's sense of realism is key, too. “They are very accurate with their projections on how many patients they can get, which is so important,” Robinson says. “So many others will say, 'I can do 10,' and then they only give me two, which puts me pretty far behind.”
Additionally, the group's medical director recently developed a one-click solution called the Research Consult. It allows any Loma Linda VA doctor, while doing a consult, to click on an icon on the computer screen in the exam room if the patient who's there with them seems eligible for one of the studies currently recruiting.
Ruybalid says the Research Consult screen requires the physician to verify, by a check box, that the patient has been told about the study and the patient has given permission for research personnel to contact them. Next, the physician clicks either “paper consult” to generate a printed consult on the printer in the clinical research lab which will prompt clinical research staff to review the patient's record and contact the patient at a later date; or “page,” which immediately summons a research staff member to come to the exam room at that moment to speak with the patient face-to-face; or “study synopsis,” which takes the physician to the study synopsis, and he or she can review it with the patient.
And there's just something about veterans, Robinson says. Once approached, many say yes to participating in clinical trials—and it's not about access to health care, as all their health care is free. “I'm not sure if it's a product of serving their country, and having the sense of purpose that goes with that, and wanting to improve health care for the general population, but they do tend to say yes when asked if they will participate,” says Robinson.
The site's review board is as rigid as its recruiting is fast. As Ruybalid explains, “We don't have a central IRB; we have a VA IRB that all studies have to go through. Our IRB is very strict about informed consent forms. They have a very strict format for that, and won't negotiate much.”
Yes, research is important, but the IRB there—and the VA system overall—finds protecting veterans far more important. “Veterans aren't officially classified as a vulnerable population, but we come close to viewing them that way,” Ruybalid says. “The VA IRB is very, very interested in protecting them. We want to make sure the language in the informed consent forms is very clear and that there's no room for having the wool pulled over anybody's eyes.”
The Loma Linda clinical research subgroup got started 13 years ago, staffed by just Ruybalid herself, with Jacobson as the lone principal investigator. In 2007, the group had grown to eight employees and bought a nearby general medicine group. It also had eight employees and was handling about 10 studies a year. This allowed the group to double its study load and also to expand into therapeutic areas beyond cardiovascular.
Phase II Soon
Cardiovascular is still about half of what the site focuses on. New areas include rheumatology, diabetes, nephrology, cancer prevention, pulmonary, gastroenterology and post traumatic stress disorder. The group's structure—existing under a nonprofit umbrella that's separate from but located within a VA hospital—is not uncommon at the VA. But Robinson says few other VA-associated research groups are as organized or productive. “What sets them apart is they're very dedicated to doing clinical research, to finding better treatments for patients,” he says.
Thus far, the site has stuck to outpatient research during normal business hours. Soon, though, that will change. Ruybalid says the group will move into Phase II work within the year. “We'll be expanding our staff with people willing to work nights, weekends, longer hours, as with Phase II trials often you will need blood drawn in the middle of the night, for example,” she says.
Until then, the site remains flooded with more work than it can shake a stick at in Phase III and IV. “Sponsors always come back,” says Ruybalid. “Some come back to us constantly. We don't have to market ourselves; we always have new studies offered to us, and plenty that we turn down.”
—by Suz Redfearnd9A2t49mkex