One from the many: Honing multicenter clinical trials

IRB, post-grant work done

At least one research institution has found that a departmental research infrastructure is needed to make clinical trial (CT) research more efficient and feasible when multicenter CTs are involved.

The obstetrics and gynecology research network (OGRN) has a multicenter clinical trial group that includes seven different clinical trial networks that are funded by National Institutes of Health (NIH) grants and contracts.

"Most of them are being conducted at anywhere between five and 12 different hospitals that cross four health-care systems," says Michael W. Varner, MD, a professor of obstetrics and gynecology and vice-chair for research at the University of Utah School of Medicine in Salt Lake City, UT.

The OGRN is a consortium of more than 40 research personnel who administer obstetric and gynecologic clinical trial networks, including NIH-funded clinical trials in hospitals and more than 100 offices of women's health providers in northern Utah. It began 13 years ago with a staff of three, Varner says.

Running clinical trials related to obstetrics has some unique challenges, Varner notes.

"NIH has figured out that in order to have enough cases of any significant outcome and reasonable length of time, then they need to do multicenter clinical trials," Varner explains.

"There's also the fact that there is more and more required oversight compliance with various federal regulations," Varner says.

Having one office handle IRB work, subcontracting, time and effort reporting, and research activities has created a more efficient and effective process, he says.

The networks primarily receive funding by capitation: they receive a small base amount and then piece work pay reimbursement for each task, including screening, recruitment, enrolling subjects, and study completion, he says.

Tracking time and effort is complicated.

"The reality is that you have individuals working on multiple projects so there never is any down time," Varner explains.

This is what is hurting CR sites financially because they have employees who are on a fixed salary, but the sites lack the ability to accurately track time and effort and move effort per individual employee from one protocol to the next, he says.

The OGRN subcontracts with sites and receives for its work a portion of the NIH funding, Varner says.

"We're at least breaking even, although it varies from year to year," Varner says. "The only reason that we are breaking even is because we have a cadre of experienced research personnel that can shift from one project to the next as we need them to."

The OGRN focuses more on post-grant administration than on writing grants, but there soon may be more emphasis on the latter, he notes.

"The reality is that administering grants is complicated and an expensive business that has to be done in order to be in compliance, and you have to have good people to do it," Varner says. "And they have to be compensated appropriately, which takes money."

The OGRN has two fulltime financial employees and two fulltime research administration employees, plus one person handling the IRB and compliance issues.

"We're looking to add a grant specialist," Varner says. "We sent in eight NIH grants last October, and we've been writing grants on the side, so we need to add somebody whose job is to identify funding sources and help us put together competitive grants."

Enrolling for the studies poses its own challenges, but having the consortium helps create some efficiency, says Tonya K. Edvalson, BS, CIP, research compliance manager of obstetrics and gynecology at the University of Utah School of Medicine.

"Most of our hospitals don't have a dedicated clinic for obstetrics, so we rely a lot on community-based recruitment," Edvalson says.

"Our research personnel are going out to private practice facilities and enrolling from that patient base," she adds. "And we have a good relationship with clinicians in the community who allow us to recruit their patients."

The system is mostly electronic, but it's difficult to train research staff on all of its applications, Edvalson notes.

"Theoretically, they should be able to log in and pull up the information," she explains. "But it's complicated teaching them how to use it, so finding a better way to relay that information is one of my bigger challenges."

Edvalson sends emails to site research nurses and expects them to disseminate the information to their staffs.

"We have a nurse at each of five hospitals who is in charge of operations for that hospital and associated clinics," Varner says. "Some of our hospitals and some of our IRBs are not converted to the electronic world yet, and they're doing every application on paper."