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Small sites can thrive with CR; here's how
Financial management system helps
These are trying times for the clinical research industry, but as one small research site has shown, even a small organization can succeed at clinical trials.
"Research directors at a small site have to be able to do everything — from regulatory to finance to patient visits — because there isn't anybody else to delegate to," says Elise Hartranft, MSN, CRNP, research director at Heart Specialists of Lancaster in Lancaster, PA.
"With smaller sites you can have personnel issues," she says.
Small sites have to be careful not to understaff or overstaff, and it's difficult to know when it's time to make a personnel change, she adds.
"I have one trial with 30 patients, and this keeps a coordinator busy three-fourths of the time because there are frequent visits," Hartranft says. "People say a study coordinator should handle X number of trials, but it depends on the number of visits."
Heart Specialists runs six to eight trials at a time, and the research staff typically includes Hartranft and a part-time study coordinator.
"There is a local college where we find undergraduate students who can do six-month co-ops," she adds. "They do the faxing, filing, paperwork, getting charts ready for us for a site visit and that kind of thing."
When the site is between part-time study coordinators, the entire study protocol workload becomes Hartranft's job.
"One of the core pieces for a smaller site would be that your primary research person basically has to be a jack of all trades," she says. "There have been occasions when I've looked at study protocols and had to turn them down because we don't have enough staffing or it's too time-consuming."
Although it seems counterintuitive, one key to succeeding as a small site is learning how to say "no" to studies. Research sites can harm their financial bottom line by taking on studies that drive them into red ink on the accounting balance sheet.
For instance, the research site turned down one study where it would have required five-hour blocks of time for the study coordinator, she says.
"The question was 'Do we hire someone for this study, or do we decline the study?'" Hartranft says. "We decided we would rather decline, but we did talk about taking one of the office nurses and training them on the protocol."
For small sites, it's important to have some staffing flexibility. For instance, Heart Specialists has two nurses who can work on research projects on an as-needed basis.
"They work infrequently, and we can train them on a protocol, paying them a per-patient rate," Hartranft says. "That is our fallback."
Small sites also might decline studies based on equipment needs that are not reimbursed by sponsors.
"We had a protocol where we would need to have certain pieces of lab equipment, and we said, 'We can't do this,'" Hartranft says.
Time frames also can prove problematic to small sites.
"We'd have to think hard about a study where there's a short time window or where we'd have to enroll subjects in the middle of the night or on the weekend, like inpatient or myocardial infarction studies," Hartranft says. "A study that results in doing informed consent in a short period of time requires additional staffing, and the budget would have to be lucrative enough to cover those kinds of costs."
Finding and hiring staff can be challenging for small sites, particularly if they're located in areas where there are a limited number of research sites and research staff.
"There is not a big academic research center in our area," Hartranft notes. "In our county there might be no more than 10-15 people tops that have research experience."
This means new staff likely will need to be trained in clinical research. Since this is the case, Hartranft looks more for a set of characteristics in potential employees than for specific research experience.
For instance, Hartranft will look for employees who are detail-oriented, but also flexible.
An employee who attends to details without flexibility could turn a 30-minute study visit into a two-hour visit, which negatively impacts a study budget, she explains.
"Research coordinators have to be flexible because they could have their day planned out and then something happens," Hartranft says. "A patient ends up in the hospital, and you have to be able to adapt to that."
Small research sites also might invest in clinical trial management systems to help them keep on top of their research finances.
"Our clinical trial management system handles the financial side," Hartranft says. "It tracks patient visits, protocol deviations, and similar things."
It isn't a patient records database, she notes.
"It's financial in nature," she adds. "The system can do analysis."
For instance, as the site's studies increase, the system can analyze workloads and estimate the need and financial ability to add staff. The management system also handles stipends to subjects and can handle budget negotiation data, accounts receivable, general protocol budgets, and research staffing hours, Hartranft says.
The budgeting capability is particularly useful, she notes.
"I can look at a protocol, the procedures for each visit, and put that information in the system," she explains. "It takes information on what a person will perform and how long it will take and then adds in overhead dollars."
From a financial management perspective, it's very useful, she says.
"It's also set up where you can do projections," Hartranft says. "You can determine how much you will make in the next year based on the studies you have and how many people you think you'll enroll over time."
These projects can better inform staffing decisions.
"If it looks like we're bringing in X work, but the study coordinator an only handle this amount of volume, then that's a way to make your arguments for additional staffing," Hartranft says. "It shows that I can pay this person's salary if I enroll X amount of patients."
Another staffing and efficiency strategy for small research sites involves using inexpensive resources whenever possible. Besides having coop students assist with some of the day-to-day tasks in running a clinical trial office, Hartranft plans to teach them how to use the financial management system.
"The financial management system can do more things, but we haven't had time to put in the data," she explains. "I'm going to see what the students can do to help me enter data in the system so we can utilize it to its full extent."