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Focus on budget issues
As each clinical trials administrator knows, it’s difficult to predict every problem and extra cost that might occur during a lengthy trial process.
"There always seems to be more work done on a project than what gets captured in the budget," says Bruce Steinert, PhD, CCRA, director of clinical trials administration at Children’s Mercy Hospital in Kansas City, MO.
But with experience and following best practice guidelines, an administrator may find that all goes as well as planned. He offers these suggestions for how to improve the clinical trials process and promote best practices in managing trials:
The institution developed consistent language over time, and it has worked well with some sponsors, he notes.
"Others will change it and renegotiate the whole thing from scratch, even if it was approved last week," Steinert says. "Whenever possible, we try to use things we already negotiated to avoid having to travel the same path twice."
The price list confirms the best price for laboratory tests, facility charges, and other routine costs.
"We know what it costs to use an examination room for an hour or two hours," Steinert says. "Our accounting department assembles those costs so we don’t get bias from investigators and others."
This pricing list is the starting point in the budgeting process, he adds.
The base budget then is compared with what the sponsor offers, and the sponsor’s study spreadsheet of scheduled activities is compared to the protocol’s language, he explains.
"Sponsors will make an initial offer of X amount per patient, and we’ll see if that fits into our budget, and we’re usually in the ballpark," Steinert says. "Sponsors try to undershoot, but we make sure our costs are met, including IRB costs, pharmacy setup fees, and our expenses for labor, so the hospital doesn’t lose money."
The biggest budgeting problem is labor, he reports.
"As we go through and develop the budget, we estimate what the PI’s time will be for various functions and break it down to a per-patient charge to figure the cost reimbursement," Steinert explains.
But there’s the challenge of capturing time when a PI may be working on several studies at the same time. So while he’s waiting for a printout on one, he makes a phone call on another, he says.
The institution builds a small cushion in the budget to cover indirect costs, so if there are any additional funds at the close of a study, the money will be used to offset unanticipated labor costs, Steinert says.
Once a contract is in place, the institution charges for its startup costs as nonrefundable, so if there are problems with enrollment, the institution will not lose the money invested in attempting to enroll the required patient population, he says.
"You can’t coerce subjects to go into a study, and there are some studies where a PI thinks it’s really important and the hospital thinks so, but patients don’t want to try it," he says. "You see that more in a pediatric hospital.
"If there’s difficulty in enrolling patients, but you have been screening patients, then you generally will get paid by the number of patients who complete or partially complete the trial," Steinert says. "If an investigator knows there will be some difficulty in enrolling patients, they will screen a lot of patients."
For instance, there may be cases where patients make it all the way through the screening process, but then a final medical test excludes them from the study’s criteria, he notes.
"We make a good-faith effort to get them into the project, and we build some screen failures in the budgeting process, as well," Steinert says.
"In some protocols, it’s difficult to enroll patients, and the sponsors understand that, so they’ll put more into the budget on their end," he says.
The way to anticipate for these problems is to bill screen failures as contingent costs and to anticipate a certain amount of these contingent costs, depending on the study and how difficult the PI thinks it will be to enroll patients, Steinert says.
A second method is to prorate the costs based on actual enrollment, collecting enough per enrolled patient to cover two or three screen failures, he notes. "If we don’t enroll anybody for the study, then we eat the costs on that method. If a sponsor is having trouble with enrollment at other sites then they’re more receptive to other screening charges, and we can renegotiate if we’re having trouble too," Steinert says. "If they’re meeting enrollment at other sites, and it’s just our population that’s not meeting it, then they’re less receptive."
A good study selection is half the battle, Steinert says.
As studies come into his office, he will find out who in the hospital might be interested and then send him or her copies to assess. If the physician answers that he or she doesn’t have the population or is too busy and can’t take on another study, then the institution turns down the study, Steinert explains. "It’s worse to accept the study and do a bad job on it. It makes us look better to know it’s not a good study for us."
This eliminates some evaluator bias, but it creates problems for a hospital where patients also are clinical trials subjects, Steinert notes.
"For our purposes, the hospital is not comfortable taking EKG results and sending these off-site without having it evaluated here, because if something turns up, then the hospital will need to address it," he explains.
"So we go to the sponsor and say, We need to evaluate it here, even if we send the results off, and we need to get that charge covered here,’" Steinert says. "And sometimes the sponsor will do it and sometimes not."
Therefore, the hospital will have to make a business decision about whether the hospital will donate the time and incur the costs to avoid having the patient suffer from something that the hospital has not discovered, he says.
"We go to the investigator and coordinator and try to get that information [about central facilities] as early in the budgeting process as possible," Steinert says. "Sometimes it’s not available until the investigator needs the test because the sponsor hasn’t decided whether to use a central site."
If study coordinators know the codes then the budgeting process moves very quickly, Steinert says.
Coders rely on what was charged and the level of billing that supports it so they won’t overcharge a payer or sponsor, he says.
When there’s a question about what the charge and code should be, the accounting department will call in coders, as well as talk to investigators and the floor nurse, Steinert adds.
"This is all done ahead of time; because once the study starts, we know the confidentiality requirement is done, the budget is done, everything is approved, and signing the final contract is the last piece on our end," he says.