Better budget writing in these lean CT times
Better budget writing in these lean CT times
Consider three main types of costs
Clinical research (CR) site managers might have noticed a recent trend of being sent very tight clinical trial budgets as pharmaceutical companies and other sponsors adjust to the continuing recession.
This trend makes it even more crucial that CR sites have accurate and detailed knowledge of their own expenses and costs. Their budget-writing skills should be honed and improved to ensure they won't lose money when conducting trials.
CR sites need to know their costs and perform an analysis of study budgets regardless of whether their clinical trial is funded by government grants or commercial sponsors, says Angela Fornataro McMahill, JD, CHRC, CHC, CCRA, director of the University of California – San Diego (UCSD) health sciences research compliance program.
"You need to understand the protocol-related activities and requirements, what the standard of care vs. research for the subject population, obtain any necessary clarifications regarding the study activities, and describe specific costs per visit in detail," McMahill says.
This might require a clinical trial director to move out of his or her comfort zone since budgeting isn't an area for which there's much research training.
"Often times folks in research are not comfortable with budgeting and finance," McMahill notes.
Large research sites or academic medical centers may have specific people assigned to handling budgets, but for the average CR site this is a skill a researcher or director might need to acquire.
McMahill offers this outline of how to create an accurate and thorough study budget:
Know your overall costs.
The first step is to read, understand, and analyze the protocol to determine the study-related activity the site is being asked to perform.
Next, the budget writer should discuss the protocol with the principal investigator (PI) to make certain the site has all of the necessary equipment and supplies and to determine the amount of clinic space that will be needed, McMahill says.
The budget should be created with three separate components: start-up, per subject, and variable costs.
Determine start-up costs.
The budget's start-up costs should include every expense required as a site prepares for a clinical trial, McMahill advises.
"Make sure start-up costs include all the expenses that will be incurred specific to that trial before you enroll the first study participant," she says.
These costs may include the following:
Investigator's time;
IRB preparation time;
IRB fees;
Investigational drug (IND) service fees;
Screening costs;
Equipment purchased;
Administrative costs;
Study coordinator time;
Clerical support.
Determine the per subject costs.
The per subject costs include all of the activities required by the protocol. These include every study activity required to take place at each visit. In addition to the activities and events specified in the protocol, the per subject costs should include professional fees and staff time.
This category of expenses also includes hidden costs, such as drug dispensing fees, stipends paid to subjects, clinic fees, and direct costs, which might include utilities, rent, and other infrastructure costs.
"If you're required to perform a service in a protocol, then you should cost out what amount of time it will take," McMahill suggests.
For example, when looking at study coordinator time, a site should be careful to include both the time the coordinator spends with subjects and also the preparation and documentation time, she adds.
"We find that the study coordinator time is one of the most underestimated costs," she says. "Someone might see that the protocol calls for a one-hour study visit, and so they'll count that as one hour of the coordinator's time."
But the reality is that the study coordinator will need time before that one-hour visit to prepare for the visit and time after the visit to complete the source documents and other administrative tasks, she adds.
Each study and each site will require different amounts of this time, so the budget writer should base these estimates on previous experience.
And don't forget miscellaneous hidden costs, McMahill advises.
"Factor in stipends, travel costs, sample preparations, time to process, package, and ship preparations, bandages, alcohol wipes, needles, etc.," McMahill says.
Participant cost analysis also requires a determination of which activities are standard of care and which should be billed to the study.
"If the activity is performed solely for study purposes then we expect the sponsor to pay for it," McMahill says. "We rely on the physician to make a determination of what's standard of care versus research."
Sponsors do not dictate which activities are standard of care, because that is an institution specific decision, McMahill says.
Factor in variable costs.
Variable costs include protocol-related activities that may occur during the conduct of the clinical trial. Line items may include IRB fees for additional submissions, translation of study documents, serious adverse event monitoring/processing, responses to data queries, etc.
For example, a protocol might say that if a study participant experiences a certain type of event, then the investigator may be required to perform additional tests or services.
"If this does occur, you want to make sure you include it in the budget and receive reimbursement for the service and study team time," McMahill says.
"Sponsors may not like these, but you want to make sure if they do occur that your costs are covered," McMahill says.
One strategy is to use budget footnotes that spell out specific things like the enrollment time period and monitoring frequency so that if a study exceeds the amount of time outlined in the protocol the study coordinators' extra time spent on these tasks can be reimbursed by the sponsor, she adds.
"Say the monitor is scheduled to visit once a month but then doubles the scheduled visits, well every time the monitor visits it requires someone's time, and that time should be reimbursed," she says.
McMahill recommends drafting the budget in an Excel spreadsheet format, showing detailed lists of various items.
"I like to list details so there's no mystery about how I came up with the study budget," she says.
After writing the budget, the budget writer should show it to the investigator and study coordinator because they have a critical role in bringing in the study on budget.
Their review will help ensure that no details have been overlooked or underestimated.
"They might point out something you're missing," McMahill says. "You'll need to know their actual costs so if the PI says, 'I really need additional time, or this is not enough to cover this particular exam or service,' you can include what the investigator says into the final budget."
McMahill also recommends writing a budget before looking at the sponsor's proposed budget so you won't be influenced by cost numbers that may be too low to complete the work.
"After there is a final draft site budget, McMahill recommends comparing it with what the sponsor was offering to see if there is anything that was not included.
Ultimately, the study budget should reflect no less than what it costs the site to perform the research successfully.
"Clinical trial budgets are much leaner than they used to be, so sites have to come up with more efficient ways of starting up and running a trial," McMahill says. "But sponsors want you to succeed and bring back data, so they have to pay us to do the trial right."
Clinical research (CR) site managers might have noticed a recent trend of being sent very tight clinical trial budgets as pharmaceutical companies and other sponsors adjust to the continuing recession.Subscribe Now for Access
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