Avoid these common budget missteps with new studies
Avoid these common budget missteps with new studies
No upfront funds = a loss
Clinical trial (CT) sites and principal investigators can improve their budget cash flow by spending more upfront time on the budgeting process before signing contracts with sponsors.
"Sites sometimes forget the expenditure of resources it takes to get a study off the ground," says Valera Bussell, CCRC, CCRA, partner/senior clinical research associate at Clinical Research Trial Specialists (CRTS) in Parrish, FL.
This omission can be costly.
It's becoming a trend where sponsors will recruit CT sites to be add-ons to a study because the original sites have not met their enrollment goals, and the sponsor or clinical research organization (CRO) is worried the study won't meet deadlines, Bussell explains.
Then suddenly the original sites are threatened by this and they push harder to screen patients, ultimately meeting the enrollment goals. This leaves the last-on sites with no chance to participate in the study.
For instance, Bussell has worked with sites that put considerable time and energy into preparing to enroll subjects in a new protocol only to be told within a week of signing a contract with the sponsor that the trial was closed to enrollment. If they had failed to negotiate non-refundable start-up costs in the contract, then they would have lost considerable money.
"You can put all this time and energy into getting the documents, regulatory items, and confidentiality disclosure agreement (CDA), and if the sponsor shuts down the study right after giving you the study, then you're out of luck," Bussell says.
Or if a site has negotiated an upfront fee and then did not have the opportunity to enroll any subjects, the sponsor could come back and ask for a refund of the fee, she says.
"But we still expend these resources whether the study gets shuttered or not, so that doesn't work," she says.
So CT sites need to determine their own costs for start-up work and negotiate for non-refundable reimbursement, meaning it's paid regardless of whether the site enrolls subjects, Bussell advises.
Bussell offers this list of work that is done before a site can enroll subjects for a new study:
- Have the PI sign and return a CDA
- Review a protocol synopsis and complete a feasibility questionnaire before returning these to the sponsor or clinical research organization (CRO) to indicate interest in the study
- Compile and send in signed and dated curriculum vitae for site staff, as well as site questionnaire
- Participate in budget negotiation correspondence
- Submit an application to the IRB
- Attend an off-site investigator meeting
- Handle receipt, tracking, and storage of clinical study supplies, laboratory supplies, and study drug
- Complete sponsor-specific online training.
"These are all resource heavy tasks that are required before the site is ready to screen the first potential subject," Bussell says.
This is why sites need to request a non-refundable start-up fee, she adds.
"I usually ask for a non-refundable start-up fee of $3,500, and the typical approval is for $2,500, which does cover those expenses," Bussell says.
Another mistake CT sites can avoid involves advertising costs.
"A lot of sponsors are hesitant to give you much advertising money because they say if you are taking the study then you should have these patients in an internal database," Bussell says. "But you still will need someone to cold-call people on the list."
This is why sites should make certain an advertising budget is included as a line item that includes more than the actual cost of buying television, radio, or print media space, she explains.
"The ad line item should not be limited to an actual ad," she says. "It should include a recruitment cost too."
Sites also forget to calculate their overhead costs. These costs could be added to the budget in the form of a percentage of the total budget.
"I ask for 25% because it's in support of the whole operations, including copy machine, electricity, telephone, and rent," Bussell says. "Sites use these resources for the study; they're on the phone monthly with the sponsor, discussing enrollment; they have webcasts to discuss the study."
Also study coordinator and investigator training are becoming more important issues, and sponsors are asking coordinators to have compliance training and/or certification, and these all cost the site money, she adds.
CT sites can avoid these mistakes by taking a few proactive measures, including these steps:
Make your own budget: "When you first receive a protocol synopsis and evaluation flow chart, create your own budget," Bussell suggests. "I use my own templates and compare it to the budget the sponsor sent me."
If the sponsor's budget is adequate, then this comparison will confirm it. If the sponsor's budget is too low, it gives investigators or research staff information to use in negotiations.
Either way, a site's own budget provides a good foundation for comparison, Bussell notes.
Save study cost data electronically: Writing a quick budget for comparison should be a quick and efficient process, taking maybe 30 minutes, Bussell says.
The key is to save a template of typical costs electronically so these can be pulled up and plugged in as each new protocol is analyzed.
For instance, a CT site should know how much it costs to perform procedures like X-rays and ECGs, so if a new protocol lists these procedures for a particular study visit, the investigator could add those pre-determined costs to his or her budget.
"Calculate special testing based on the fee someone would have to pay cash for it," Bussell says. "Include your costs for giving informed consent, taking a medical history, dealing with concomitant medications, lab testing, drug dispensing, diaries, and all the standard components you'd have on visits."
When investigators compare their own line item costs to what the sponsor proposes and find that the sponsor's budget comes up short, they can return to the sponsor and say, "Your testing fees are a little low for this task."
Being armed with data helps, Bussell says.
"I haven't been denied a budget negotiation so far," she says.Clinical trial (CT) sites and principal investigators can improve their budget cash flow by spending more upfront time on the budgeting process before signing contracts with sponsors.
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