Better budgets are needed to ensure survival in competitive CR world

Experts offer tips on improving process

It's a more competitive, tougher clinical research (CR) world out there when it comes to sites keeping track of metrics and creating study budgets. Experts say clinical research organizations (CROs) and sponsors are keeping their own metrics and are returning to high-performing CR sites.

They know which sites are successful at enrolling subjects, how many queries they've received, how many protocol violations they've had, and generally how successful they've been, says Deena Bernstein, MHS, director of clinical research at Sheridan Clinical Research in Fort Lauderdale, FL.

CR sites that fail to collect their own data on their performance are at a disadvantage when they write their study budgets.

"If you're keeping these metrics and working more as a partnership with the CRO or sponsor, then you can make changes to the areas where you fell short and improve your processes," Bernstein says.

Sponsors and CROs want to contract with sites that have a track record of success, and one way a CR site can prove this is by keeping its own metrics and writing budgets that accurately predict the site's costs for a particular study.

"We're always looking to have higher-performing, highly-educated research sites that have more experience because it's in the best interest of our company," says Jim Armbrust, JD, CRCP, head of Clinical Trial Business Operation Group of MedImmune of Gaithersburg, MD. MedImmune, the biologics business unit of AstraZeneca of London, England, is a sponsor company.

Sponsors understand that they'll get what they pay for, so the cheapest site might not be the best value for a study, Armbrust adds.

"A site that has the experience might cost a little bit more, and that's okay if they're within the fair market value," he says. "It's cheaper for us to pay a little more up front than have to find a whole new site when the cheap site fails."

This is why it's becoming increasingly difficult for new physician researchers to break into clinical trial work, Bernstein notes.

"It's very difficult to land your first trial without clinical trial experience," she says. "So they'll overestimate on the sponsor's feasibility questionnaire because they just want to be awarded their first study."

But it's a huge mistake for an investigator to estimate enrolling 50 patients in three months when that number likely will prove elusive.

"There's nothing worse than getting into a study and finding out you can't enroll subjects, especially since sponsors and CROs are keeping metrics on research sites," Bernstein says.

The key is for research organizations to be proactive, do their due diligence, and perform thorough budget feasibility reviews that rely on past experience and metrics.

Also, there are a number of steps CR sites can take to improve their metrics and budgeting process. Bernstein and Armbrust outline these ideas below:

• Have separate person/staff handle contracting/budgeting process when possible: Study investigators need to be involved in interpreting a protocol during the budgeting process, but it's optimal to not have principal investigators do the contracting, Armbrust says.

For large research institutions, there could be an entire contracting group with internal lawyers involved in budget negotiation, he explains.

"The second level is a practice of three or four PIs who do this as a day job," he adds. "They have an accounts payable/receivable group of one or two people who do all the contracting and negotiating with them."

The third level are sites with investigators who have no support system and are doing it by themselves, Armbrust says.

If a CR site operates at the third level, then it's more likely the site will accept a sponsor's budget without thorough analysis and review, leaving little negotiation room.

But at the very least, investigators and CR staff should read the contract and budget carefully because once it's signed and approved, there is little chance it will be amended when the investigator discovers he or she did not charge enough for a particular procedure, Armbrust says.

• Know your per-procedure actual costs: "The way we do our budget is by listing items as per procedure or per visit," Armbrust says. "The protocol might require a certain specimen to be obtained, and if the [CR site] doesn't look at that line item and say $40 isn't reasonable for this blood draw, capture and shipment, then there's a problem."

CR sites make the common mistake of overlooking hidden costs, such as the cost of shipping a tissue sample or the cost of storing it at the designated temperature.

"This is an area that commonly is misunderstood or underestimated in a fair market value," Armbrust explains. "They may have a blood draw that we pay $40 to take and ship back, but if it costs them $100 at the end of the day, they're losing money."

Investigators who sign off on these budget items without thoroughly reading and understanding the protocol's demands will run into problems that could result in the site's failure in completing the study.

• Create bar charts with site's metrics: "We have bar charts, called visual displays, that we create and share with sites, including information on when the study starts, what our planned enrollment is for the entire length of the study, and what is our actual enrollment," Bernstein says. "We update these charts every month."

Each site has a site-specific chart that is available for all to see in the office.

By keeping metrics visible, CR sites can emphasize what's important, such as meeting enrollment goals.

"This helps keep everyone aware of what goes on at a site," Bernstein says.

• Find industry benchmarks: Even the smallest of CR sites will greatly improve their budgeting process if they invest in software or data that provides industry benchmark costs, Armbrust suggests.

"What they can assume is the sponsor will give them a range within the fair market value for their jurisdiction," he adds.

With industry benchmark data, CR sites can at least accurately pinpoint what particular protocol procedures would cost the average trial site in their region, even if they cannot identify their own site-specific costs. This means they would be less likely to greatly underestimate or over-estimate costs.

• Focus on key goals, such as meeting target enrollment: "Most budgets are negotiable, but our main concern is whether we can enroll and meet our target enrollment," Bernstein says. "This whole process is about making a commitment to a protocol, and you have to do a thorough job with details about every particular patient visit."

A clinical research team needs to dissect the protocol and analyze it for enrollment issues and obstacles. (See story on creating a study feasibility tool, p. 16.)

"The worst thing that could happen is that you accept a study and can't really enroll because some small nuance in the protocol prevents you from meeting that enrollment," Bernstein says.

• If a site determines a procedure will cost more, justify that request in writing: CR sites can return to sponsors and ask for more money in the budget being negotiated, but they'll need to defend their request in writing, Armbrust says.

"We have, as a sponsor, the duty to stay within fair market value, so if one site next to you is paid $100 and you come back and say it will cost $1,000 for that procedure, then you'll have to give me substantial information about why your costs are much more than the costs of the site next you," he explains.

The best way to handle this is for the site to be transparent and tell the sponsor what its actual cost is for a particular procedure.

In writing, say, "We are certifying that those costs are true and correct costs," Armbrust says.

Sponsors need this in written, formal language so that if the sponsor experiences a financial audit by regulators, then the sponsor has the written document showing why a particular site was paid more than other CR sites, he adds.

• Show sponsors what your institution's overhead costs are: Different research institutions can have a wide variety of overhead costs, ranging to high double digits.

"The most common question I hear is 'How do we deal with our own institution's overhead?'" Armbrust says.

Many large institutions have an overhead that is mandated to each study team running a trial, and this cost has to be tacked onto the per subject budget cost.

Sponsors will want to know what the institution's overhead costs are and see information justifying these costs in policies and procedures.

"We may ask their legal staff to put on institutional paper the reason why they have these overhead costs and give us explanations of why these are reasonable," Armbrust says. "We have to have the paper trail to give us defensibility."

But if it's an absurd amount of money, the sponsor likely will walk away and find a less costly site.

Sites that perform their own metrics and can show during the budgeting process why their costs are justified ultimately will be the more successful research sites in both obtaining studies and executing them, Bernstein says.

"Our business had definitely improved over the past year, and we're definitely getting more of an influx of studies," she adds. "We have a lot of repeat business from sponsors we've been doing business with for years."