Develop a study feasibility process that makes budgeting a cinch

Create a feasibility tool

Clinical trial sites can improve their budgeting process by developing a good study feasibility process. Sites might use a feasibility tool to help prevent the site from underestimating a clinical trial site's costs for any particular protocol.

Feasibility tools can help a clinical research (CR) site determine if a study should be given a green light, says Deena Bernstein, MHS, director of clinical research at Sheridan Clinical Research in Fort Lauderdale, FL.

"We developed a feasibility tool from scratch," Bernstein says. "We sat down and looked at all that was important when accepting a protocol, and then we developed a form initiated by a study coordinator and principal investigator."

Here are some key features of the feasibility tool and process:

• Overview: The first step is a brief overview that might be accomplished within 48 hours.

"It's a quick assessment that should take the study coordinator and principal investigator (PI) half an hour to do," Bernstein says. "They look at the study objectives, patient populations, inclusion/exclusion criteria, and protocol-related procedures."

After reviewing all the criteria, the PI and study coordinator need to decide whether they should continue pursuing the protocol.

If the answer is "No," then the investigator should state the reason why the study wouldn't work for the site. If the PI and study coordinator decide the study should be pursued, they should send their recommendation to the central office or next level.

• Dissect protocol: Once everyone agrees to pursue a protocol, the project manager or another designated person will notify the sponsor and move forward to the next step of dissecting the protocol.

Now it's time to do a more complete review of the protocol, assessing it for details about the study population time frame, special pre-treatment procedures, post-treatment procedures, expected adverse events, special equipment needed, outside vendors used, and other items in the contract, Bernstein says.

It's important to note all procedures that must be done for the study, but which are not performed in clinical care setting, she adds.

"Also, be accurate on the compliance aspect," Bernstein advises. "Studies can be quite complicated, and we have to make sure we're billing patients' insurance correctly."

A budget should list procedures that are standard of care and those that are not standard of care.

"Then, we really want to know what the physician and study team believe they can enroll per month and per year in a study," she says. "If there are some problems and issues they've identified in the protocol, we want to know about those so we can go back to the sponsor early on and address those concerns with possible amendments."

• Ask for projections from study team: "We want the study team to give us projections," Bernstein says. "We have a feasibility tool in place."

If the team's projections prove inaccurate, the research site can find out what went wrong and try to correct the mistake for future study feasibility processes.

Sometimes a site's past experience with enrolling a particular study population fails to predict future experience because of an unpredictable change in circumstances.

For example, an ob/gyn site might agree to do a study involving amniocentesis. Such studies had good enrollment trends in the past, but this study team failed to anticipate a change in climate for the procedure. Pregnant women were less interested in amniocentesis now than they were previously, so the study's enrollment might flounder, Bernstein says.

The same study might have great enrollment at a maternal-fetal medicine office where women at high risk for pregnancy problems are seen. So when this mistake is discovered, it might be possible to find an alternative way to achieve the necessary enrollment.

But the key point is the study team made an error by not looking at the ob/gyn office's data to determine that amniocentesis is performed less often now than previously.

• Create a recruitment plan: "It's the study team's responsibility to create a recruitment plan," Bernstein says. "Once they've determined the plan, the project manager will meet with the study team and go over the details."

The recruitment plan includes the advertising campaign and might address all parties involved in executing the plan, including vendors, sponsors, and the IRB.

"The goal is to be up and ready at the study's starting date," she says. "You don't want to wait, because enrollment is so competitive these days and you want everything ready to go at the site initiation."

• Do a post-mortem: After a study is completed, it's a good idea to look at what worked and what did not work well.

If a study failed to do as well as projected, then ask these questions:

— Why didn't it do well?

— Was there something we did to prevent it from doing well?

— If so, what are we going to do to change the process?

If the post-study analysis shows that there was no way of anticipating this particular problem, then the CR site will need to keep in mind that this is the type of protocol that likely will not work for this site.

"This is something you want to realize early in the feasibility process; you want to catch it upstream," Bernstein says.

"If you don't have a great study population, then you won't make it, because the patients aren't there," she adds. "So don't accept a study if you can't enroll; this is greatly appreciated by sponsors, and they'll remember you in the future."