Best Practices Spotlight
Treat each CR step as if it's the most important thing you do
Georgia research group offers advice
From the moment Southeast Regional Research Group of Columbus, GA, starts the clinical trial process to the study's close-out, investigators and clinical trial (CT) staff follow best practices.
"When we receive a potential new study, we evaluate that study through a formal feasibility process, involving seven to nine people at our company," says Jeff Kingsley, DO, chief executive officer.
"Each person looks at the study from his or her own perspective," Kingsley explains. "Does it make sense from a financial standpoint? Can it make a profit? From the marketing and advertising perspective, do we know where we're going to get patients?"
Everyone views it on a shared server and fills out a 19-point feasibility checklist. If they decide in favor of the study, then it moves forward. This group decision happens quickly.
The people who evaluate potential studies receive word of the study through an e-mail distribution list, and each person fills out his or her part as soon as possible, Kingsley says.
"The medical department will fill out their part within a half hour," he says.
If anyone neglects to do their part, everyone in the group will know it. The decision typically is made within one day.
"I believe strongly in social pressure," Kingsley says.
If one person believes the study is feasible, and another person disagrees, then the second person can write in the electronic feasibility chart why he or she disagrees and what measures need to be taken to correct the protocol's problems, he says.
Each person assessing feasibility sees all 19 questions on the checklist, and each person can contribute information according to his or her own perspective, Kingsley adds.
"At the bottom of the form, everyone signs on it electronically," he says.
In clinical trial work, start-up speed is crucial to success, and Southeast Regional Research Group has found that staff specialization makes the process faster.
"I handle all budgets and contracts, so when sponsors contact me I can have the budget and contract turned around in a day," Kingsley says. "It might bounce back and forth, but nothing sits on my desk."
When the contract negotiation process slows down, it's typically because the sponsor hasn't made a decision, he says.
"During the holiday season, everything ground to a halt," Kingsley says. "We were here on Christmas day and New Year's day, and we get patients every day of the year; 24/7 — patient care never stops, so why should research slow down?"
But the rest of the research industry did slow down, so Kingsley's budgets sat on the desks of sponsors until January.
"Sponsors do comment about how fast our turnaround is," he says.
The research organization has a formal checklist for the contracting process, as well.
"We know what it costs us to do an EKG here or to send someone to the hospital to do a CT scan," Kingsley says. "I know all of the staff costs when we look at the budget."
For instance, Kingsley can quickly determine that a particular protocol will require three hours of the principal investigator's time, and so that should be included in the budget.
Also, when Kingsley submits a budget to sponsors, he uses the sponsors' format, which helps to facilitate the process.
"We don't win every battle; everything is a compromise," Kingsley says. "There were studies where we've walked because we couldn't come to an agreement."
One hurdle is the holdback, he notes.
"Sponsors typically want to do an 85/15 split with 15% holdback, and I want a 5% holdback or zero holdback," Kingsley says. "Also, sponsors sometimes want quarterly payments, and we always move toward monthly payments."
Also, Kingsley makes sure it's specified why the site will be paid: Is the payment made automatically, or is it based on the monitor visiting and finishing paperwork?
"I want to know exactly when that monitor is coming here," Kingsley says.
The reason sponsors push for a 15% holdback is because they think it's necessary to hold that carrot over the heads of sites so the sites will complete the paperwork after enrollment is over, he says.
"In our case, I've gone to sponsors we've worked with numerous times and said, 'You know we're a site that treats this like a business, and that 15% holdback is completely unnecessary."
Kingsley also pushes for a 30-day turnaround for payment, instead of the 45 days that some clinical research organizations (CROs) use.
"I have to pay my bills in 30 days, so if I send a bill to the CRO, why can't I get paid in 30 days?" he says. "But a lot of times there are 45-day turnarounds."
While it doesn't make sense, it's not a battle that Kingsley usually wins.
One problem is that sponsors have more clout than clinical trial sites.
"The sponsors have their own professional organization, and CROs have the ACRO [Association of Clinical Research Organizations], and we need sites to be more business-like," Kingsley says.
Leverage good business practices
Also, there should be some advantage to being a professionally run site, he says.
"If you've proven that you're one of the professional organizations, there should be some benefit, maybe having an advantage in the next protocol," Kingsley says.
Southeast Regional Research Group also has a 48-hour IRB submission turnaround.
The organization no longer starts the IRB process before the contract is negotiated because sponsors were taking advantage of that, making it more difficult to negotiate the contract and budget, Kingsley says.
Once the contract and budget are negotiated and the IRB approves the protocol, then the site waits for shipment of the drug or device while simultaneously talking to local doctors about the study, Kingsley says.
"Our advertising and marketing department is moving forward on what they're doing," he adds. "We work with the advertising design, get print ads over to the printers to have tear-off sheets, and we develop exclusion/inclusion cards [for referral sources]."
The goal is to have all of this work done before the drug shipment arrives, Kingsley says.
"Our goal is always that the day we receive the drug we will enroll a patient," Kingsley explains. "Across certain indications, we do it almost 100% of the time."
The informed consent (IC) is equally systematic. A team of CT professionals meet with prospective participants in a room that's dedicated to the informed consent process. They sit at a round table and are surrounded by plants and pictures on the wall, Kingsley says.
"The study coordinator begins the process, talking about inclusion and exclusion criteria and what we're doing with this study," he says.
After discussing the study and the informed consent document, the CT staff will leave the room and give the participant time to read the IC document on his or her own for about 15 minutes, Kingsley adds.
Typically the IC process takes less than an hour, but it has lasted as long as four hours, Kingsley notes.
The CT site recently has expanded to providing informed consent in Spanish, using bilingual staff, he adds.
The goal of all of these processes is to improve the clinical trial speed, efficiency, and success by following business best practices, Kingsley says.
"We need to be treating [clinical trials] like a business," Kingsley says. "It takes 10 years and a billion dollars to get a drug to market, and much of that is spent wining and dining doctors, looking for principal investigators."
Pharmaceutical company sponsors spend a lot of money trying to find novice sites to enroll patients, and this results in a rapid turnover among new investigators and CT sites, he notes.
The entire industry's research process could be improved if more CT sites followed best practices and treated their work like a business, and if pharmaceutical company sponsors recognized these high-performing sites and gave them more business, he adds.
"We're very passionate about it," Kingsley says. "We think there are plenty of very professional sites, plenty that run their business like a business, but there are far too many that don't, and these sites will get out of research because it was too much headache or hassle."
[Editor's note: If your site has a best practice you'd like us to highlight in a future issue, please contact writer/editor Melinda Young at [email protected] or by calling (864) 241-4449.]
From the moment Southeast Regional Research Group of Columbus, GA, starts the clinical trial process to the study's close-out, investigators and clinical trial (CT) staff follow best practices.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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