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Expert develops successful start-up strategy for sites
Cutting costs and time is goal
Research industry sponsors increasingly are looking for ways to cut drug development costs, particularly during the site selection and initiation process.
A strategy developed by a clinical trials advisor showed significant improvements on the product development timeline over control sites that followed conventional practices.
"The timeline and everything else was better than the control set of sites that didn't use these strategies," says Rita Viegas, BSc, MA, a clinical trials advisor for IRX Therapeutics of Brighton, MA. Viegas has spoken about her site start-up support strategy at national research conferences, and she plans to publish her study.
"Basically what I did was create a set of strategies and comparison in a small biotech company based in New York," Viegas says. "I compared metrics on how much time was saved."
Here is how the strategies work:
• Hold a prequalification teleconference: The goal is for sponsors to develop a relationship with investigators and get investigators on the telephone with study coordinators to assess how knowledgeable they are about their own sites, Viegas says.
Investigators and site coordinators were asked these questions:
—Do you have any specific review committees in addition to the IRB?
—Which documents will need to be approved?
—What processes of the start-up structure will have to be carried out in a sequential manner and which have to be carried out in a parallel manner?
—What is the typical interval for budget negotiations at your site?
—How long does your IRB take to make a decision?
—Can the contract be negotiated while submitting to the IRB?
"Then with that information, I created a timeline specific for each particular site," Viegas says.
For example, the timeline might include verbal qualifications, visit to sites, contract/budget negotiation, IRB approval, and approval by any other committee, including biosafety or oncology committees. The timeline might also include time for drug shipment and time for initiation visit, Viegas says.
Viegas would estimate how long this timeline would take, based on a typical site start-up scenario.
No sites kept precisely to their estimated timelines, Viegas notes.
"But only one site was delayed in a way that affected the overall timeline," she says. "For all other sites, the timeline would shift, but the overall timeline didn't change."
For instance, a site might predict it would take two weeks to sign the contract, and the actual time is three weeks. But the site still would be open for enrollment at the time predicted, Viegas explains.
• Encourage competitiveness among sites under consideration for study: This part of the strategy wasn't part of Viegas' study, but she would advise sponsors to use it as a strategy in site selection.
"So investigators would be aware that this was a competitive start-up, the same way you're normally aware that enrollment is competitive," Viegas says. "So if the sponsor thought 50 sites would be necessary to enroll the amount of patients needed, I'd enroll 60 sites and the last 10 would be shut down."
The process would be called the selection initiation of excess number of sites, she says.
"During budget negotiations, it's proposed that they're performing for the sponsor," Viegas explains. "All beginning activities would be paid for."
This way sites wouldn't have to fear devoting chunks of time to the project and then not be reimbursed, she notes.
"The rationale for making it competitive is to make sure you're getting the best enrollers on your team," Viegas says. "It's well known that there are sites that start up faster and enroll better."
• Create a country-specific regulatory documentation tracking tool: All countries have different requirements, so Viegas has created a tool that can be used to track all of the documents needed by sites in particular countries.
"It's amazing how many situations people find themselves in where they did everything they thought they had to and at the last minute, they stopped enrollment because something was missing that nobody knew about," Viegas says.
Viegas solved this problem with her tracking tool. As part of the process, she spoke with regulatory consultants within the countries where sites were located.
"I had one-hour teleconferences with regulatory consultants to make sure we had the regulatory document requirements for each country and nothing fell through the tracks," Viegas says.
Viegas found the right people through experience and contacts. She recommends that sponsors hire consultants within the countries to do the research about documentation requirements when necessary.
The documentation tracking tool is a one-page Excel spreadsheet that is kept in house and not shared with clinical trial sites, Viegas says.
"I would tell sites what documentation they were missing," she says. "This tool could be adapted and used in many different sizes of studies and companies and situations."
• Keep in close phone contact with site staff: Viegas kept phone numbers for all site staff, following her philosophy that a phone call is more effective than e-mail or a letter because it adds a personal approach.
"If you're on the phone with them it's way easier for them to ask a question, rather than letting them write you an e-mail to ask that question," Viegas says. "It's a way to keep the line of communication open with the site staff, and I'm pretty sure it solves a lot of problems down the road."
Snafus can be averted by a simple off-hand comment on the part of the site staff, such as this one: "By the way, can I ask you something?" Viegas says.
When Viegas called sites she would try to reach the research nurse or study coordinator.
"If there were any issues with the IRB, I'd try to reach the investigator," Viegas says. "By that time, I'd have a relationship with the site staff and know their personalities."
For instance, some investigators are happy to have someone on the phone to talk with them, and some others don't like to be bothered with a call, she says.
"I'd keep notes on all investigator personality traits," Viegas says. "If an investigator doesn't like to be bothered, then I'd drop him an e-mail."
• Provide additional training as needed: Investigators and some site staff had been trained collectively, but some individual training is necessary, Viegas says.
"I'd conduct training at the site according to the site's standards, so they wouldn't have to adapt or interpret anything I was saying," Viegas says.
It only takes about 30 minutes during the training program to adapt a few things to the specific site, she notes.
For instance, each clinical trial site had different pharmacy logistics, so Viegas would try to find out who received the investigational drugs.
She'd find out the answers to these questions:
—Are there any additional drugs that go into the regimen?
—Are the drugs bought locally?
—Does the sponsor have to supply the drugs?
—What is the line of communication to have the drug available to the principal investigator?
"Those logistics vary a lot at every site," Viegas says. "That's the kind of information I'd collect during the site qualification visits."
Then she'd outline the information on training slides, adding names of actual people and their roles within the process.
"That was particularly important for the study," Viegas says. "I was preparing them."
For example, if the investigational drug was frozen and had to be prepared for shipping and then sent back to a local lab to make sure the temperature was stable, it would require extra staff logistics, and Viegas would train the clinical trial site staff about who would be responsible for unpacking the drug and sending it back, etc., Viegas explains.
The training is also people-specific with separate training meetings for study coordinators and research nurses, Viegas notes.
"The goal was to explain the drug mechanism of action and all the background knowledge of the drug in a language that the audience would understand," Viegas says. "So we would have our medical advisory people in the sponsor company deliver training to the principal investigators so they would speak the same language."
The training was provided MD to MD, she says.
"Our project managers and clinical team leads would conduct training for research nurses and study coordinators, so it was clinical operations people speaking to clinical operations people," Viegas adds.
"We understand that they will only enroll patients if they believe in the drug, so we wanted them to understand the mechanism of action and how it works," Viegas explains. "We did not want to hear, 'I heard it works, but I don't understand how.'"