Engage study coordinators on clinical trial requirements and activities
Engage study coordinators on clinical trial requirements and activities
Optimize site performance by enhancing the role of study coordinators
It could be argued that successful clinical trials depend on a variety of factors. But perhaps the glue that holds it all together is the study coordinator. "In our hearts we know that the study coordinators play a pivotal role in the conduct of a study," said Abbe Steel, executive director, Trial Enhancements Solutions, United Biosource Corp., "but our focus is on the principle investigator."
While sites may be selected based on prescribing habits or location of the site, Steel pointed out at the 44th Annual Meeting of the Drug Information Association that the clinical trial industry doesn't focus a great deal on the study coordinator's role. According to Steel, "Studies can be enhanced if the study coordinator is properly trained, motivated, organized, and engaged with the study."
The reality for staff and study coordinators is that at many sites there's a lot of work and several protocols to juggle. "Study coordinators have many roles within the site beyond the study in the general practice," added Steel. "Therefore, the ability for the study not to be at the top of the mind of the staff is a real reason why a particular study may fall behind. Also, if the study coordinator is a novice, recruitment efforts can really be impaired."
Steel outlined several questions that play a part in the success of a site and may factor into site selection:
- Who is the study coordinator?
- What roles does/can the study coordinator play?
- What experience does the study coordinator have?
- How many studies is the study coordinator working on?
- How is the study coordinator compensated by the investigator at the site?
- What tools are available? Are they able to access them to leverage study success?
It has been Steel's experience that the most successful study coordinators are trained, motivated, organized, and engaged with all study requirements and activities. To get study coordinators up to this speed, she has found two programs to be particularly helpful.
Study coordinator workshop
Steel emphasized the benefits of inviting the study coordinators to the investigator meeting and is a proponent of creating a specialized track just for them. When there is support to invite the study coordinators, Steel develops a homework assignment specifically for them.
"So maybe two weeks before the investigator meeting, I send out a protocol synopsis with a couple of the inclusion/exclusion criteria — maybe not the whole list," explained Steel. "I ask them to identify five subjects from their own practice that they think might be eligible candidates for the study and to bring the list with them to the meeting. The idea is that they show up with some work — that they're already a part of this."
Then during the investigator meeting, Steel carves out some time to meet with the study coordinators to go over the homework.
"I ask who has paper records and who has electronic records," said Steel. "For those with electronic records, I ask how they identified these potential subjects. How did they go about it? Did they look at a diagnosis code, or drug usage? Maybe it was race or age.
"I ask the same process question of those with paper records and explore how they gathered their information because maybe they could have saved a lot of time," Steel noted. "People with the paper records usually are really jealous of the people with electronic medical records because it's clear that paper takes a lot longer. So it's things like that — things you can help them to work through."
Steel is convinced of the value of including study coordinators in these meetings. "It's absolutely critical that these study coordinators are invited," stressed Steel. "Even in complex trials that might require more than one person attending the investigator meeting, I really think it's worth it. It could be the best investment you make, bringing in that study coordinator from day 1."
Enhancing the study coordinator's role
Although the agenda at the investigator meeting is jam packed, Steel believes it's a great opportunity to learn about the study coordinator's experience. "This is the first time to have all these people together for a common reason and common cause where they can share ideas," noted Steel. "It can be a fantastic time to start to engage the site staff, and especially the study coordinator.
"I facilitate a lot of workshops for the study coordinators because they have a different role in the study than the PI. I don't want to underplay the role of the PI — some studies are heavy clinically, they're complicated," acknowledged Steel. "However, understanding and recognizing the role of the study coordinator and focusing 45 minutes on what they're supposed to be focusing on can really set the tone for getting the study started.
"From that investigator meeting, for maybe the next two to three weeks — assuming the sites are activated and you have the drug there — this is a wonderful time to build on the momentum," Steel noted. "And if you show attention and train the study coordinators, they can lead that charge and continue that momentum."
Paying particular attention to the study coordinators also provides an opportunity for the less experienced coordinators to learn from the veterans in attendance. "When you get experienced and less experienced sites in the room together they can share ideas and challenges — what works and what doesn't work. They can even do some role play," added Steel. "I find that study coordinators can get really energized and excited and see themselves as having an important role."
Study coordinator teleconference series
The other program Steel has found great success with is what she calls a study coordinator teleconference series. "I'm probably involved with 12-15 teleconference workshops right now," said Steel. "They're maybe 20 minutes in length and I bring all the study coordinators in together on a call.
"It's not a webex," Steel explained. "The idea of having to call in and log in — that's too much of a burden and they may not have web access if they're calling over their lunch hour."
Importantly, Steel keeps these teleconferences brief and very focused. "I just send out about six slides and ask them to call in, monthly, bimonthly, whatever. They share ideas about what's working and what's not working. It's kind of like the workshop at the investigator meeting but it's ongoing," she noted. "It's an opportunity for them to share ideas, challenges — maybe they've moved on to recruitment challenges — or maybe they've noticed there are problems with the informed consent. This is their opportunity to share those ideas."
Ownership and empowerment also are themes of these teleconferences. "It's always great if you can get study coordinators to speak at or host these calls," Steel added. "For example, I've even asked study coordinators who haven't enrolled a single patient to host a call. Then they get to share why they're having difficulty and others may have some solutions for them.
"I've found study coordinators really enjoy these meetings," noted Steel.
Concerns about workload and the ability to find time for these programs have proven unfounded. "I've found that even when the sites feel overwhelmed, it's not the amount of communication, it's the value of the communication. So you can call them everyday if what you're sharing will help them do their job better."
Recognition has emerged as another important component of this program's success. "I love to be able to give out gift cards to study coordinators for participating in these calls. Some sponsors have regulatory issues with this," Steel said, "but I've found that certificates are really popular too. Call it a 'Certificate of Excellence,' if you like. I'm amazed how far these certificate rewards go. Zero dollar value, but probably the No. 1 most appreciated item that we send out."
On-site initiatives
In Steel's work, she has also identified a variety of efforts focused at the site level that help the study coordinators be more successful.
• Optimize study materials: "Study materials are great," Steel noted, "but it's important to work with the study coordinators on how to use them. Maybe something belongs in the pharmacy — show them where to put them. It's not just enough to set them out."
• Develop a communication pathway: "I'll also call study coordinators and ask if they have a communication pathway established. They'll react as though I have two heads, but I want them to understand what happens from the moment that a subjects walks in the door," explained Steel.
"What happens with that subject? Do they talk to the receptionist first? Are they triaged to a particular office? Do they have to go have labs done?" Steel asked. "It's imperative to understand all the touch points as a recruitment and retention policy so no subject is ever missed while they're visiting your site, a satellite site, or visiting a clinician. Work with the study coordinators to establish this pathway."
• Consider a centralized call center: "With a call center, I'm not talking about fielding calls generated from a radio spot. I'm talking about supporting study coordinators who are overworked and working on several studies," noted Steel.
"I would argue that study coordinators love referrals, but what they don't like is receiving unqualified referrals. This takes them away from their work. And they know that with just one or two questions, they wouldn't have all these unqualified referrals sitting in their inbox. In a case like this there could be a backlash on the role a call center could play.
"Call centers need to work with the study coordinators," emphasized Steel. "It should be a collaborative effort and could really make the study coordinators feel like they can handle the stresses of the workload."
• Identify the on-site champion: Steel concluded her message by encouraging everyone to consider the whole staff in efforts to improve performance. "I'm using the term study coordinator because it simplifies the message," she noted, "but my organization is very focused on phase 4 studies and observational studies in which there might not be a study coordinator. It might be a person at the site who has been asked to help with the recruitment or operations of the study other than the principle investigator.
"The idea is to find a champion at the site, someone other than the principle investigator who is taking on this role," added Steel. "Understand what they'll be doing and help work with them. Help them work with the site staff and I think you'll see improvements at the site level."
Reference
- Steel A. How to increase enrollment in an outpatient trial. Boston, MA: 44th Annual Meeting of Drug Information Association; July 24, 2008.
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