Sum > parts: Building a high performance CR team
Strive for shared responsibility
Most clinical trial sites rely on a group working together, but the big question is: Do they have a high performance team?
"A high performance team's total is greater than the sum of its parts," says Barry Sagotsky, MBA, owner of Magnolia Lane Consulting in Princeton, NJ. Sagotsky also is a partner of Asherman Associates, a New York, NY, firm that focuses on negotiation in pharmaceutical drug development.
Clinical trial sites, as well as sponsors and clinical research organizations, can work to create high performance teams, he says.
Members of a high performance team will support each other naturally and automatically. Their work is effective, efficient, and of higher quality than the work of groups of people placed together, but focused on their own silo or specialty, Sagotsky explains.
Here are the steps clinical trial sites can take as they strive for developing a high performance team:
1. Begin a chartering process.
"Chartering a team is something many people know about, but not too many do," Sagotsky says.
"A charter involves persons understanding the purpose of the team, as well as each person on the team understanding each other's roles and responsibilities to achieve that purpose," he adds.
Each member of the team understands the overall business purpose of why they exist as a team, and each member understands how he or she supports the team's purpose. "It's focusing on the end results first, with details being strategic and operational ways of realizing that end result," Sagotsky notes. "Also, the charter involves knowing who your customers are, who you serve, and who provides you with the information, products, services you need."
Understanding those suppliers and customer needs and interests is key, he says.
2. Keep organization's mission and goal in mind with each study.
Each time a clinical trial site considers conducting a new study, the high performance team should consider whether this study fits in with the site's overall mission or purpose, Sagotsky says.
They should address these questions:
- How important is the trial to medicine, to caregivers, and to providers?
- How important is the trial to patients, family members, and payers?
- What are the pharmacoeconomics (cost/benefit) of the treatment you are helping to prove?
The goal is for each team member, whether their role is study coordinator or investigator, etc. to keep his or her eye on the overall purpose of the organization, as well as on the goal of the study and how the team is functioning, Sagotsky says.
"High performance team members are constantly improving and focusing on the process equally with attainment of goals," he explains. "High performance team members are clear on who they are and what they do, with the team and outcomes coming first."
An analogy is the story of a person walking up to a mason chopping a brick near a huge building. The visitor asks the mason what he's doing, and the mason says, "I'm building a cathedral," Sagotsky explains.
"The gist is that if you're on a team then you're part of the bigger picture," he says.
3. Form small, team-building groups at the start of each trial or when membership changes.
Choose a leader, someone who is an experienced facilitator, and hold a kick-off meeting or an alignment with the team, Sagotsky suggests.
The trial coordinator or contract manager could fill this role. Larger CR organizations might hire a professional facilitator.
Then, CR sites could have the entire team meet to discuss and agree on their personal and team goals, roles, and responsibilities related to this trial, Sagotsky suggests.
"One activity might be to have each person write down what they think the roles and responsibilities are for the other team members and what are their own roles," he says. "You can sit in a circle, and each person can say, 'Here's what I think you do and what you're responsible for.'"
That person can then correct the others, one at a time, and negotiating when necessary, Sagotsky says.
This exercise will be enlightening for most CR employees, he notes.
"They'll find out that multiple people believe they are responsible for doing the same thing, and sometimes they find out that no one is doing something that's important," Sagotsky says.
This type of group exercise could be revisited each time a team loses or gains a member.
"A high performance team is an aspiration, but it's not really sustainable through any membership changes," Sagotsky says. "Once you've achieved it, a new study coordinator or other team member is brought in, and you have to start all over again."
The team might not start from the beginning, but the team must agree on roles, responsibilities, team norms, and especially issue escalation, he adds.
4. Focus team on thinking through their deliverables.
"We deliver clinical research results to a contract," Sagotsky says. "Many people from the CRO to the sponsor try to manage through a contract."
So it's a good idea for CR professionals to know where their site is going and how they'll accomplish their goals of delivering what they contracted to deliver to the CRO and sponsor, he says.
"I speak at the MAGI conference twice a year, and I come in touch with hundreds of people involved in contracting and running clinical trials," Sagotsky says. "And one common sense approach is that CR professionals carefully think through what the site can do and why it should do this."
For example, a site might say it will deliver 20 subjects to a trial, but if the investigator and CR coordinators do not have a clear understanding of what the protocol's inclusion/exclusion criteria entail, then they may be setting the site up for failure.
"If you have a high performance team then the person who is managing the site knows what the site can deliver," Sagotsky says. "A high performance team can negotiate better and deliver results as expected by sponsors."
Members of a high performance team know that even if they make a mistake, there will be someone else on the team ready to cover them, he notes.
"The focus is not so much on you as on the team," Sagotsky says. "The organizational culture of a high performing team includes the attitude of 'Here's how we do it; we know where we're going; we know what our processes are; we know how to execute our mission flawlessly, and if we have a flaw, we know how to fix it.'"
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