June 24, 2019
As clinical trial administrative tasks become more burdensome and technologies more complex, research professionals are spending more time on the business of trials than on the science. To maximize potential, academic research institutions, hospitals and other large organizations should bring all trial management and finance functions into one centralized operations hub.
Centralizing operations helps sites accelerate trials, reduce inefficiency and increase their competitiveness, said David Wynes, former vice president of research administration at Emory University. “I was always very concerned about protecting the time and the talents of my clinical researchers, both the physicians and the coordinators and nursing teams that worked with them.”
Wynes stressed that research professionals’ time should be devoted to the science of the trial rather than managing budgets, maintaining technology or handling personnel issues — all tasks that can be delegated to a centralized department that focuses on administration of all trials the institution is conducting.
Centralizing administration maximizes the potential of a research institution’s most important asset — its research team, agreed Cerdi Beltre, WCG senior vice president of institutional services. Researchers shouldn’t be building their own budgets if it can be done centrally, she said. “They shouldn’t be calling other offices saying, ‘How much is an MRI? How much is a lab test?’” A central clinical trial management system can take on that task, she said, leaving the research team to focus on the conduct of the trial.
In addition to maximizing researchers’ time, Wynes described two additional benefits of centralized operations — reduced risk and increased efficiency.
Using one centralized IRB, for instance, ensures that all sites are working to the same regulatory standards and avoiding localized missteps that can slow a trial.
“I always felt that by using a single IRB,” Wynes said, “you were sending the message that the protocol is the protocol. It is fixed. And that’s important for everyone. It’s important for the participants because those protocols have been designed with their safety in mind, but also for the research team and also for the sponsor to get the quality data that they need in order to advance with the approval for their product.”
Having standardized contract terms and review processes also eliminates risk, Wynes noted, as does central management of investigational drugs. And providing all trial personnel with the same GCP training promotes consistency in how all sites conduct the trial.
Beltre outlined four stages of establishing centralized operations. To begin, you need leadership support, she said, as well as buy-in from those affected by the change. It’s important to bring as many key team members as possible, as early as possible, into the decision-making process.
The next stage is considering what processes, staffing and resources are needed to create the new system. Then look at the type of technology available to support what you want to achieve.
“Depending on where you are and your level of maturity,” Beltre said, you may already have technology.” But it’s important to ensure that technology is supporting what you want to achieve and not just duplicating your current inefficiencies, she said.
A major decision in this stage is deciding, if you need new technology, whether you want to build it, buy it or partner with another organization that can help you assess your needs and create a system to meet them.
Wynes advocates buying tried and tested off-the-shelf solutions. “If you go with a product that’s used widely within your industry,” he said, “and you feel strongly that you need to change it, then you need to step back and say, ‘why am I so different from everyone else who’s using this?’”
“You’ve got to be very careful if you go down that path that you just don’t recreate problems you already have,” he said.
The final stage of the centralization process is looking for external partnerships that support your mission and goals, Beltre said. “It’s not just about selecting a number of vendors. It’s not about outsourcing part of your services,” she emphasized. “But it is finding a partner that will sit with you and listen to your particular needs.” The deciding question, she said, should be “are they helping you with what you want to achieve and where you want to go.”
Wynes and Beltre spoke last week at a WCG webinar. To listen to the entire presentation, click here: https://bit.ly/2J6MabT.
-By Leslie Ramsey