Questions of Cost, Accountability Dominate Discussion of Trials’ Post-Pandemic Future
As the industry moves beyond the pandemic, sites and sponsors must ask themselves which practices developed to meet the needs of remote operations should carry forward and, ultimately, who will cover the cost of new technology and methods.
The telemedicine and home patient visits, remote monitoring, electronic consent systems and direct-to-patient delivery arrangements that have proven so successful in keeping trials operating during the crisis all come with additional expenses that may not be covered in current site budgets.
New methods and technology can be expensive, and site budgets haven’t changed, said Karri Venn, CEO of site network HyperCORE International. On the other hand, Venn said, some innovations that lessen the need for on-site operations actually can save money.
“I think there’s a nervousness, even as you add in virtual telemedicine, that the budgets will actually decrease,” she told attendees at the 2020 MAGI Clinical Research vConference last week. “These are real things that we have to think about” when deciding how to continue and survive.
Still, many sites say they are ready to take on the challenge of new methods. Asked who should manage direct-to-home visits, for example, 56 percent of attendees said it was the site’s job, 32 percent would hand off responsibility to a third party and only 13 percent said sponsors and CROs should have control.
At the same time sites take on more responsibility, there’s a new accountability for sponsors, and not just on the cost side, said Kathryn King, senior vice president of clinical development at Aptinyx.
“One of the things we as sponsors need to do is really be clear on what are the aspects of either data collection or data integrity that are most important,” King says.
“I think perhaps in the past … we tended to be a bit rigid about all aspects of a clinical trial,” she said. Sponsors would provide sites with the protocol and specify where and when visits had to happen, for instance, not leaving sites many choices in how to conduct their trials.
“Maybe what we really need to do now is to think about what are the most important data to be collected and how much flexibility can or can’t be provided around the collection of that data,” King said. Some assessments, procedures and examinations don’t lend themselves to the remote approach, she acknowledged, but if sponsors can provide flexibility in some areas and be a little more strict or careful in others, they can give sites more leeway in how they manage their trials.
“If we, as sponsors, can be clear what the ultimate goal is that we are trying to achieve, that then allows all of our partners and stakeholders to be more flexible in places where that flexibility is needed,” she said.
But the responsibility for change isn’t all on the side of the sponsors, said Karen Correa, vice president and head of global clinical operations at Takeda. Sites need to educate their sponsors about the day-to-day issues they face. “People are working at the site level, working with the patients … and we really need to hear from them,” Correa said. “We need for you guys to be able to give us feedback.”
That kind of communication from sites helps sponsors form the best protocols, establish the right processes and select the correct vendors, she said, “so that we can be able to recruit the patients and complete our trial. But we really need to hear from you all of the challenges that you’re dealing with and how we can be able to mitigate together.”
Another issue weighing on both sites’ and sponsors’ minds is who should be responsible for providing new technology, such as electronic regulatory and data management systems. When asked this question, attendees’ responses were divided evenly between sites and sponsors.
That discussion is still in its early days, the three speakers agreed.
“I don’t know if we have enough data right now to be able to go to that space completely,” said Correa. “But I do think that we have the opportunity for communication and relationship-building on what that would look like so that it’s appropriate when it gets out there.”
“It is a process,” Venn said, “but we’re investing in it. We feel like this will help us ultimately go forward.”
King also is optimistic about the future. “We have great tools from a technology point of view. We have the possibility of collaborating with all of the stakeholders who are part of this process — sites, patients, sponsors, regulators — and I think that enhanced collaboration really can be leveraged right now.”
“We can either get back to work or begin to work in a way that really propels our industry forward. And I’m hopeful that we can do just that.”