DCTs And Sites: What Sponsors Need To Know
By Life Science Connect Editorial Staff
Clinical Leader Live held a webinar last August with three decentralized clinical trial (DCT) experts to discuss the history, challenges, costs, and staffing issues surrounding DCTs. Guests Jimmy Bechtel, VP of site engagement for the Society of Clinical Research Sites (SCRS); Brad Hightower, CEO of Hightower Clinical; and Karri Venn, COO, president, and chair of the operating board at Centricity Research, lent their expertise and answered questions from the audience. View the entire webinar on Clinical Leader Live.
How Did The Pandemic Impact Clinical Trial Sites?
DCTs were an available option before the pandemic, but, of course, the number of DCTs exploded in the early days of the pandemic. Sites had to pivot hard to new technologies to continue their work.
“We conducted our first virtual trial in 2015-16, so we had a bit of a head start, but when the pandemic hit, everything halted,” said Venn. “The sites had to come together and figure out new processes, new procedures related directly to not being able to see patients. For example, sites had to ensure that telemedicine portals met patient privacy requirements, and we had to figure out ways to quickly get the study monitors access to the data.”
Despite the challenges, the pandemic also created opportunities. The shift to DCTs allowed sites to work beyond their old geographical limitations and recruit patients who could complete the study from home. Sites hired remote staff, such as home healthcare and telehealth providers, to allow patients to stay home and away from crowds. The pandemic also created an influx of new technologies, including eClinical solutions and paperless systems. These growing pains led to increased popularity of DCTs, and their numbers keep growing.
What Are DCTs’ Ongoing Challenges?
DCTs offer many new prospects but can also carry a high price tag. Transitioning to a hybrid trial or DCT requires innovative technology and additional staff training. Sponsors, sites, and CROs need clear communication to manage budgets and costs. Meanwhile, the great resignation has led to staffing shortages at sites, increasing recruitment and employment costs.
“Many firsts came with this journey into decentralized clinical trials,” said Bechtel. “And the rapid pace at which these firsts came about was the root of the problems sites had that we still see today. Sites are still scrambling to understand all the elements in each trial. Sponsors and CROs need to clarify the trial’s needs and protocols to give sites a clear understanding of what is required of them.”
How Can Sponsors Support Sites?
The increase in DCTs meant that companies were hiring more vendors for different elements of the trials, requiring site staff to undergo multiple training sessions to understand how to use these new technologies, such as eClinical software, telehealth platforms, and new data collection devices. The site experts urged sponsors to consider staff training capacity when they decide how many vendors to work with and how much additional training staff will need.
Companies should also consider sites’ infrastructure needs when looking at costs. For example, demand for personal protective equipment skyrocketed during the pandemic, which increased site costs. However, site IT can be outsourced to vendors, reducing staff costs and workloads. Companies should work closely with sites to understand their needs and challenges and support them wherever possible, especially given DCTs’ complexity.
Choosing the right vendors is another way that sponsors support sites. The DCT landscape is still relatively new and evolving rapidly. Companies work with CROs and other vendors to expedite their clinical trials, but they must ensure that these vendors provide user-friendly, streamlined solutions. Otherwise, site staff are overburdened when juggling multiple systems. Companies should thoroughly vet vendors and choose the most user-friendly platforms to help sites easily manage patient care, records, and data collection.
“If a sponsor insists that we work with a person or a vendor that they haven’t fully vetted, and that person or vendor is unreliable, then it ends up reflecting very poorly on us as a site,” Hightower explained.
How Can Sponsors Keep Staff Happy?
“For trials to succeed, we must keep our physicians and healthcare providers happy,” Venn added. “They’re dealing with telehealth and virtual medicine, and now you add research complexity. We must remember their workload to ensure that DCT processes are easily adoptable and run smoothly and to recognize when bad experiences happen. We need to learn from these experiences to prepare for the subsequent study.”
In addition to keeping site staff happy, sponsors also need to consider that payroll is typically the most considerable expense for sites. One solution to meeting rising costs is to consider hiring lower-level positions for certain tasks, such as having dedicated data entry staff instead of asking healthcare providers to perform data entry. Additionally, making healthcare providers’ jobs less burdensome helps retain the highly skilled staff in high demand.
“DCTs can drive up staff costs, to a degree,” explained Hightower. “DCTs require staff with different skills than on-site trials, which can come with increased costs, especially if you don’t already have that skill set on your team. Also, inflation is affecting all of us, and turnover at sites is a huge problem.”
Tech support is another service that companies can provide for sites to help studies run efficiently. When site staff struggle with technological platforms, they need reliable support. Likewise, patients are more likely to withdraw from studies if they have difficulties using the required technology and need 24/7 support. Hightower suggests that sponsors choose site management organizations that provide patient support directly to help strengthen the relationship between patients and sites. Venn added that the quicker questions are answered and expedited, the more effortlessly the trial will run.
Do DCTs Increase Recruitment?
DCTs can increase recruitment since they draw from a much larger patient pool. However,
Bechtel and Hightower said that DCTs’ recruitment potential isn’t fully realized. Sites are still working out the logistical challenges of DCTs, and patients aren’t always aware of the advantages of a remote or hybrid trial. Also, some patients are uncomfortable receiving healthcare in their homes and would rather travel to a site. Therefore, the more sponsors and sites can iron out the challenges to DCTs, the more patients they can recruit and retain.
How Can Sponsors Help Sites Succeed?
All three panelists had tips on how companies can ensure site success. Essential elements are communication, support, empathy, and cooperation. Bechtel advised sponsors to engage sites early and listen to their suggestions.
“Stop doing clinical trials in a box,” Bechtel explained. “Talk to sites early on about what vendors and pieces of technology you’re thinking of bringing in and take time to discuss costs and resources. Companies who value partnership understand that these clinical trials on behalf of the patients are mission-critical, because no one knows their operations better than the sites themselves. No one knows the patients better than the sites.”
Venn expressed the importance of collaborating as partners and remembering that solutions aren’t one-size-fits-all. However, the panelists also praised companies already using these tools to support sites.
“I’m seeing many companies do an excellent job of reaching out to sites, getting their feedback and opinions, and some are even coming out to sites and doing deep dives into what the life of a site looks like,” said Hightower. “I would encourage more sponsors to do that because there’s so much fragmentation and silos, but if we can knock those down and work together, we can make significant changes on how research gets done for the betterment of all.”
View the full discussion on Clinical Live.