Since COVID-19 struck, decentralized clinical trials have been touted as a solution for many of the problems plaguing traditional clinical trials — everything from data collection to diversity to participant retention. They’ve also offered trial participants a sense of flexibility and security at a time of great peril.
But while many of the decentralized models and practices adopted during the pandemic are likely here to stay, they come with their own challenges, according to Greenphire chief commercial officer Wayne Baker, whose organization provides a wide range of support services for clinical research.
“Some of the decentralized clinical trial solutions that were perhaps not 100% ready or proven before the pandemic — folks rallied to get them to a point where we could implement them and demonstrate they would be effective,” he explained. “But with that comes a set of challenges and burdens that the industry needs to mitigate to make sure research initiatives are completed efficiently. If they’re not, we won’t be able to get some of these innovations around medicines or medical devices out to the world.”
Some of the pitfalls to which Baker alluded include:
Getting sites up to speed with new technology. Baker noted that many clinical research sites and adjacent businesses feel threatened by the possibility they might not be needed if clinical research goes mostly remotely. That’s why the industry needs to provide a greater degree of support around the necessary technologies for decentralized or hybrid clinical trials.
“Sponsors, CROs and those that are administering and paying for a lot of clinical research have advocated for sites, saying, ‘We still need you,’” Baker explained. “But it’s going to be a new world and a new era with technology involved. There’s going to be a difference in the way we’re managing protocols.”
A big learning curve for staff as new models are incorporated: Along with the technology piece comes a simultaneous need to support staff familiarizing themselves with new protocols as well as concerns around telehealth and patient privacy.
“Many clinical trial sites are seeing some constraints around personnel,” Baker said. “There’s a real challenge to retaining good staff and hiring new staff.”
Meeting regulations from afar: Clinical research is a highly regulated industry and making sure each action taken is consistent with regulations can be surprisingly challenging. Tasks that would appear to be simple, such as getting participants to sign consent forms or answering questions participants might have about those forms, can become complicated if participants are not physically present at a site.
“Where traditionally site staff may have had first-hand access to participants, now they have to make sure some of these requirements are being completed and fulfilled when they’re not gathered together,” Baker noted. “You can’t ask somebody to sign a consent form in person if they’re not coming to a physical location; it has to be completed in an electronic way.” Translated: Expect more than a few issues with communication.
Some patients prefer the in-person research experience. Even if they have access to the smoothest and most streamlined telehealth tools, it’s inevitable that some patients will prefer to see a doctor in person during their research experience. This is important to keep in mind when it comes to recruiting a diverse set of patients as well as retaining participants long-term – and it’s the biggest reason why Baker expects a hybrid model, rather than a purely remote one, to eventually become the norm.
“If participants are more comfortable to meet in person with medical staff and it helps support the objectives around patient recruitment and retention goals — which we need in order to keep folks enrolled in studies — then that’s reason number one why some in-person will always be around, versus going 100% virtual,” Baker explained.
Let’s not forget that some medical procedures are tough to administer outside a hospital or a clinical environment. “While we can do as much as we can to take the treatment or procedures to the participant, wherever they might be, there are some limitations there,” Baker continued. “It will require at least some of the protocol and requirements to support clinical research happening in a clinic or hospital setting.”