Decentralized clinical trials (DCTs) exploded in popularity after the COVID-19 pandemic, and they have now become a permanent part of the clinical trial landscape. 70% of clinical research staff say they have worked on a trial with decentralized elements.
But the term “decentralized clinical trials” is still not universally understood. At the Research Revolution conference, moderator Jeff Pool began the session “Sites, DCTs, and Agile Trials” by asking “So, do we agree on what a decentralized clinical trial is yet?”
In this article, we’ll tackle what a decentralized clinical trial is, why sites, sponsors, CROs and patients are choosing them, and what the key elements of a DCT are.
What Is a Decentralized Clinical Trial?
Decentralized clinical trials use technology to bring trials beyond the walls of traditional sites and into local doctors' offices, pharmacies, and even patients' homes.
Scott Gottlieb, M.D., former Commissioner of the FDA, stated, “We see great potential in using digital technologies to bring clinical trials to the patient, rather than always requiring the patient to travel to the investigator. This is an FDA priority."
Research Revolution panelists Darcy Forman, Amanda Howley, Tyler Payne, and Leigh Burgess all agreed in their session that decentralized trials are about making trials more patient-centric. Visiting the main site for every visit can be stressful, disruptive, and expensive, especially for patients who don’t live near the site.
But there are many different visions for what a decentralized clinical trial could look like. While Forman talked about going directly to patients with technology, Payne emphasized the importance of incorporating pharmacies.
Howley added that traditional research sites, like academic medical centers and hospitals, will still be involved in many trials, but they will use technology and collaborate with frontier sites like pharmacies. Let’s explore the different forms decentralized trials can take.
"Decentralized Clinical Trials” Has Multiple Meanings
Centralized or Traditional Clinical Trial
Researchers provide treatment and collect all data from patients in a centralized location (usually an academic medical center or hospital). Patients don’t use technology at home or visit any other treatment sites.
Decentralized Clinical Trial (DCT)
Researchers conduct a clinical trial using a variety of methods. They can enroll, consent, monitor, and collect data from patients in their homes using digital tools. They can also deploy ambulatory care teams and may direct participants to regional doctors’ offices, health clinics, pharmacies, or labs for infusions and tests.
Virtual Clinical Trial (VCT)
VCTs are a subset of decentralized trials that are fully virtual. Patients rely on digital tools and devices and have no in-person interactions with researchers. Electronic Patient-Reported Outcome (ePRO) platforms, Electronic Clinical Outcome Assessment (eCOA) software, wearables, and telehealth calls are commonly deployed to facilitate VCTs.
Hybrid Clinical Trial (HCT)
In hybrid trials, researchers combine strategies from decentralized and traditional trials. Patients might visit the main research site for a complex treatment, then have a quick check-in at home or at a pharmacy.
Decentralization Doesn’t Mean Site-Less. It Means Localization
At the Research Revolution session on decentralized clinical trials, several researchers from sites asked, "Do decentralized trials mean that the sponsor will bypass us?"
The answer is no. Decentralized trials let patients engage in a mix of traditional site visits, at-home check-ins, and visits to local sites.
Researchers can now conduct trial operations at the local pharmacy, at the neighborhood pediatrician's office, and even through home nurse visits. Decentralized trials help patients who do not traditionally have the opportunity to participate in research by bringing research to them.
The Avoca Group agrees that decentralized trials are more patient-friendly, stating, “Decentralized clinical trials (DCTs) offer a more patient-centric approach, reflecting a transformational philosophy for the conduct of clinical trials in which fewer clinic visits are required and patient and caregiver burden is reduced.”
Why Are Trials Decentralized?
Decentralized clinical trials have become more common for two major reasons:
- They offer greater access for patients, especially patients from underserved groups
- They can help research sites increase their capacity
Decentralized Clinical Trials and Patient Access
Black, Latino, and Indigenous patients, older patients, and patients with disabilities continue to be underrepresented in clinical trials. This underrepresentation comes, in part, from a lack of access.
As Catherine Gregor noted at Research Revolution, many academic medical centers offer groundbreaking clinical trials–that are only available to patients in their catchment area. If patients live outside the catchment area, they must travel to the site. This excludes patients who can’t afford to take off work or pay for gas and plane tickets.
Even patients who live just an hour or two away from research sites can be excluded if they work strict hours, care for children, or don’t have a car. Because traveling to the site can be so difficult and time-consuming, patients that make less than $50,000 a year are 27% less likely to participate in clinical trials.
Community or frontier sites offer one way to solve this problem. Although only 30% of patients live within two hours of an academic medical center, 78% of patients live within five miles of a pharmacy, according to John Campbell at Research Revolution. Campbell also said that about 50% of Walgreens pharmacies lie near economically vulnerable communities.
Darcy Forman of Science 37 offered similar insights, saying that 99% of patients who tried one of their virtual trials were new to research.
Patient-facing technology won’t work for every patient, since it requires WiFi access and comfort with technology. But submitting data from home or work could work well for some patients, while visiting a primary care physician or a pharmacy could help others. It’s important to give patients options.
To learn more about the benefits of decentralized clinical trials, check out the Research Revolution session, “How Can Sites Collaborate with Sponsors to Increase Access to Clinical Trials?”
Decentralized Clinical Trials and Research Sites
Most DCTs will still involve research sites and their staff. 70% of clinical research staff said they had worked on a study that included decentralized elements, and another study found that 95% of clinical research staff had used ePRO software with patients.
- 58% of clinical research staff say decentralized trials are faster than fully decentralized trials by roughly 3 months
- 71% of staff say decentralized clinical trials speed up patient recruitment
- 81% say decentralized clinical trials cost the same as or less than traditional trials
But DCTs still come with their own set of challenges. Research sites must balance regulatory demands. They also must learn new technology and educate patients on how to use that technology.
What Are the Key Elements of Decentralized Trials?
The key elements of decentralized trials are:
- Understanding regulatory guidance around DCTs
- Planning for operational challenges
- Finding technology that works for clinical research staff and patients
While the FDA and EMA have issued statements supporting DCTs, Catherine Gregor said at Research Revolution that “FDA guidance takes a long time to come out, and we need to practice flexibility.” She notes that the FDA asked clinical research sites, sponsors, and CROs to rely on ICH Good Clinical Practice guidelines when planning DCTs.
Sponsors, CROs, and sites also need to plan ahead for the unique operational challenges DCTs present. For example, if a trial will involve frontier sites, it’s important to build strong relationships with doctors, labs or pharmacies before the trial begins.
It’s also important to consult with patient advocates about what aspects of DCTs would help them and which would just make trials more complicated.
Finally, it’s critically important to ensure the technology you use for decentralized clinical trials is easy-to-use, well-integrated, and patient-friendly.
Why DCT Technology Should Be Easy to Use
Traditional clinical trial systems can be hard to use and understand even for highly trained medical professionals. Imagine a patient with a life-changing disease trying to navigate a complicated ePro or elaborate eTMF system. It isn’t practical.
Decentralized trial technology should be designed for patients, local medical professionals who aren't familiar with enterprise software solutions, and smaller study sites that don't have any staff.
For research sites and sponsors to run DCTs successfully, they must embrace technology that's easy-to-use, simple-to-deploy, intuitive, and flexible enough to adapt to the user’s needs.
Why Interoperability Is So Important
Technology systems that don’t integrate with other platforms won't support decentralized clinical trials. Why? A software platform that's either not designed for research or forces organizations to only use one vendor will lead to duplicate work, time-consuming processes, and unfavorable outcomes.
The average site logs into more than 6 systems for each study, and 40% of sites don’t adopt new technology because they’re worried about integrations. Former FDA Commissioner Scott Gottlieb, M.D. said that investigators need to “develop new incentives that reward collaboration and data sharing across the clinical research enterprise.”
Without interoperability of technology systems, the FDA goal of collaboration and data sharing becomes difficult or impossible to achieve. And technology systems need to integrate with one another in order to share data.
Anytime you investigate new technology, ask the vendor about its integration and interoperability capabilities. An open API is a promising sign, since it makes integrations possible by letting you connect one piece of open-API software with any other open-API software. If you'd like to learn more about open APIs, this article offers a great place to start.
Prioritizing Patient Experience in DCTs
Patients often sign up for clinical trials because they want to spend more facetime with their physician or gain access to other experts.
In the words of the NIH, “Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.”
Despite the ability to decentralize many operations, patients still expect interaction with their providers and their research team.
A sponsor, CRO, or study site should be striving to maximize the efficacy of their trial while simultaneously enhancing the patient experience. This means most decentralized trials won’t be entirely virtual–instead, they’ll use a combination of technology, frontier sites, and home health visits.
The Spectrum of Decentralized Clinical Trials
Decentralized clinical trials have tremendous potential if the industry approaches them from a flexible, patient-centric perspective that combines frontier sites and technology. Want to know more about DCTs? Check out the recording from Research Revolution, “Sites, DCTs, and Agile Trials: How Do They All Mix?”, featuring experts on DCTs from Science 37, IQVIA, and CVS.
About the Author:
Blake Adams is Sr. VP of Marketing for Florence and helps to build strategies that connect Florence to the research industry. With Florence for over five years, Blake has helped to digitally connect the largest network of research sites in the world to advance cures. Connect with Blake on LinkedIn.