Decentralized clinical trials (DCTs) are changing how researchers evaluate treatments. However, these trials vary from organization to organization. Different levels of technology contribute to how decentralized a trial is, with more adaptive systems offering better flexibility.
The success of a trial isn’t based on its technology use, but the right tools can improve data and provide greater insights to researchers. Systems with remote capabilities, such as those used during the pandemic, are examples of tools and resources that can be adjusted to meet new challenges. Learn more about the use of adaptive technology in decentralized clinical trials and how it is moving the clinical research industry forward.
The concept of decentralized clinical trials isn’t new. Some researchers have been creating DCT practices for years. However, the term itself is recent and its use has seen exponential growth in the past year.
“Spurred in part by the ongoing COVID-19 pandemic, DCTs are bringing more technology to clinical research and along with it the promise of greater efficiency, productivity, and effectiveness,” says Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP). “But to fully realize that potential, roles will need to evolve and operate differently to accommodate this new environment.”
Kremidas said this with reference to a white paper launch by the ACRP to prepare clinical trial leaders to use the adaptive technology created for decentralized trials.
Indeed, it seems like more organizations are prioritizing DCT investment in 2021, where new technology purchases and team training might have been pushed to the back burner 15 months ago.
“Once seen as a gimmick, the COVID-19 global pandemic has made [the virtual, decentralized trial] into a necessity,” says Ben Adams, senior editor at FierceBiotech. After March 2020, “the FDA swiftly announced new guidance saying, where possible, many trials should be switched up to a virtual model to keep research moving. This helped open the floodgates.”
As regulatory bodies issue guidance on DCTs, it creates a snowball effect moving them forward. Companies are more willing to invest in DCT tools now that there are rules for them, while industry organizations can develop best practices based on what researchers learn in their new programs.
Decentralized trials would be much harder (if not impossible) without the technology that most consumers have at their fingertips. These advances, paired with industry-specific adaptive systems, are driving DCTs to become more common and possible in different research fields.
“Implementing all of the elements needed to ensure compliant and seamless decentralized trials requires a technology platform that integrates all aspects of trial operations and execution, from site selection and monitoring to patient interactions and study closeout,” writes Mamta (Trivedi) Hunt, vice president of quality and pharmacovigilance at Biorasi.
Most research organizations use a variety of tools to collect and analyze data including machine learning systems and IoT data-collection services. “IoT-powered smart devices are perfect for clinical trials in that they enable multi-point, omnichannel workflows,” says Kenyatta Cosby, owner of Heritage Biomedical Communications. “This new approach delivers a consistent, reliable data flow from the patient to the researcher.”
The data then comes together in a central hub for researchers to review and base their publications on. This is where adaptive systems come in. They help curate the information and bring the most important elements to the forefront.
While technology and DCTs are inseparable, not every clinical trial needs to be completely hands-off. Even minor additions of monitoring tools or digital reporting devices can have a major impact.
“It’s important to note that decentralised trials exist on a spectrum,” says Christopher Kennedy, COO at mdgroup. “If introducing a fully decentralised model where patients never have to set foot in a clinical site isn’t possible, it doesn’t mean your studies can’t or won’t benefit from incorporating some virtual or at-home elements.”
This is why the use of DCTs will continue to grow. Researchers will continue to seek out new technology solutions to answer the questions they have.
While the rise in popularity of DCTs has provided new opportunities for research organizations, it has also created confusion. This leaves clinical trial leaders wondering if they should pursue DCTs now or wait to see which tech tools and practices prove their value.
“Many organizations will waste their energy by going in many different directions without a clear vision,” says Patrick Nadolny, head of clinical data management at life sciences company Sanofi. “Many do not fully understand the technology or how to leverage it. Unfortunately, for those companies, the end result will be proof of concepts that fail to show value.”
The reticence to adapt isn’t just related to technology. Clinical trial firms also need to train employees on the relevant tools and adaptive systems needed for DCTs.
According to a survey by the Pistoia Alliance, 30 percent of life science professionals say their organizations lack people with the right skills to navigate the world of blockchain and AI. Additionally, survey respondents ranked a lack of industry standards (19 percent) as another challenge to moving forward with the future of clinical trials.
“Modernization almost fully depends on the infrastructure already available at the site,” says Brenda Reese, head of North American business development at PSI CRO. “And infrastructure varies greatly from site to site and state to state. In fact, there is no standard that every site abides by when it comes to the exact amount, type, or depth of technology available.”
Within the next few years, there should be a push for greater training as organizations look for adaptive systems that are also intuitive and user-friendly for their team members.
The lack of consensus on DCTs is driving industry leaders to create guidelines and best practices for companies to follow. In December 2020, the Decentralized Trials & Research Alliance (DTRA) was launched. More than 50 organizations from various parts of the clinical trial process have joined, allowing the industry to form a set of guidelines for moving forward with this type of trial format.
“We face a digital Tower of Babel, where the terms that one person uses with confidence can be easily interpreted differently by others,” explain DTRA co-chairs Amir Kalali and Craig Lipset. “Without a common lexicon, it is easy for some people to be dismissive and conclude that new approaches like this are impractical or aren’t feasible for their work.”
The formation of the DTRA wasn’t a moment too soon. While organizations relied on virtual trials during the pandemic, many researchers are wondering if it is safe to pursue these processes and technologies in the future.
“As the industry moves to greater adoption of digital technologies and remote visits in clinical trials, it can be difficult in the early stages to be confident in choosing providers that will not only provide the best technology/service but also protect the patient’s privacy while providing data in the right format at the right time,” the team at The Avoca Group explains. “Also, without clear regulatory guidance, how can you be certain that adopting DCT principles will not risk the success of your submission?”
Furthermore, these adaptive technologies and practices need to prove their worth to the financial side of the organizations. Companies won’t invest in these tools if they drive up their expenses without also improving revenue streams.
“Any effective digital innovation must positively and significantly impact time, cost, quality, or some combination, in a measurable way, to justify the total cost of implementation — overcoming both the switching barrier and providing sufficient incremental value,” says Jeffrey Handen, director of R&D Strategy and Planning at Bristol Myers Squibb.
Decentralized clinical trials can be incredibly powerful systems to move pharmaceutical development forward. However, CROs need adaptive technologies and employee training to make the most of them. With the right guidelines and best practices in place, firms can utilize DCTs and the tools related to them for better patient experiences and clearer trial results.