The use of decentralized clinical trials (DCTs) has become increasingly common, especially over the past 18 months. The COVID-19 pandemic made it dangerous to leave the house, particularly for patients with weakened immune systems. Since the start of the pandemic, the meaning of decentralized studies has evolved and new technologies have been introduced to accommodate trial leaders.
The past few years have ushered in a period of intense change for researchers and many life sciences organizations are still working to keep up. Here are a few ways technology is moving DCTs forward and how medical professionals can adapt.
Everyone Has Their Own Definition of Decentralization
One of the biggest challenges facing DCTs, and therefore the adoption of decentralized clinical trial technology, is the very definition of the term. Almost every organization has created its own guidelines, which means decentralization looks different from trial to trial.
“We face a digital Tower of Babel, where the terms that one person uses with confidence can be easily interpreted differently by others,” write Amir Kalali and Craig Lipset, co-chairs at Decentralized Trials and Research Alliance. “The term decentralized trial encompasses a range of solutions that include digital tools for capturing consent data, the use of home health providers, direct-to-patient drug distribution, remote monitoring and diagnostics, and the use of local labs and imaging centers.”
While the flexibility of this term can be a good thing as it allows trial developers to choose processes that work for them rather than following a strict set of rules, it can also hold some trials back if they lack the necessary technology and resources to collect the right data.
Technology Issues Lie With Researchers, Not Patients
One common mistake with DCT technology is putting the burden on patients. It’s easy to claim that patients won’t understand the digital tools or will lack access to them. However, this is simply a myth and dismissive of the natural technology use of most modern adults. One survey found that the problem lies in the clinical research organization, not in patient skills.
“Our survey results show that clinical trials organizations find that cost, complexity, and finding the right technology most challenge digital adoption,” says Francesca Properzi, director of research at DT Consulting. “At least 43% of clinical trials are still not using digital tools to support their studies.”
Properzi notes that only a few survey respondents said patient digital literacy and access were their main barriers to digital adoption.
Other studies have yielded similar results. The team at Clara Health reported on a Tufts study which found that 55 percent of clinical trials have moved to virtual since the Spring of 2020, but 60 percent of investigative sites “reported having no prior experience with remote processes and solutions before the pandemic.”
“This is a moment of great opportunity; it’s also a moment that could lead to inefficiency and deteriorated patient experiences due to the poor implementation of new ideas,” the team at Clara Health writes in its white paper, “Patient Centricity in the Era of Decentralized Trials.”
The lesson here is that researchers should not underestimate patients or write off technology as being too complex for the average person to use. Instead, they can invest in tools and training so both their staff and clinical trial participants can keep up with the changing DCT model.
Researchers Are Spurred to Use New Technologies
Throughout the COVID-19 pandemic, many researchers have gone above and beyond to adopt new forms of technology. This is creating a renaissance for clinical research organizations that are investing in technology and adjusting their budgets to modernize their existing tools. Companies are advancing their systems within a few months when new technology adoption usually takes many years.
“This change [toward DCTs] can mean adopting, and adapting to, new technology that was previously viewed by some as unnecessary or too time-consuming to learn and employ,” writes Rosamund Round, vice president of the patient innovation center and decentralized trials at Parexel. “Innovation and ingenuity blossom during challenging times, and utilizing DCT techniques has become a critical part of patient care and safety monitoring.”
Researchers understand the opportunities available because of decentralized clinical trials. As they invest in more technology systems and employee training, they can continue to grow their capabilities and reach new patients. It is just the beginning of what is possible for DCTs, data management and patient comfort.
Images by: pressmaster/©123RF.com, stylephotographs/©123RF.com, National Cancer Institute