Even before Covid-19 upended traditional clinical trial models, researchers were already harnessing the power of technology to make trials more accessible and improve data collection.
The movement is united under the banner of Decentralized Clinical Trials, or DCTs, which utilize technology and other non-traditional methods to monitor patients and collect data without geographic constraints. Another expected benefit includes the ability to recruit a broader patient population.
The pandemic has accelerated the adoption of DCTs, but it has also forced researchers back to the drawing board as they overcome the limitations of DCT models. It is increasingly clear that a hybrid approach is needed that takes into account patient perspectives and implications for clinical trial sites.
Marie Rosenfeld (Source: Astellas Pharma)
“Wherever possible, we should give patients the choice to participate in clinical trials in the way that makes the most sense for them,” said Marie Rosenfeld, senior vice president and head of clinical sciences at Astellas Pharma.
“In the early days of Covid-19, patients and researchers had no choice but to rely on technology and other non-traditional trial execution practices as the virus limited face-to-face contact with healthcare providers,” Rosenfeld said. “We’ve all taken a pretty dramatic approach to maintaining ongoing trials.”
Sponsors know a lot about the advantages and disadvantages of this approach, both for patients and trial sites.
Reach the limit
“Access to and interest in technology has proven to be one of the main limitations of DCT. Some patients struggle to use Wi-Fi consistently, while others continue to prefer in-person visits,” Rosenfeld said. She gave the example of a study of women’s health during a pandemic, in which patients felt it was safer to go to a doctor’s office than to send a health worker home.
At the same time, the trial sites ended up solving a lot of tech-related issues, turning them into de facto IT support centers, and creating issues around reimbursement.
In short, DCT is not as frictionless as you might think. “The traditional DCT concept is unlikely to be implemented as originally envisioned,” Rosenfeld points out.
Towards a mixed approach
DCTs have a place, especially for long-term follow-up and large outcome studies. But a hybrid approach—one that includes a digital element—may be more appropriate.
“At Astellas, we are developing our clinical trial approach to fully leverage the value that technology will bring in delivering the patient-directed clinical trials of the future,” Rosenfeld said. “We can improve the quality and quantity of data collected, improving the patient experience, while speeding up decision-making and accelerating the drug development process.”
The technology will facilitate more real-time data collection, providing companies and treating physicians with more actionable information early in the trial.
For example, in an oncology trial, researchers can combine the device/wearable with other non-biometric data collected from patients via an app. Combined, these technologies could allow patients to spend less time in a doctor’s office and more time at home, even in early oncology trials, while having the infrastructure to monitor and keep them safe. At the same time, the data could alert treating physicians to potential medical problems, provide researchers with more reliable information about potential side effects of products under study, and allow patients to feel safe in a more friendly environment than a hospital.
in other trials, Remote data collection may allow patients to leave the hospital earlier than would otherwise be possible.
Provide patients with the best of both worlds
If researchers are to succeed with hybrid models, they must be able to translate the technology into robust clinical execution. For Astellas, this may involve leveraging a combination of some of the external technology solutions the company has or is developing.
“We have an opportunity to leverage our expertise in traditional drug development, take groundbreaking health technologies, and apply them to clinical trials in ways that make sense for patients,” Rosenfeld said.
Rosenfeld expects it will take three to five years for fully realized hybrid clinical trial models to become the norm. The key to acceptance will be the ability to demonstrate how hybrid trials can generate useful data and gain regulatory approval.
“We believe the hybrid approach offers the ‘best of both worlds’ for patients and clinical trial sites,” she said. “We look forward to being a part of shaping how this all develops.”
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