Improving diversity and broader participation in clinical trials could be aided by digital health and other decentralization technologies.
Clinical trials utilizing remote technology and decentralization platforms increased the likelihood patients would enroll, according to a study published last week in JAMA focused on cancer patients.
“I would say it’s not a large stretch at all to think that if we replicate this with similar questions…we probably would get similar results,” said Devon Adams, a study author and senior analyst at the American Cancer Society’s Cancer Action Network, the non-profit advocacy organization’s lobbying arm.
The group is pushing legislators to adopt a Senate bill that would require the FDA to issue guidance on decentralized clinical trials. While it has a cohort of bipartisan cosponsors, the bill remains in committee.
The space is developing and can offer patient participants a chance to participate remotely via telehealth.
“The big takeaway [was] cancer patients are interested in clinical trials, and if you make easier for them to participate, they’re more likely to participate,” Adams said.
Proponents of decentralized trials say remote trials can remove barriers to access, while potentially increasing community trust. However, decentralized trials are not likely to replace traditional means of testing and analysis.
“It’s not going to replace trials. Decentralized trials are a new set of methodologies. It’s not replacing the framework of what clinical trials are about,” said Jane Myles, vice president of clinical trial innovation at San Francisco-based Curebase, a remote clinical trial platform that recently received $40 million in Series B funding. “You’re still trying to prove efficacy and safety of a new treatment with data to support that it is appropriate for use.”
Curebase is part of a small, but growing group of platforms hoping to monetize the space. Myles said decentralized trials are still nascent, which means its funding lags other areas in healthcare.
“It’s just newer, that’s all,” Myles said. “It’s going to take a little bit of time for it to become the norm.”
The FDA released draft guidance late last year stating some technologies and remote monitoring may be acceptable.
Even if a trial satisfies those requirements, debate remains over whether the cost of remote monitoring over time is a net gain. Myles said while initial trials might cost more, she believes over time decentralized trial will result in more efficient testing.
“People are all over the spectrum over whether or not it is going to save money or add money,” Myles said. “I am in the camp that in the early adoption space, it’s more likely to cost more resources—whether money or people—because you’re learning.”
In a report published last year, consulting firm, McKinsey & Company, predicted that while fully virtual trials would remain limited, there will be an increase due to experience gained throughout the pandemic.
Correction: A previous version had the word trail instead of trial
