WASHINGTON, D.C. – Today, the American Cancer Society Cancer Action Network (ACS CAN) was joined by 20 other organizations in proposing the Health and Human Services Office of Inspector General adopt a new regulatory safe harbor from the Anti-kickback Statute that would allow cli
New Report: Patients Report Increased Likelihood to Enroll in Decentralized Clinical Trials
Remote Technologies to Reduce Travel and In-Person Appointments Appeal to Cancer Patients
An article released today in JAMA Network Open details the potential benefits of using technology to increase patient participation in cancer clinical trials. In a survey of nearly 1,200 recent cancer patients and survivors, more than 80% said they would be willing to use remote technologies and tools in a trial. Additionally, willingness to enroll in a clinical trial increased—even among those who initially said they would not enroll—when told they could use remote technology and other decentralized tools to decrease the need for in-person visits and other appointments.
Adequate enrollment in clinical trials is essential to advancing cancer care and although most patients are willing to enroll in trials when asked, many encounter barriers due to travel, lodging, time off work and other challenges. These barriers are especially difficult for older adults, people with limited incomes, those that live far from research centers, and among different racial and ethnic groups who are often underrepresented in clinical trials.
The survey, done as part of the American Cancer Society Cancer Action Network’s Survivor Views project, found many patients (44%) had already begun using remote care outside of a clinical trial and reported that their healthcare issues and questions had been well addressed (95%) by the remote interaction.
“The pandemic necessitated mass adoption of remote technologies and patients’ positive experiences with those tools is increasingly reflected in their willingness to use technology in trials,” said Devon Adams, Senior Analyst, Policy & Legislative Support on Emerging Science at the American Cancer Society Cancer Action Network, and author of the article. “Expanding who is able to enroll in trials through these tools could have significant positive impact on the number and diversity of patients enrolled in trials. Researchers and regulators should take note and ensure these tools can continue to be used and are widely available.”
The DIVERSE Trials Act (S.2706/ H.R. 5030), currently before Congress, could further help expand enrollment opportunities and improve clinical trial diversity by requiring FDA to issue permanent guidance on the use of decentralized clinical trial tools, allowing trial sponsors to provide patients with technology necessary to facilitate remote participation in clinical trials as well as allowing them to cover non-medical costs associated with the trial like transportation and lodging.
“Doing everything we can to remove barriers to trial enrollment is essential to increasing participation among populations that are underrepresented, reducing disparities and to keep up the forward momentum toward improved cancer treatments and new breakthroughs,” said Adams. “This research provides more evidence that any changes to telehealth regulations must prioritize equitable patient access and we hope lawmakers consider the benefits to these technologies when addressing these important issues.”