Patients may be less likely to enroll on cancer trials during COVID-19 pandemic
Click Here to Manage Email Alerts
Approximately one in five patients with cancer reported they were less likely to participate in a clinical trial because of concerns about the COVID-19 pandemic, according to a research letter in JAMA Oncology.
Of note, the data were limited by reliance on a survey of volunteers with cancer whose demographics and attitudes toward clinical trial participation may not be representative of all patients with cancer, Mark E. Fleury, PhD, researcher at the American Cancer Society Cancer Action Network, and colleagues wrote.
“Nonetheless, the difference between those less vs. more willing to participate in trials in light of the pandemic was stark, was consistently observed across evaluable demographic and socioeconomic patient groups and extended even to those who previously agreed to participate and who had the most imminent opportunity to enroll,” researchers wrote.
It is unknown whether clinical trial participation among patients with cancer will go back to prepandemic numbers once site and enrollment restrictions lift, especially if community spread is still occurring, according to the researchers.
For this reason, Fleury and colleagues surveyed 933 adults (73.1% women; 3.6% Black; 36.6% with an annual household income of $60,000 or less) about their attitudes toward clinical trial participation during the COVID-19 pandemic. Participants were included in the American Cancer Society Cancer Action Network’s Survivor Views panel established in 2019, were U.S. residents and had been diagnosed with and/or treated for cancer within the past 5 years. The majority of participants (69.1%) had one of the four most common cancers: breast (45.9%), colorectal (7.4%), lung (7.7%) or prostate (8.1%).
Researchers created questions that were incorporated into an existing survey program to inquire about participant disposition to clinical trials, willingness to participate and reasons for nonparticipation. They used 2 tests for comparison.
Results showed 33.9% of respondents reported having a prior conversation about clinical trials with their physician and 20.6% were offered clinical trial participation. Of those offered clinical trial, 78.1% agreed to participate and 60.4% eventually enrolled, corresponding to an overall trial participation rate of 12.4%.
Among those not offered clinical trial, 78.4% reported being somewhat or very likely to enroll if they were offered.
Of the 907 respondents surveyed on whether the pandemic made them more or less likely to participate in a clinical trial, most (79.5%) reported no difference whereas 18.1% (n = 164) indicated the pandemic made them less likely to enroll compared with 2.4% (n = 22) who reported they were more likely to enroll.
The most common reasons for being less likely to enroll on a clinical trial included fear of increased COVID-19 exposure (70.1%) or difficulty accessing care during the pandemic (18.3%).
Response patterns were similar across demographic, socioeconomic and care settings, researchers noted.
“The present findings suggest that as long as high rates of COVID-19 cases exist, patients with cancer will be less likely to consider trial participation even when sites return to prepandemic status,” Fleury and colleagues wrote. “The NCI and the U.S. FDA have provided guidance on increasing flexibility for trial investigators during the COVID-19 pandemic. These guidelines focus on reducing COVID-19 exposure or offering alternative care settings. Trial sponsors will need to take full advantage of the approaches indicated in these guidelines to better address patient fears about clinical trial participation while the COVID-19 pandemic endures.”
Perspective
Back to Top
Margaret von Mehren, MD
Improvements in oncology care occur as a result of clinical research trials. The survey conducted with members of the American Cancer Society Cancer Action Network’s Survivor Views panel suggests that COVID-19 may lead to fewer patients participating in clinical research studies. It is incumbent upon oncology clinical researchers to counsel patients who are proceeding with cancer care on the importance of clinical trials and to underscore the modifications being made to keep clinical trial participants safe; not doing so may result in delays in the progress on treatments for all patients with cancer.
Collapse
Click Here to Manage Email Alerts