COVID-19 Pandemic May Impact Clinical Trial Enrollment Due to Increased Exposure to the Virus

January 4, 2021
Darlene Dobkowski, MA

In participants who reported that the pandemic negatively impacted their decision to enroll in a clinical trial, some of the most common reasons included exposure to the virus and limited access to care.

Nearly one in five patients with cancer reported that they were less likely to enroll in a clinical trial due to fears of COVID-19 exposure, according to a research letter published in JAMA Oncology.

“While most patients would still be willing to take part in a clinical trial during the pandemic, the fear of COVID-19 exposure that would come with participating in a clinical trial is poised to cause many otherwise interested patients from enrolling,” said Mark Fleury, principal of policy development and emerging science at the American Cancer Society Cancer Action Network, said in a press release from the organization. “This means that trials that already struggled to find enough patients are likely to see reduced enrollment as long as the pandemic continues. The barriers patients already faced pre-pandemic made it challenging to take part in clinical trials. Now, with the addition of COVID-19, it is even harder, and we’re likely to see long-term impacts on the pace of research.”

Researchers integrated questions related to COVID-19 into a survey distributed to the American Cancer Society Cancer Action Network’s Survivor Views panel, which consisted of participants who were diagnosed with and/or treated for cancer in the last five years. In particular, the COVID-19 specific questions addressed a participant’s willingness to participate in trials, their disposition towards them and potential reasons for not participating. Of the 3,054 participants who received this survey, 933 participants, or 30.6% of survey recipients (73.1% women; 3.6% Black; 36.6% with an annual household income less than $60,000), submitted responses that were included in this study.

In participants who responded to the survey, 33.9% reported previously speaking with their physician about clinical trial participation. In addition, 20.6% were offered an opportunity to participate in a trial, of whom 78.1% said yes and 60.4% eventually enrolled in a trial. This resulted in an overall participation rate of 12.4%. In 662 participants who were not offered to participate in a trial, 78.4% reported that they either very likely or somewhat likely to enroll if they were offered the opportunity.

The survey also asked participants if the COVID-19 pandemic impacted their decision to participate in a clinical trial. Of 907 participants, 79.5% reported that the pandemic did not make a difference. The remaining participants in this group were more than seven times as likely to report that the pandemic negatively impacted their decision to participate in a trial. These response patterns were similar across socioeconomic, demographic and care settings.

In the 164 participants who were less likely to enroll in a trial during the pandemic, the most common reasons were difficultly in accessing care during the pandemic (18.3%) and fear of the increased exposure to COVID-19 (70.1%).

“The National Cancer Institute and the U.S. Food and Drug Administration have provided guidance on increasing flexibility for trial investigators during the COVID-19 pandemic,” the study authors wrote. “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.”

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