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

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.

"Most of that patient reticence is driven by fear of contracting the coronavirus, so the takeaway is that it will not be enough to simply reopen clinical research sites," said Mark Fleury, principal of policy development and emerging science at the American Cancer Society Cancer Action Network, in an interview with CURE®. "We need to also take concrete steps to address patient concerns or we will not see enrollment return to pre-pandemic levels until the virus is contained."

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.

"We immediately recognized that the pandemic could create entirely new barriers to trial enrollment that could cause long-lasting effects on the pace of innovative research," said Fleury. "In order to quickly address new COVID-related trial enrollment barriers, we had to understand them better, and that is where our survey came in."

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%).

"During the pandemic, the National Cancer Institute and the U.S. Food and Drug Administration have both issued directives that allow considerable new flexibilities in the conduct of clinical trials in an attempt to reduce patient exposure to the novel coronavirus," said Fleury. "These flexibilities include allowing remote informed consent, telemedicine check-ins for appointments that don't require interventions, shipping drugs to a patient's home and possibly allowing local providers to conduct some of the routine care portions of the trial protocol. These are exactly the types of steps that will be necessary to address patient concerns, and many trial sponsors and research sites have quickly taken advantage of these new trial modalities."

Fleury also provided some advice for patients who are hesitant about participating in clinical trials during the COVID-19 pandemic. He said, "A decision about clinical trial participation is intensely personal, so I'd advise a patient to consider their unique situation and the design of any potential clinical trial, and have a discussion with their provider and their family. The types of things I'd suggest considering include the local prevalence of COVID-19, their underlying health, the severity of their cancer, the available treatment options and where and how often they would go in for treatment on the trial, and how that might compare to non-trial care."

He added that patients should use their best judgement when making this decision. Fleury said, "In the end, if you are interested in a trial and feel that you can be a part of it without exposing yourself to additional risks, I would do it. If there are aspects of the trial that give you concern, ask the research staff if something can be done, like substituting some telemedicine visits for in-person ones."

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