Patients with Cancer Less Likely to Enroll in Clinical Trials Due to COVID-19

A research letter published in JAMA Oncology suggested that as long as high rates of coronavirus disease 2019 (COVID-19) cases exist, patients with cancer will be less likely to consider trial participation even when sites return to what they were before the pandemic.¹

According to a survey conducted by the investigators, nearly 1 in 5 patients with cancer reported that the pandemic would make them less likely to enroll in a clinical trial. The top reason provided for not enrolling was fear of COVID-19 exposure.

"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. This means that trials that already struggled to find enough patients are likely to see reduced enrollment as long as the pandemic continues," co-author of the article Mark E. Fleury, PhD, policy principle for emerging issues at the American Cancer Society Cancer Action Network (ACS CAN), said in a press release.² "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."

The survey participants were included from the ACS CAN Survivor Views panel, established in September 2019. Respondents were 18 years or older, had been diagnosed with and/or treated for cancer within the last 5 years, and were US residents.

Participants were asked a series of COVID-19 related questions regarding disposition toward trials, willingness to participate, and reasons for not participating in addition to the questions already provided in the existing survey program. The survey was sent to a total of 3054 individuals on May 27, 2020, through June 17, 2020; 933 responses (30.6%) were received.

Of the 933 respondents, 675 (73.1%) were female, 33 (3.6%) self-reported as Black, and 284 (36.6%) had an annual household income of $60,000 or less. Among the total cohort, 316 (33.9%) respondents reported a prior conversation with their physician about clinical trials, and 192 (20.6%) were offered trial participation.

Of the 192 respondents offered a trial, 150 (78.1%) indicated they said yes and 116 (60.4%) reported they eventually enrolled, resulting in an overall participation rate of 12.4%. Moreover, of the 662 respondents not offered trial participation, 519 (78.4%) reported being somewhat or very likely to enroll if offered a trial.

All survey respondents were asked if the pandemic made them more or less likely to participate in a clinical trial, or if it made no difference. Among 907 respondents, the majority (79.5%) indicated the pandemic made no difference. The remaining respondents were more than 7 times more likely to indicate that the pandemic made them less likely to enroll in a clinical trial (18.1% vs 2.4%).

"The pandemic caused many institutions to stop enrolling new patients on clinical trials, and the assumption was that once facilities reopened, they could get enrollment back to normal. What we've found is that so long as the pandemic is still underway, fewer patients are going to volunteer for clinical trials," said Fleury. "The solution is that we need to get the pandemic under control or find innovative ways like telemedicine visits so that patients can take part in clinical trials without feeling exposed to additional COVID-19 risks."

Of note, response patterns were found to be similar across demographic, socioeconomic, and care settings, as well as in the subset of 150 participants who previously agreed to trial participation. Among the 164 respondents less likely to enroll, the most common reasons provided were fear of increased COVID-19 exposure (70.1%) or difficulty accessing care during the pandemic (18.3%).

“The National Cancer Institute and the US Food and Drug Administration have provided guidance on increasing flexibility for trial investigators during the COVID-19 pandemic,” the authors of the article concluded. “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.”

References:

1. Fleury ME, Farner AM, Unger JM. Association of the COVID-19 Outbreak With Patient Willingness to Enroll in Cancer Clinical Trials. JAMA Oncology. doi: 10.1001/jamaoncol.2020.5748

2. Nearly 1 in 5 cancer patients less likely to enroll in clinical trials during pandemic [news release]. Washington, DC. Published November 12, 2020. Accessed November 13, 2020. https://www.eurekalert.org/pub_releases/2020-11/acs-n1i111120.php