COVID-19 Pandemic Causes Apprehension for Trial Enrollment Among Patients With Cancer

Mark Fleury, PhD

The majority of respondents in a survey study indicated that the COVID-19 pandemic made no difference in their decision to participate in an oncology clinical trial; however, 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, according to a research letter published in JAMA Oncology.

Among 907 responders, 79.5% (n = 721) said that the pandemic did not influence whether they were more or less likely to participate in a clinical trial. Of the remaining responders, 18.1% (n = 164) cited the COVID-19 pandemic as a reason that they were less likely to enroll onto a trial. Notably, 2.4% (n = 22) of responders were more likely to participate in a trial despite the pandemic.

“With the onset of the COVID-19 pandemic, many sites shut down what they considered non-essential visits to try to avoid transmission of COVID-19,” said lead author Mark Fleury, PhD, principal of policy development at the American Cancer Society Cancer Action Network. “As a result, many clinical trials stopped accruing patients and/or stopped seeing patients who were already accrued onto a clinical trial”.

As the spread of COVID-19 continued, it was important to understand whether patients cited the transmission of COVID-19 as a reason not to enroll onto clinical trials, explained Fleury.

As such, the survey study was made up of responses from the American Cancer Society Cancer Action Network’s Survivor Views panel, which was established in September 2019. All participants were 18 years or older, residents of the United States, and had been diagnosed with and/or treated for cancer within the past 5 years. Notably, patients on active treatment were included, Fleury said.

Of the respondents with known data (n = 933), 73.1% (n = 675 of 924) were female, and 1 (of 924) patient indicated that they were transgender. Additionally, 68.0% (626 of 920) were younger than 65. Subgroup examinations by race were not indicated because of the small sample size; however, non-White participants included individuals who self-reported as Black (n = 33), Asian/Pacific Islander (n = 19), and Native American (n = 14).

Additionally, 147 participants preferred not to answer the question regarding their household income and 36.6% (n = 284 of 924) reported having an annual household income of $60,000 or less.

Unknown patient data included age (n = 13), race (n = 13), household income (n = 9), gender (n = 9), and care setting (n = 5).

Most patients (69.1%) had 1 of the 4 most common tumor types, including breast cancer (45.9%), colorectal cancer (7.4%), lung cancer (7.7%), or prostate cancer (8.1%).

Additionally, 33.9% (n = 316 of 933) of participants reported having a prior conversation with their physician regarding clinical trials and 20.6% (n = 192 of 933) were offered participation in a trial. Of those offered a trial, 78.1% (n = 150) said yes and 60.4% (n = 116) eventually enrolled, translating to a 12.4% overall participation rate. Finally, of those respondents who were not offered a trial, the majority (n = 519; 78.4%) said that they were somewhat or very likely to enroll if they were offered enrollment onto a study.

All participants were asked to answer a series of questions to gauge their disposition toward clinical trials, their willingness to participate in trials, and reasons for non-participation given the COVID-19 pandemic. In total, the survey was sent to 3054 members of the panel on May 27, 2020 through June 17, 2020.

The survey was exempt by the Morehouse School of Medicine Institutional Review Board and patient-informed consent was required of all study participants.

Further analysis of the survey findings showed that response patterns were similar irrespective of demographic status, socioeconomic status, care setting (rural, suburban, or urban), and whether participants previously agreed to participate in a clinical trial.

Of those who said they were less likely to enroll on a clinical trial, the most common reason reported by 70.1% (n = 115) of respondents was fear of exposure to COVID-19. Other reasons for the reduced likelihood of enrollment were trouble accessing normal care, not wanting to be further away from home or family, financial hardship from the COVID-19 pandemic, and other.

“We were entering this whole new world when it came to conducting clinical trials during a pandemic and we didn’t understand how that dynamic between patients and non-patient barriers [to clinical trial enrollment] might be altered,” said Fleury. “How do we address [the fear participants have contracting COVID-19]? We recommended that sites employ techniques and technologies to try to reduce the risk of transmission. We know that normal care, as well as clinical trials, have shifted to telemedicine visits where possible.”

For example, in the pre-pandemic era, patients had to come into the clinic to sign the document stating they were consenting to enroll onto a clinical trial. Now, signing can be done remotely during a virtual visit, explained Fleury.

It is likely that once the number of cases of COVID-19 begin to decrease, patient reluctance to enroll in trials will as well, Fleury said. However, technologies, such as telemedicine, will likely remain key elements of a post-pandemic health care system.

Moreover, it is critical to take the “glass-half-full” approach because the majority of patients did not report that COVID-19 influenced their willingness to enroll on a clinical trial, Fleury said.

“Almost 80% of patients were equally likely to enroll [onto a clinical trial], so we know that the structural barriers outside of [patients] control…are likely to continue to be the overwhelming barrier that patients face. I want to focus on the good news that patients were more than willing to enroll before the pandemic, and during the pandemic they were largely still willing to enroll,” concluded Fleury.

Reference

Fleury ME, Farner AM, Unger JM. Association of the COVID-19 outbreak with patient willingness to enroll in cancer clinical trials. JAMA Oncol. 2021;7(1):131-132. doi:10.1001/jamaoncol.2020.5748