COVID-19 Fears Affect Clinical Trial Enrollment

COVID-19 Fears Affect Clinical Trial Enrollment

As reported previously, clinical trial enrollments decreased in the midst of COVID-19, primarily due to concerns about contagion. To examine the attitudes of cancer survivors toward trial participation, Dr. Mark Fleury, et al surveyed a large group of patients from the American Cancer Society Cancer Action Network’s Survivor Views panel in mid-2020. The results of this analysis were published in a JAMA Research Letter in January 2021.

Dr. Fleury et al incorporated a series of COVID-19-related questions into the existing survey program, sent to 3054 participants between 27 May and 17 June 2020. They received 933 (31%) responses, 192 of whom had been offered trial participation by their physician. Of those, a majority (60%) later enrolled in clinical trials. Of those not offered trial participation, most said they would likely enroll if offered a trial. Conversely, nearly one-fifth of participants reported that the pandemic had made them less likely to enroll in a clinical trial, most commonly due to fear of increased COVID-19 exposure or difficulty accessing care during the pandemic. These responses were consistent across evaluable demographic/socioeconomic patient groups.

It is important to note that the survey was administered very early in the US epidemic. In a comment letter, Dr. Bayle, et al cautioned that this may have led to biased results. They suggested that patients with cancer often want to participate in a clinical trial because it is either their last or best option and that they may not want to miss out on the reopening of trials, regardless of local COVID-19 rates. Dr. Fleury and Dr. Unger addressed this by replying that half of the respondents were actively receiving treatment at the time of the survey, and half were within 5 years of diagnosis or treatment, thus countering potential bias.

High level
Given that the survey was conducted prior to vaccine availability in the US, it is possible that this trend may change in 2021 as COVID-19 cases are on the decline. However, in countries where COVID-19 is still prevalent, patients may have similar hesitancy to enroll in clinical trials. The National Cancer Institute and US Food and Drug Administration have provided guidance for trial investigators that focus on reducing COVID-19 exposure or offering alternative care settings. Trial sponsors are encouraged to take advantage of the approaches in these guidelines to help address patient concerns.

Ground level
Now that millions of people have been vaccinated, many researchers are hopeful that the trend will shift and clinical trial enrollment will increase. There are several factors that influence trial enrollment, but ultimately, a patient’s decision is the final determinant of whether they will join a trial. Therefore, alleviating patient barriers to trial participation may help increase enrollment. Offering opportunities for remote participation where possible and assuring patients that their care will not be disrupted can help address patient fears during the COVID-19 pandemic.