Flexibility positively impacts lung cancer clinical trial participation in COVID-19 era
medwireNews: Strategies to improve flexibility in clinical trials may improve enrollment rates during and after the COVID-19 pandemic, according to a study presented at the IASLC 2021 World Conference on Lung Cancer.
The two-part study by the IASLC involved the collection of aggregate enrollment data for lung cancer clinical trials before and during the pandemic, as well as a survey of investigators from 171 trials across 45 countries, explained presenting author Matthew Smeltzer (University of Memphis, Tennessee, USA).
Overall, enrollment to lung cancer clinical trials fell by 43% in 2020 compared with the prior year, “with the most dramatic decrease” observed between April and August, according to Smeltzer.
The survey revealed that the most common institutional challenges to enrollment were fewer eligible patients, difficulties complying with protocols, suspension of trials, research staff availability, and institutional closures, cited by a respective 67%, 61%, 60%, 48%, and 39% of survey respondents.
Patient-specific challenges and concerns included fear of COVID-19 infection (according to 83% of respondents), willingness to visit (63%), ability to travel to (60%), and access to (52%) the site, and travel restrictions (47%).
Mitigation strategies were employed to improve enrollment, of which the most common were modified monitoring requirements, telehealth visits, and labs at non-study facilities, as highlighted by 44%, 43%, and 27%, of respondents, respectively.
The most effective strategies were considered to be those that allowed “flexibility in place,” such as remote monitoring (by 64% of respondents) and diagnostics (59%), telehealth visits (59%), and modified symptom monitoring, and those that enabled “flexibility in time,” namely delayed visits (65%), delayed assessments (62%), and institutional review board changes (62%), highlighted Smeltzer.
He also noted that by October–December 2020 enrollment had improved “despite a marked increase in COVID-19 cases per month across the world,” an improvement that Smeltzer believes is “due in part” to the implementation of these mitigation strategies.
And he concluded: “A more flexible approach – removing unnecessary barriers – may improve enrollment and access to clinical trials, even beyond the pandemic.”
Marina Garassino, from the University of Chicago in Illinois, USA, who discussed the presentation only “partially agrees” with the study conclusions.
She pointed out that although “the mitigation strategies were fundamental,” enrollment “was still very low” in December and suggested that the strategies are able to remove some, but not all of the barriers.
Nevertheless, Garassino believes that “a more flexible approach is very important to continue research in the future.”
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group
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