Enrollment in lung cancer clinical trials declined by 43% during the COVID-19 pandemic, according to research presented by Smeltzer et al at the International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung Cancer (Abstract PL02.09).
To assess the impact COVID-19 had on 171 lung cancer clinical trials, IASLC collected monthly enrollment data and issued a 64-question survey to international clinical trial sites, which included government and regulatory agencies, industry sponsors, and investigators from 45 countries.
“Clinical trial enrollment declined by 43% from 2019 to 2020, with the most dramatic decrease in April to August of 2020,” reported Matthew Smeltzer, PhD, of the University of Memphis. “Although monthly COVID-19 cases increased consistently for all of 2020, trial sites implemented mitigation strategies, and the impact of COVID-19 on trial enrollment was significantly less in October to December compared with April to June of 2020.”
Issues in Trials During the Pandemic
The most frequent challenges identified by clinical trials sites surveyed were fewer eligible patients (67%), suspension of trials (60%), institutional closures (39%), research staff availability (48%), and protocol compliance (61%). Overall, 26% of sites reported disruptions from trial participants due to COVID-19 infection and 40% due to exposure-related quarantine. Clinical trial investigators also mentioned patient-specific challenges, which included access to the trial site (52%), ability to travel (60%), and willingness to visit the trial site (63%).
“Patient concerns included fear of COVID-19 infection (83%), securing transportation (38%), travel restrictions (47%), and lab/radiology access (14%),” added Dr. Smeltzer.
To respond to these barriers, researchers used several strategies, including modified monitoring requirements (44%), telehealth visits (43%), modified required visits (25%), mail-order medications (24%), and altered trial schedules (19%). Additionally, some sites allowed labs (27%) and radiology (20%) at non-study facilities, and a few implemented altered (7%) or electronic (10%) consent processes.
Many of those surveyed reported that they believed the most effective mitigation strategies were delayed visits (65%), remote monitoring (64%), delayed assessment (62%), Institutional Review Board changes (62%), remote symptom monitoring (59%) or diagnostics (59%), and telehealth visits (59%).
“The COVID-19 pandemic created many challenges causing reductions in lung cancer clinical trial enrollment. Mitigation strategies were employed, and even though the pandemic worsened, trial enrollment began to improve. A more flexible approach removing unnecessary barriers may improve enrollment and access to clinical trials, even beyond the pandemic,” Dr. Smeltzer concluded.
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