|The following article features coverage from the IASLC 2021 World Conference on Lung Cancer. Click here to read more of Cancer Therapy Advisor’s conference coverage.|
The COVID-19 pandemic led to a decrease in lung cancer trial enrollment but also prompted changes in trial conduct that helped enrollment bounce back, a global study suggests.
The study was presented at the IASLC 2021 World Conference on Lung Cancer (WCLC) by Matthew P. Smeltzer, PhD, of the University of Memphis in Tennessee.
Dr Smeltzer and colleagues surveyed trial investigators around the world to determine how COVID-19 has affected lung cancer trial enrollment and identify strategies investigators are using to reduce barriers to enrollment.
The 64-question survey was completed by investigators at 173 research sites representing 171 clinical trials in 45 countries.
Results showed that enrollment in lung cancer trials declined 43% from 2019 to 2020 (incidence rate ratio, 0.57; P =.0115).
The drop in enrollment was particularly acute between April and August 2020 but lessened between October and December 2020 (P =.016), despite a consistent increase in COVID-19 cases throughout 2020.
Survey respondents said their most common challenges related to trial enrollment were fewer eligible patients (67%), protocol compliance (61%), trial suspension (60%), research staff availability (48%), and institutional closures (39%).
The most common challenges for patients were unwillingness to visit the trial site (63%), inability to travel (60%), access to the trial site (52%), exposure-related quarantine (40%), and having COVID-19 (26%).
Most patients (83%) reported a fear of developing COVID-19. Other concerns included travel restrictions (47%), securing transportation (38%), and lab or radiology access (14%).
The most common strategies investigators used to reduce barriers to enrollment were modifying monitoring requirements (44%), telehealth visits (43%), using labs at non-study facilities (27%), modifying required visits (25%), sending medications via mail (24%), and using radiology at non-study facilities (20%).
Investigators identified the following strategies as the most effective ways to reduce barriers to enrollment: delaying visits (65%), remote monitoring (64%), delaying assessments (62%), institutional review board changes (62%), remote diagnostics (59%), telehealth visits (59%), and modified symptom monitoring (59%).
“In summary, a more flexible approach removing unnecessary barriers may improve enrollment and access to clinical trials, even beyond the pandemic,” Dr Smeltzer said.
Disclosures: This research was supported, in part, by Amgen, AstraZeneca, Daiichi Sankyo, Foundation Medicine, Novartis, and Regeneron. One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Smeltzer MP, Bunn PA, Clark R, et al. International Association for the Study of Lung Cancer (IASLC) study of the impacts of COVID-19 on international lung cancer clinical trials. Presented at: IASLC 2021 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer; September 8-14, 2021; Abstract PL02.09.