LAUSR

Introduction To determine the effects of the global COVID-19 pandemic on lung cancer trials, we surveyed investigators and collected aggregate enrollment data for lung cancer trials across the world before and during the pandemic. Methods A Data Collection Survey collected aggregate monthly enrollment numbers from 294 global lung cancer trials for 2019-2020. A 64-question Action Survey assessed the impact of COVID-19 on clinical trials and identified mitigation strategies implemented. Results Clinical trial enrollment declined from 2019 to 2020 by 14% globally. Most reductions in enrollment occurred in April-June where we found significant decreases in individual site enrollment (p=0.0309). Enrollment was not significantly different in October-December of 2019 versus 2020 (p=0.25). The most frequent challenges identified by the Action Survey (N=173) were fewer eligible patients (63%), decrease in protocol compliance (56%), and suspension of trials (54%). Patient-specific challenges included access to trial site (49%), ability to travel (54%), and willingness to visit site (59%). The most frequent mitigation strategies included modified monitoring requirements (47%), telehealth visits (45%), modified required visits (25%), mail-order medications (25%), and laboratory (27%) and radiology (21%) tests at non-study facilities. Sites felt the most effective mitigation strategies were telehealth visits (85%), remote patient reported symptom collection (85%), off-site procedures (85%), and remote consenting (89%). Conclusion The COVID-19 pandemic created many challenges for lung cancer clinical trials conduct and enrollment. Mitigation strategies were employed and, although the pandemic worsened, trial enrollment improved. A more flexible approach may improve enrollment and access to clinical trials, even beyond the pandemic.