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International Association for the Study of Lung Cancer (IASLC) Study of the Impact of COVID-19 on International Lung Cancer Clinical Trials.

International Association for the Study of Lung Cancer (IASLC) Study of the Impact of COVID-19 on International Lung Cancer Clinical Trials. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer Smeltzer, M. P., Scagliotti, G. V., Wakelee, H. A., Mitsudomi, T., Roy, U. B., Clark, R. C., Arndt, R., Pruett, C. D., Kelly, K. L., Ujhazy, P., Johnson, M. L., Eralp, Y., Barrios, C. H., Barlesi, F., Hirsch, F. R., Bunn, P. A., IASLC COVID-19 and Clinical Trials Steering Committee 2022

Abstract

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.

View details for DOI 10.1016/j.jtho.2022.01.017

View details for PubMedID 35183774