Browsing by Author "Mitsudomi, Tetsuya"

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    International Association for the Study of Lung Cancer Study of the Impact of Coronavirus Disease 2019 on International Lung Cancer Clinical Trials
    (ELSEVIER SCIENCE INC, 2022-01-01) Smeltzer, Matthew P.; Scagliotti V, Giorgio; Wakelee, Heather A.; Mitsudomi, Tetsuya; Roy, Upal Basu; Clark, Russell C.; Arndt, Renee; Pruett, Clayton D.; Kelly, Karen L.; Ujhazy, Peter; Johnson, Melissa L.; Eralp, Yesim; Barrios, Carlos H.; Barlesi, Fabrice; Hirsch, Fred R.; Bunn, Paul A.; Coronavi, Int Assoc Study Lung Canc; Comm, Clinical Trials Steering
    Introduction: To evaluate the effects of the global coronavirus disease 2019 (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 to 2020. A 64-question Action Survey evaluated 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 to June where we found significant decreases in individual site enrollment (p = 0.0309). Enrollment was not significantly different in October 2019 to December of 2019 versus 2020 (p = 0.25). The most frequent challenges identified by the Action Survey (N = 172) 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 the site (59\%). The most frequent mitigation strategies included modified monitoring requirements (47\%), telehealth visits (45\%), modified required visits (25\%), mailorder medications (25\%), and laboratory (27\%) and radiology (21\%) tests at nonstudy facilities. Sites that felt the most effective mitigation strategies were telehealth visits (85\%), remote patient-reported symptom collection (85\%), off-site procedures (85\%), and remote consenting (89\%).Conclusions: The COVID-19 pandemic created many challenges for lung cancer clinical trials conduct and enrollment. Mitigation strategies were used and, although the pandemic worsened, trial enrollment improved. A more flexible approach may improve enrollment and access to clinical trials, even beyond the pandemic.(c) 2022 Published by Elsevier Inc. on behalf of International Association for the Study of Lung Cancer.