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. 2022 May;17(5):651-660.
doi: 10.1016/j.jtho.2022.01.017. Epub 2022 Feb 17.

International Association for the Study of Lung Cancer Study of the Impact of Coronavirus Disease 2019 on International Lung Cancer Clinical Trials

Matthew P Smeltzer  1 , Giorgio V Scagliotti  2 , Heather A Wakelee  3 , Tetsuya Mitsudomi  4 , Upal Basu Roy  5 , Russell C Clark  6 , Renee Arndt  6 , Clayton D Pruett  6 , Karen L Kelly  7 , Peter Ujhazy  8 , Melissa L Johnson  9 , Yesim Eralp  10 , Carlos H Barrios  11 , Fabrice Barlesi  12 , Fred R Hirsch  13 , Paul A Bunn  14 ; International Association for the Study of Lung Cancer Coronavirus Disease 2019 and Clinical Trials Steering Committee
Affiliations

International Association for the Study of Lung Cancer Study of the Impact of Coronavirus Disease 2019 on International Lung Cancer Clinical Trials

Matthew P Smeltzer et al. J Thorac Oncol. 2022 May.

Abstract

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%), mail-order 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.

Keywords: COVID-19; Clinical trials; Lung cancer; Telehealth.

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Figures

Figure 1
Figure 1
(A) The average enrollment in global clinical trials by month for 2019 (the year before the pandemic) and 2020 (the first year of the pandemic). The dotted line reveals the monthly COVID-19 cases diagnosed globally for each month of 2020. (B) Total numbers of patients enrolled in global clinical trials by month for 2019 (the year before the pandemic) and 2020 (the first year of the pandemic). (C) Quarterly enrollment per site for 240 individual sites included in this study, compared between 2019 and 2020. (D) Quarterly enrollment per site for 54 multiple sites included in this study, compared between 2019 and 2020. Apr, April; Aug, August; Avg., Average; COVID-19, coronavirus disease 2019; Dec, December; Feb, February; Jan, January; Jul, July; Jun, June; Mar, March; Mov., moving; Nov, November; Oct, October; Sep, September.
Figure 2
Figure 2
Site reported challenges to enrollment in lung cancer clinical trials by perceived severity.
Figure 3
Figure 3
Site reported mitigation strategies to address challenges to enrollment in lung cancer clinical trials.
Figure 4
Figure 4
Mitigation strategies sites identified as the most effective. IRB, Institutional Review Board.
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