Original Article
COVID Collection
International Association for the Study of Lung Cancer Study of the Impact of Coronavirus Disease 2019 on International Lung Cancer Clinical Trials

https://doi.org/10.1016/j.jtho.2022.01.017Get rights and content
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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

Clinical trials
COVID-19
Lung cancer
Telehealth

Cited by (0)

Disclosure: The International Association for the Study of Lung Cancer received funding for this project from Amgen, AstraZeneca, Daiichi Sankyo, Foundation Medicine, Novartis, and Regeneron. Dr. Bunn has received consulting income from AstraZeneca, Ascentage, Bristol-Myers Squibb, C-Stone, Imidex, Merck, and Verastem not related to this project. Dr. Smeltzer has worked as a paid research consultant for the Association of Community Cancer Centers. Dr. Scagliotti received honoraria from AstraZeneca, Eli Lilly, Merck Sharp & Dohme, Pfizer, Roche, Johnson & Johnson, and Takeda; consulting or advisory role for Eli Lilly, Beigene, and AstraZeneca; received institutional research funding from Eli Lilly and Merck Sharp & Dohme; and received travel, accommodations from Bayer, all not related to the current project. Dr. Roy received institutional research funding from AstraZeneca, Eli Lilly, Merck, Blueprint Medicine, Genentech, G1 Therapeutics, Takeda, Bristol-Myers Squibb, and Janssen not related to the current project. Dr. Barlesi received honoraria from AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly Oncology, F. Hoffmann–La Roche Ltd., Novartis, Merck, Mirati, Merck Sharp & Dohme, Pierre Fabre, Pfizer, Seattle Genetics, and Takeda. Dr. Kelly has received honoraria from AbbVie, Amgen, AstraZeneca, Debiopharm, Daiichi Sankyo, EMD Serono, Genentech, Genmab, Janssen, Novartis, Regeneron, and Sanofi/Genzyme. Dr. Mitsudomi received advisory/lecture fees from AstraZeneca, Novartis, Chugai, Boehringer Ingelheim, Pfizer, Roche, Merck Sharp & Dohme, Thermo Fisher, Roche Diagnostics, Bristol-Myers Squibb, Ono Pharmaceuticals, Taiho, Takeda, Amgen, Johnson and Johnson, Janssen Pharma, Puma, Beigene, Bridge Biotherapeutics, Eli Lilly, Daiichi Sankyo, and Thermo Fisher and research funding from AstraZeneca, Chugai, Boehringer Ingelheim, Pfizer, Taiho, Ono, Merck Sharp & Dohme, Daiichi Sankyo, Eli Lilly, Ethicon, and Bridge Biotherapeutics. Dr. Johnson received institutional research funding from AbbVie, Acerta, Adaptimmune, Amgen, Apexigen, Arcus Biosciences, Array BioPharma, Artios Pharma, AstraZeneca, Atreca, BeiGene, BerGenBio, Boehringer Ingelheim, Calithera Biosciences, Checkpoint Therapeutics, Corvus Pharmaceuticals, Curis, CytomX, Daiichi Sankyo, Dracen Pharmaceuticals, Dynavax, Eli Lilly, EMD Serono, Genentech/Roche, Genmab, Genocea Biosciences, GlaxoSmithKline, Gritstone Oncology, Guardant Health, Harpoon, Hengrui Therapeutics, Immunocore, Incyte, Janssen, Jounce Therapeutics, Kadmon Pharmaceuticals, Loxo Oncology, Lycera, Merck, Mirati Therapeutics, Neovia Oncology, Novartis, OncoMed Pharmaceuticals, Pfizer, PMV Pharmaceuticals, Regeneron Pharmaceuticals, Ribon Therapeutics, Rubius Therapeutics, Sanofi, Seven and Eight Biopharmaceuticals/Birdie Biopharmaceuticals, Shattuck Labs, Silicon Therapeutics, Stem CentRx, Syndax Pharmaceuticals, Takeda Pharmaceuticals, Tarveda, TCR2 Therapeutics, TMUNITY Therapeutics, University of Michigan, and WindMIL; consulting or advisory role for AbbVie, Achilles Therapeutics, Amgen, AstraZeneca, Atreca, Boehringer Ingelheim, Bristol-Myers Squibb, Calithera Biosciences, Checkpoint Therapeutics, CytomX Therapeutics, Daiichi Sankyo, Editas Medicine, Eisai, EMD Serono, G1 Therapeutics, Genentech/Roche, GlaxoSmithKline, Gritstone Oncology, Guardant Health, Ideaya Biosciences, Incyte, Janssen, Eli Lilly, Loxo Oncology, Merck, Mirati Therapeutics, Novartis, Pfizer, Ribon Therapeutics, Sanofi, Association of Community Cancer Centers, and WindMIL. The remaining authors declare no conflict of interest.