PL02.09 International Association for the Study of Lung Cancer (IASLC) Study of the Impacts of COVID-19 on International Lung Cancer Clinical Trials

Abstract

In 2020, the global COVID-19 pandemic created major barriers to enrollment and completion of clinical trials. We surveyed investigators and collected aggregate enrollment data for lung cancer trials across the world before (2019) and during (2020-2021) the COVID-19 pandemic. This study consisted of two components. The 64-question Action Survey, distributed by email to select international clinical trial sites, assessed the impact of COVID-19 on the conduct of clinical trials at 173 sites in 2019-2021 and identified mitigation strategies used to combat these impacts. The Data Collection Survey collected aggregate enrollment numbers monthly from 171 lung cancer trials for 2019-2020. Data sources included government or regulatory agencies, industry sponsors, and Principal Investigators from 45 countries. We evaluated enrollment monthly and estimated Incidence Rate Ratios (IRR) with 95% confidence intervals (CI) by Generalized Estimating Equations. Aims of the study include: a) results from the Action Survey will be summarized to help understand the details of the impact COVID-19 had on clinical trials for lung cancer. We will report and evaluate mitigation strategies by region, economic status, trial type and COVID-19 burden; b) we will evaluate trial enrollment data from the Data Collection Survey over time by global region, trial type, and regional COVID-19 burden in simple analysis and with longitudinal statistical models; c) we will combine information from the Action Survey and Data Collection Survey to quantitatively evaluate the impact of mitigation strategies on clinical trial enrollment for trials open at the respective institutions. These results will be stratified by region, economic status, trial type, and regional COVID-19 burden. Additional analysis on how these strategies may impact patients will be included. Clinical trial enrollment declined by 43% from 2019 to 2020 (IRR: 0.57 [CI: 0.37, 0.88]) p=0.0115), with the most dramatic decrease April-August (Figure 1). Although monthly COVID-19 cases increased consistently for all of 2020, the impact on trial enrollment was significantly less in October-December compared to April-June of 2020 (p=0.0160, Figure 1). The most frequent challenges identified by the Action Survey (N=173) were fewer eligible patients (67%), suspension of trials (60%), institutional closures (39%), research staff availability (48%), and protocol compliance (61%). Overall 26% of sites reported disruptions from trial participants COVID-19 infection and 40% from exposure-related quarantine. Patient-specific challenges included access to trial site (52%), ability to travel (60%), and willingness to visit site (63%). Patient concerns included fear of COVID-19 infection (83%), securing transportation (38%), travel restrictions (47%), and lab/radiology access (14%). The Action Survey identified the most frequent mitigation strategies sites employed, which included modified monitoring requirements (44%), telehealth visits (43%), modified required visits (25%), mail-order medications (24%), and altered trial schedules (19%). Some sites allowed labs (27%) and radiology (20%) at non-study facilities and a few implemented altered (7%) or electronic (10%) consent processes. Sites felt the most effective mitigation strategies were delayed visits (65%), remote monitoring (64%), delayed assessment (62%), IRB changes (62%), remote symptom monitoring (59%) or diagnostics (59%), and telehealth visits (59%). The COVID-19 pandemic created many challenges causing reductions in lung cancer clinical trial enrollment. Mitigation strategies were employed and, even though the pandemic worsened, trial enrollment began to improve. A more flexible approach -removing unnecessary barriers- may improve enrollment and access to clinical trials, even beyond the pandemic.