The impact of COVID-19 on international lung cancer clinical trials

In 2020, the global COVID-19 pandemic created major barriers to enrolment and completion of clinical trials. The International Association for the Study of Lung Cancer (IASLC) therefore performed a global clinical trial survey to evaluate aggregate monthly enrolment for lung cancer trials. In addition, a 64-question Action Survey identified the most frequently reported challenges and mitigation strategies that were used to combat these impacts.

The COVID-19 pandemic created major barriers to enrolment and completion of clinical trials. To better understand the impact of COVID-19 on lung cancer clinical trials, the International Association for the Study of Lung Cancer (IASLC) surveyed investigators and collected enrolment data for worldwide lung cancer trials before (2019) and during (2020-2021) the pandemic. Therefore, a Data Collection Survey evaluated aggregate monthly enrolment for international lung cancer trials from 2019-2020, while an Action Survey assessed the impact of COVID-19 on the conduct of clinical trials and identified mitigation strategies used. For the latter, a 64-question action survey was distributed by email to select international clinical trial sites. Action survey responses were received from 173 clinical sites across 45 countries, collecting data from 171 trials.

Study results

Clinical trial enrolment declined by 43% from 2019 to 2020 (IRR: 0.57 [CI: 0.37-0.88], p= 0.0115), with the most dramatic decrease in April-August. Although monthly COVID-19 cases increased consistently for all of 2020, the impact on trial enrolment was significantly less in October-December compared to April-June of 2020 (p= 0.0160). The most frequent challenges identified by the Action Survey (N=173) were fewer eligible patients (67%), protocol compliance (61%), suspension of trials (60%), research staff availability (48%), and institutional closures (39%). Overall 26% of sites reported disruptions from trial participants due to a COVID-19 infection and 40% from exposure-related quarantine. Other patient-specific challenges included their willingness to visit the site (63%), their ability to travel (60%) and the access to the trial site (52%). Patients were mostly concerned about the fear of a COVID-19 infection (83%), travel restrictions (47%), securing transportation (38%) and the access to the laboratory or radiology department (14%).

The Action Survey also identified the most frequent mitigation strategies that were employed by the different study sites. These 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%). With this, more flexibility in ‘place’ and ‘time’ was obtained.

Conclusion

The COVID-19 pandemic created many challenges causing reductions in lung cancer clinical trial enrolment. Although the pandemic worsened, trial enrolment began to improve due, at last in part, to the mitigation strategies that were employed to remove these barriers. Nonetheless, more flexible approaches should be approved by sponsors, trial sites and global regulatory bodies. These should at least allow for telehealth visits, allowing local testing including labs and scans, mailing experimental agents where possible and flexible alterations in trial schedules. Overall, a more flexible approach may improve enrolment and access to clinical trials, even beyond the pandemic.

Reference

Smeltzer MP, Bunn PA, Clark R, et al. International Association for the Study of Lung Cancer (IASLC) Study of the Impacts of COVID-19 on International Lung Cancer Clinical Trials. Presented at the 2021 World Conference on Lung Cancer; Abstract PL02.09.