Matthew Smeltzer, Ph.D., MStat, Associate Professor, Division of Epidemiology, Biostatistics, and Environmental Health at the University of Memphis. Dr. Smeltzer and his co-authors Scagliotti Giorgio, Heather Wakelee, Tetsuya Mitsudomi, and Fred R. Hirsch worked on this trial.  In this video, he speaks about the International Association for the Study of Lung Cancer (IASLC) Study of the Impact of COVID-19 on International Lung Cancer Clinical Trials.

Outline

Overview:

We polled investigators and collected aggregate enrollment data for lung cancer trials around the world before and during the worldwide COVID-19 pandemic to investigate the effects on lung cancer trials.

Methodologies:

For 2019-2020, a Data Collection Survey gathered aggregate monthly enrollment figures from 294 global lung cancer trials. A 64-question Action Survey was conducted to assess the impact of COVID-19 on clinical trials and to identify mitigating mechanisms that had been applied.

Outcomes:

Clinical trial enrollment fell by 14% globally between 2019 and 2020. The majority of enrollment drops occurred between April and June when we discovered substantial decreases in individual site enrollment (p=0.0309). Enrollment did not differ substantially between October and December of 2019 and October and December of 2020 (p=0.25). The most frequently highlighted problems by the Action Survey (N=173) were fewer eligible patients (63 percent), a decline in protocol compliance (56 percent), and trial suspension (54 percent ). Access to the trial site (49%) was cited as a patient-specific challenge, as was the ability to travel (54%) and willingness to visit the site (59 percent ). Modified monitoring requirements (47 percent), telehealth visits (45 percent), modified necessary visits (25 percent), mail-order drugs (25 percent), laboratory (27 percent), and radiology (21 percent) testing at non-study facilities were the most frequently used mitigation techniques. Telehealth visits (85 percent), the remote patient-reported symptom collecting (85 percent), off-site operations (85 percent), and remote consenting were deemed the most successful mitigation techniques by sites (89 percent ).

Implication:

The COVID-19 pandemic posed numerous hurdles to the conduct and recruitment of lung cancer clinical trials. Mitigation methods were implemented, and despite the fact that the pandemic intensified, trial enrolment increased. Even after the epidemic, a more flexible approach may enhance enrollment and access to research studies.