Study Finds Decline in Global Lung Cancer Clinical Trial Enrollment During COVID-19

Researchers analyzed declines in clinical trial enrollment and asked sites what mitigation strategies they employed to meet the reduction.

Throughout the COVID-19 pandemic, enrollment in lung cancer clinical trials fell by 14% globally, according to new research published in the Journal of Thoracic Oncology.

As it accounts for over 1.8 million deaths annually, lung cancer serves as the leading cause of cancer-related death, researchers explained, and during the COVID-19 pandemic, this patient population faced unique challenges.

For example, an individual with lung cancer infected with COVID-19 has an increased risk of severe disease and mortality, while for those who did not contract COVID-19, shutdowns have resulted in delays in diagnostic procedures and continuation of treatment.

Although advances in early detection and use of targeted therapies increase survival in those with lung cancer, these strategies were developed based on clinical trial findings. Of note, less than 5% of patients with lung cancer participate in clinical trials, with rates varying based on demographic factors.

To better understand the impact of COVID-19 on enrollment in lung cancer clinical trials, the International Association for the Study of Lung Cancer (IASLC) assessed enrollment data and conducted a word-wide survey.

An ad hoc committee met 2 to 4 times per month between September 2020 and March 2021 to identify global leaders and sites conducting lung cancer trials and to formulate surveys on identifying mitigation strategies, authors explained.

Enrollment figures for each month of 2020 were compared with control figures from 2019, while all lung cancer trials open to enrollment in 2019 or 2020 were included in the analysis.

Study enrollment data from 294 trials across 26 countries were evaluated, with most trials taking place in North America (n = 114). Fifty-five trials took place in Asia, 26 in Latin America, 79 in Europe, and 20 in the rest of the world.

Of the 294 trials, 4163 patients were enrolled in 2019 compared with 3590 in 2020, marking a 14% decline. A total of 173 survey responses were assessed.

Researchers found:

  • Most reductions in enrollment occurred in April-June where there were significant decreases in individual site enrollment (P = .0309); enrollment was not significantly different in October-December of 2019 versus 2020 (P = .25)
  • The most frequent challenges for enrollment 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 site (59%)

With regard to mitigation strategies, survey responses revealed modified monitoring requirements, telehealth visits, and modified required visits were the most frequently reported solutions (47%, 45%, and 25%, respectively). Completing mail-order medications and laboratory and radiology visits at non-study facilities were also identified as mitigation strategies.

In addition, “sites felt the most effective mitigation strategies were telehealth visits (85%), remote patient reported symptom collection (85%), off-site procedures (85%), and remote consenting (89%),” authors wrote.

Differences in trial enrollment varied across regions between 2019 and 2020, with a 13% decrease reported in North America compared with an 88% decrease in Latin America.

Nearly a quarter of sites reported trial participation disruption due to a COVID-19 infection while 40% experienced disruptions from exposure-related quarantine. Chemotherapy, immunotherapy, and targeted therapy trials reported moderate or greater impacts most frequently.

“Patient concerns included fear of COVID-19 infection (83%), securing transportation (38%), travel restrictions (50%), and lab/radiology access (16%),” said corresponding author Matthew Smeltzer, PhD, of the University of Memphis in Tennessee.

Overall, allocation of health resources toward caring for COVID-19 patients made allocation of time and resources for clinical trial monitoring less feasible. In the future, increased integration of electronic medical records and electronic data collection can help streamline cancer trials and improve flexibility, researchers concluded.

“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,” Smeltzer said.

Reference

Smeltzer MP, Scagliotti GV, Wakelee HA, et al. International association for the study of lung cancer (IASLC) study of the impact of COVID-19 on international lung cancer clinical trials. J Thorac Oncol. Published online February 17, 2022. doi:10.1016/j.jtho.2022.01.017