Mitigation Strategies Improved Lung Cancer Clinical Trial Enrollment During the COVID-19 Pandemic

Although clinical trial enrollment declined among patients with lung cancer from 2019 to 2020 during the COVID-19 pandemic, mitigation strategies helped to improve enrollment.

During the COVID-19 pandemic from 2019 to 2020, a decline in clinical trial enrollment was observed among patients with lung cancer; however, mitigation strategies helped to improve enrollment numbers could aid clinical trial efforts beyond the pandemic, according to survey results conducted by the International Association for the Study of Lung Cancer (IASLC) published in the Journal of Thoracic Oncology.1

The investigators reported a 14% decrease in trial enrollment globally from 2019 (n = 4163) to 2020 (n = 3590), with the most significant reductions in individual site enrollment occurring from April to June (P = .0309). Sites employed mitigation strategies to combat barriers to clinical trial enrollment. The strategies that sites implemented at least half, most, or all the time included modified monitoring requirements (47%), telehealth visits (45%), phone visits (42%), and mail-order medications (25%). In North America, Europe, and Asia, telehealth (38%-50%) and phone visits (39%-50%) were the most common mitigation strategies employed.

“Although monthly COVID-19 cases increased consistently for all of 2020, trial sites implemented mitigation strategies, and the impact of COVID-19 on trial enrollment was significantly less in October to December compared with April to June of 2020,” Matthew Smeltzer, PhD, an associate professor of the Division of Epidemiology Biostatistics and Environmental Health at the University of Memphis, said in a press release.2

The number of COVID-19 cases was estimated for each month in 2020, the data of which was downloaded from the IASLC’s Our World Data. Country data were categorized by IASLC region, specifically Asia, Europe, Latin America, North America, and the rest of the world.

The IALSC administered surveys to determine the impact of COVID-19 on lung cancer clinical trial enrollment, as well as the effectiveness of mitigation strategies that were employed to improve enrollment. The Action Survey included 64 questions targeting lung cancer clinical trial sites worldwide. A total of 429 sites were identified and contacted for survey responses.

Overall, enrollment data were analyzed from 294 lung cancer trials across 26 countries. Specifically, 114 trials took place in North America, 79 were in Europe, 55 were in Asia, 26 were in Latin America, and 20 were in the rest of the world.

Enrollment between 2019 and 2020 was also compared quarterly within single institutions and multiple institutions, with investigators reporting the highest enrollment reductions in quarter 2. This quarter showed significant reductions among single institutions and marginal reduction differences across multiple sites (P = .0541). Although enrollment was also lower in quarter 1 of 2019 compared with 2020 for single centers (P = .0185), quarter 4 enrollment saw no significant differences across years for single (P = .25) or multiple sites (P = .37).

When examining the data regionally, in 2019 compared with 2020, investigators observed a 35% decrease in total patients who enrolled on clinical trials in Europe, a 10% decrease in Asia, a 13% decrease in North America, an 88% decrease in Latin America, and a 5% increase in the rest of the world.

When asked by investigators, representatives from sites cited telehealth (85%), remote collection of patient-reported symptoms (85%), and off-site diagnostic or monitoring procedures (85%) as effective strategies.

“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 concluded.

References

  1. 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 15, 2022. doi:10.1016/j.jtho.2022.01.017
  2. COVID-19 pandemic significantly reduced lung cancer clinical trial enrollment. News release. International Association for the Study of Lung Cancer. February 17, 2022. Accessed Febraury 22, 2022. https://tinyurl.com/ycknuxzt