Serious adverse events (SAEs) were reported less frequently among patients enrolled in cancer trials during the first 2 years of the COVID-19 pandemic than among patients enrolled prior to the pandemic, according to a study published in JAMA Oncology.
This finding could not be explained by an increase in telehealth use during the pandemic, the researchers noted. The decrease in SAE reporting may have been related to staffing shortages, administrative burdens, and protocol changes, the researchers speculated.
The researchers conducted this retrospective study to evaluate reporting of SAEs among patients enrolled on investigator-initiated phase 1-3 oncology trials (not including trials of gynecologic cancers).
Continue Reading
The study included data from 530 patients enrolled on such trials for at least 14 days. About half of patients (45.7%) were enrolled in a trial prior to the pandemic (January
1, 2019, through March 14, 2020), and about half (54.3%) were enrolled during the pandemic (March 15, 2020, through December 31, 2021).
Patients enrolled during the pandemic were more likely to be older, to be male, to participate in the study for a shorter time, to have fewer total in-person visits, and to have a greater proportion of virtual visits.
The mean age was 58.9 years in the pre-pandemic group and 62.1 years in the pandemic group (P =.006). The proportion of male patients was 51.7% and 65.6%, respectively (P =.001). The mean length of time enrolled in the trial was 190 days and 144 days, respectively (P =.001).
The mean total number of physician visits was 10.2 pre-pandemic and 8.7 during the pandemic (P =.01). The mean proportion of virtual visits was 9% and 42%, respectively (P <.001).
Overall, 43.0% of patients reported at least 1 SAE. A multivariable analysis showed that patients enrolled during the pandemic had significantly lower odds of reporting at least 1 SAE (odds ratio, 0.52; 95% CI, 0.34-0.78; P =.002).
There was no association between the proportion of virtual visits and SAE reporting (odds ratio, 0.63; 95% CI, 0.35-1.16; P =.14).
“Although this pattern was not explained by increasing telehealth use, other long-term consequences of the pandemic, such as staffing shortages, higher administrative burdens, and frequent protocol changes, could have been associated with lower SAE reporting and should be explored in future studies,” the researchers wrote.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Ragavan MV, Legaspi N, LaLanne A, Hong JC, Small EJ, Borno HT. Analysis of serious adverse event reporting for patients enrolled in cancer clinical trials during the COVID-19 pandemic. JAMA Oncol. Published online October 27, 2022. doi:10.1001/jamaoncol.2022.4919
