medwireNews: The frequency of serious adverse event (SAE) reporting in oncology clinical trials decreased significantly during the COVID-19 pandemic, report US researchers.
They note, however, that the decline was not linked to increased use of telehealth, and add: “[O]ther 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.”
For the study, Meera Ragavan and colleagues, from the University of California, San Francisco, identified 530 adults with a nongynecologic cancer who were enrolled in investigator-initiated phase 1–3 clinical trials at their institution for at least 14 days during January 2019–December 2021.
Just under half (45.7%) were recruited during the prepandemic period (January 1, 2019–March 14, 2020), while the remaining 54.3% were enrolled during the pandemic (March 15, 2020–December 31, 2021).
In all, 43% of participants experienced an SAE, and multivariable analysis revealed that the likelihood of reporting at least one SAE was a significant 48% lower for participants enrolled during versus before the pandemic period.
“No association existed between the proportion of virtual visits and SAE reporting, including in a subgroup analysis of only patients enrolled during the pandemic,” write Ragavan et al in a research letter to JAMA Oncology.
They conclude: “The findings suggest that remote monitoring may be safe for patients enrolled in oncology clinical trials; however, larger studies are needed to validate the association between virtual visits and SAE reporting.”
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2022 Springer Healthcare Ltd, part of the Springer Nature Group
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