Cancer clinical trials recover from substantial disruption during COVID-19 pandemic
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Oncology clinical trials appeared to recover from declines in enrollment and activation during the early phase of the COVID-19 pandemic, according to a study of data from two large academic centers published in Annals of Oncology.
Researchers found academically sponsored trials experienced more prominent declines than industry-sponsored trials, and they observed racial disparities among patients taken off clinical trials.
Rationale and methods
“Clinical trials are resource-intensive endeavors that are particularly susceptible to disruption by the pandemic, but are crucial to advancing cancer care,” Sheena Bhalla, MD, assistant professor in the division of hematology and oncology in the department of internal medicine at UT Southwestern Medical Center’s Harold C. Simmons Comprehensive Cancer Center, told Healio. “We were interested in evaluating the impact of the pandemic on clinical trial conduct and specifically studied the effect of the pandemic on therapeutic clinical trials at two large academic centers in the Northeastern United States.”
The prospective, multicenter study included 4,756 new patients with cancer enrolled in clinical trials at Dana-Farber Cancer Institute or the Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai between 2019 and 2021.
The study included an institution-wide cohort of new patient accruals to oncologic trials, a manually curated cohort of patients with cancer and a data set of new trial activations.
Primary objectives included assessment of enrollment on, accrual to and activation of oncology therapeutic clinical trials during the pandemic.
Key findings
Results showed a 46% overall decrease in the number of new patient accruals from March to May of 2020 compared with the 3 months prior to the pandemic. However, ongoing recovery and return to higher-than-normal levels (up 2.6% compared with the prepandemic period) followed this decrease. The number of newly activated trials also dropped sharply early in the pandemic — by 23.6% — but from March to May 2021 rebounded to a level 30.4% higher than before the pandemic.
Researchers observed a more prominent decrease in new patient accruals among academically sponsored trials compared with industry sponsored trials (P < .05).
Results of the manually curated cohort including 2,361 patients with cancer showed nonwhite patients had a higher likelihood of being taken off trial during the early phase of the pandemic (adjusted OR = 2.6; 95% CI, 1-6.63).
Study limitations included the inability to include an external cohort from another academic institution or cooperative group to further validate the findings.
Implications
“Our findings suggest that academic cancer centers were able to adapt to COVID-19-related disruptions in clinical trial activities,” Bhalla said. “The lessons learned during this challenging time may improve patient clinical trial access and protocol adaptability in the future. A follow-up of this research may be conducted 1 year after the last time period evaluated in the current study.”
References:
- Bakouny Z, et al. Ann Oncol. 2022;doi:10.1016/j.annonc.2022.04.071.
- Cancer clinical trials bounce back after significant COVID-19 disruption: Data from two large U.S. cancer centers (press release). Available at: www.esmo.org/newsroom/press-releases/cancer-clinical-trials-bounce-back-after-significant-covid-19-disruption-data-from-two-large-us-cancer-centres. Published June 15, 2022. Accessed July 5, 2022.
For more information:
Sheena Bhalla, MD, can be reached at sheena.bhalla@utsouthwestern.edu.
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