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Elsevier - PMC COVID-19 Collection logoLink to Elsevier - PMC COVID-19 Collection
. 2021 Dec 27;164(1):18. doi: 10.1016/j.ygyno.2021.10.012

The COVID-19 pandemic did not adversely affect clinical trial enrollment in gynecologic oncology trials at a single academic institution

Courtney Bailey a, Sharad Ghamande b, Lynn Tran b, Bunja Rungruang c, Donna Wheatley b, Robert Higgins d
PMCID: PMC9753595  PMID: 34696892

Objectives

The objective of this study was to compare enrollment of patients with gynecologic cancers at our institution in 2019, before the COVID-19 pandemic, with enrollment in 2020, during the pandemic.

Methods

Clinical trial enrollment data was obtained through the clinical trials office. Patients enrolled in gynecologic oncology therapeutic trials (excluding maintenance trials) in 2019 and 2020 were compared using Wilcoxon Rank Sum testing. The number of patients enrolled in each clinical trial phase (Phase 1–3) and each disease site were also compared between 2019 and 2020. Standard descriptive statistics were used to compare demographic data of the clinical trial enrollees.

Results

Total patient enrollment for 2019 was 56 patients, and 45 patients enrolled in 2020. There was no statistically significant difference between 2019 and 2020 in the number of patients enrolled in clinical therapeutic trials at our institution by quarter (p-value 0.486). There was no statistically significant difference between the two years in the number of patients enrolled by disease site (p = 0.476) or in the phase of clinical trial in which patients enrolled (p = 0.126). The mean age of patients enrolled was similar (58.5 vs 60.7 years, p = 0.432). The mean distance traveled to our site was also similar between the two years (66.5 vs 76.0 miles, p = 0.687).

Conclusions

Unlike many other centers throughout the United States, clinical trial enrollment at our institution remained similar during the COVID-19 pandemic compared to the prior year. We attribute the continued enrollment of patients in clinical trials to several factors. These factors include the dedication of our research team to work on-site, the ability of our non-profit patient-accommodation facility to remain open, and the commitment of our gynecologic cancer support group to continue to hold events virtually.

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Articles from Gynecologic Oncology are provided here courtesy of Elsevier

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