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在一家三级癌症中心的新型冠状病毒肺炎大流行期间,实体恶性肿瘤临床研究的患者招募情况。

Patient recruitment into clinical studies of solid malignancies during the COVID-19 pandemic in a tertiary cancer center.

作者信息

von der Grün Jens, Ahmadsei Maiwand, Breyer Isabel, Britschgi Christian, Eberli Daniel, Hermanns Thomas, Mangana Joanna, Petrowsky Henrik, Ramelyte Egle, Roth Patrick, Schär Gabriel, Opitz Isabelle, Weller Michael, Wicki Andreas, Witzel Isabell, Balermpas Panagiotis, Guckenberger Matthias

机构信息

Department of Radiation Oncology, University Hospital Zurich and University of Zurich, Zurich, Switzerland; Comprehensive Cancer Center Zurich, University Hospital Zurich and University of Zurich, Zurich, Switzerland.

Department of Radiation Oncology, University Hospital Zurich and University of Zurich, Zurich, Switzerland; Comprehensive Cancer Center Zurich, University Hospital Zurich and University of Zurich, Zurich, Switzerland.

出版信息

Neoplasia. 2023 Oct 27;46:100946. doi: 10.1016/j.neo.2023.100946.

Abstract

BACKGROUND AND PURPOSE

To analyze clinical trial activities and patient recruitment numbers into prospective clinical studies for solid malignancies during the COVID-19 pandemic in a tertiary cancer center.

MATERIALS AND METHODS

Patient recruitment numbers in prospective clinical studies of solid malignancies were retrospectively analyzed for the years 2019 - 2021 at the Comprehensive Cancer Center Zurich (CCCZ). Changes in recruitment numbers were tested for association with organ-specific subunits, as well as organizational and treatment-related trial characteristics. To assess differences between categorical variables, Chi-squared test was used. For uni- and multivariate analysis, Cox proportional hazards were calculated.

RESULTS

In 2019, there were a total of 107 studies (registry trials, clinical phase I-III trials, and translational studies) recruiting 304 patients at the CCCZ. During the COVID-19 pandemic in 2020 and 2021, there were 120 and 125 active trials with a total recruitment of 355 and 666 patients, respectively. No significant differences between the subunits and study characteristics in changes of patient recruitment in clinical phase I-III trials were identified when the year prior to the COVID-19 pandemic (2019) was compared to the first year of the pandemic (2020) and to 2020-2021.

CONCLUSIONS

Despite healthcare systems around the world have experienced significant disruption due to the COVID-19 pandemic, data from our tertiary cancer center showed that clinical trial activities were maintained at a high level during the pandemic.

摘要

背景与目的

分析在一家三级癌症中心,2019冠状病毒病大流行期间实体恶性肿瘤前瞻性临床研究的临床试验活动及患者招募数量。

材料与方法

对苏黎世综合癌症中心(CCCZ)2019 - 2021年实体恶性肿瘤前瞻性临床研究中的患者招募数量进行回顾性分析。测试招募数量的变化与器官特异性亚组以及组织和治疗相关试验特征之间的关联。为评估分类变量之间的差异,使用卡方检验。对于单因素和多因素分析,计算Cox比例风险。

结果

2019年,CCCZ共有107项研究(注册试验、临床I - III期试验和转化研究)招募了304名患者。在2020年和2021年的2019冠状病毒病大流行期间,分别有120项和125项正在进行的试验,总共招募了355名和666名患者。将2019冠状病毒病大流行前一年(2019年)与大流行第一年(2020年)以及2020 - 2021年进行比较时,未发现临床I - III期试验中患者招募变化的亚组与研究特征之间存在显著差异。

结论

尽管全球医疗系统因2019冠状病毒病大流行而经历了重大干扰,但我们三级癌症中心的数据显示,大流行期间临床试验活动保持在较高水平。

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