新型冠状病毒肺炎大流行期间肿瘤学随机临床试验的暂停：与新冠相关暂停情况的横断面评估

Suspension of Oncology Randomized Clinical Trials during the COVID-19 Pandemic: A Cross-Sectional Evaluation of COVID-Related Suspensions.

作者信息

Sayyid Rashid K, Hiffa Anthony, Woodruff Phillip, Oberle Michael D, Lambert Joshua H, Terris Martha K, Wallis Christopher J D, Klaassen Zachary

机构信息

Section of Urology, Department of Surgery, Augusta University, Augusta, GA, USA.

Georgia Cancer Center, Augusta University, Augusta, GA, USA.

出版信息

Cancer Invest. 2022 Oct;40(9):743-749. doi: 10.1080/07357907.2022.2104305. Epub 2022 Aug 23.

DOI:10.1080/07357907.2022.2104305

PMID:35852930

Abstract

We conducted a cross-sectional analysis of ClinicalTrials.gov-registered oncology randomized controlled trials between September 2019 and December 2021 to identify predictors of trial suspensions. The dataset included 1,183 oncology trials, of which 384 (32.5%) were suspended. COVID-19 accounted for 47 (12.2%) suspensions. Trials that were single center- or US-based had higher odds of COVID-19 (ORs: 3.85 and 2.48, 95% CIs: 1.60-11.50 and 1.28-4.93, respectively) or any-reason suspensions (ORs: 2.33 and 2.04, 95% CIs: 1.46-3.45 and 1.40-2.76, respectively). Phase two (OR 1.27), three (OR 6.45) and four trials (OR 11.5) had increased odds of COVID-19 suspensions, compared to phase one trials.

摘要

我们对2019年9月至2021年12月期间在ClinicalTrials.gov注册的肿瘤学随机对照试验进行了横断面分析，以确定试验暂停的预测因素。该数据集包括1183项肿瘤学试验，其中384项（32.5%）被暂停。COVID-19导致47项（12.2%）试验暂停。单中心或美国的试验因COVID-19（比值比分别为3.85和2.48，95%置信区间分别为1.60-11.50和1.28-4.93）或任何原因暂停的几率更高（比值比分别为2.33和2.04，95%置信区间分别为1.46-3.45和1.40-2.76）。与一期试验相比，二期试验（比值比1.27）、三期试验（比值比6.45）和四期试验（比值比11.5）因COVID-19暂停的几率增加。