Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations

Sylvia Baedorf Kassis, Weidong Lu, Sarah A. White, Anita Giobbie-Hurder, Anna M. Tanasijevic, Hyun-Jung Jung, Xiping Zhang, I. Shin, Sung-hoon Park, Young-Ju Jeong, C. Yao, J. Ligibel, Barbara E. Bierer
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Abstract

The global SARS-COV-2 pandemic has significantly impacted the delivery of clinical care as well as the conduct of international clinical trials. A coordinated, multinational acupuncture study, consisting of three parallel randomized studies with a planned pooled analysis of individual patient data, was initiated in 2019 with the goal of assessing whether acupuncture relieved hot flash symptoms in hormone receptor-positive breast cancer patients prescribed adjuvant endocrine therapy. Eligibility included persistent hot flashes on endocrine therapy. Participants were randomly assigned to receive either immediate or delayed acupuncture in equal proportions; the primary endpoint was assessed at week 10, after completion of the immediate acupuncture treatments and before the delayed treatment sessions began. The trial was conducted in China, South Korea and United States of America (USA) and was in the midst of enrollment and study procedures when the COVID-19 pandemic began. Despite numerous challenges, the study was nonetheless completed successfully. We deployed a process evaluation method to describe each site’s experiences in conducting this multinational study during the pandemic. Using these observations, we offer measures for the planning and conduct of future studies, taking into account preparedness considerations in the event of exigent and demanding global circumstances.
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在COVID-19大流行期间开展三国临床试验:经验和未来考虑
全球SARS-COV-2大流行严重影响了临床护理的提供和国际临床试验的开展。一项协调的多国针灸研究于2019年启动,该研究由三项平行随机研究组成,并计划对个体患者数据进行汇总分析,目的是评估针灸是否缓解激素受体阳性乳腺癌患者服用辅助内分泌治疗后的潮热症状。入选标准包括接受内分泌治疗的持续性潮热。参与者按相同比例随机分配接受即时或延迟针灸;主要终点在第10周,即完成即时针灸治疗后和延迟治疗开始前进行评估。该试验在中国、韩国和美利坚合众国(美国)进行,当COVID-19大流行开始时,该试验正在进行入组和研究程序。尽管面临诸多挑战,但这项研究还是成功完成了。我们采用了一种过程评估方法来描述每个站点在大流行期间开展这项多国研究的经验。利用这些观察结果,我们提供了规划和开展未来研究的措施,同时考虑到在紧急和苛刻的全球环境下的准备考虑。
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