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在 COVID-19 大流行期间开展支持性肿瘤临床试验:挑战与策略。

Conducting a supportive oncology clinical trial during the COVID-19 pandemic: challenges and strategies.

机构信息

University of Pennsylvania, Philadelphia, PA, USA.

Vanderbilt-Ingram Cancer Center, Nashville, TN, USA.

出版信息

Trials. 2022 Nov 8;23(1):927. doi: 10.1186/s13063-022-06804-w.

DOI:10.1186/s13063-022-06804-w
PMID:36348346
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9640795/
Abstract

The coronavirus disease 2019 (COVID-19) pandemic resulted in severe interruptions to clinical research worldwide. This global public health crisis required investigators and researchers to rapidly develop and implement new strategies and solutions to mitigate its negative impact on the progress of clinical trials. In this paper, we describe the challenges, strategies, and lessons learned regarding the continuation of a supportive oncology clinical trial during the pandemic. We hope to provide insight into the implementation of clinical trials during a public health emergency to be better prepared for future instances.Trial registration: ClinicalTrials.gov, a service of the US National Institute of Health (NCT03030859). Registered on 22 January 2017.

摘要

2019 年冠状病毒病(COVID-19)大流行导致全球临床研究严重中断。这场全球公共卫生危机要求调查人员和研究人员迅速制定和实施新的策略和解决方案,以减轻其对临床试验进展的负面影响。在本文中,我们描述了在大流行期间继续进行支持性肿瘤学临床试验所面临的挑战、策略和经验教训。我们希望为实施临床试验提供一些见解公共卫生紧急情况,以便为未来的情况做好更好的准备。试验注册:ClinicalTrials.gov,美国国立卫生研究院(NCT03030859)的一项服务。于 2017 年 1 月 22 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e578/9641758/63aea2aa6a61/13063_2022_6804_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e578/9641758/63aea2aa6a61/13063_2022_6804_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e578/9641758/63aea2aa6a61/13063_2022_6804_Fig1_HTML.jpg

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本文引用的文献

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J Cardiovasc Dev Dis. 2022 Jan 10;9(1):19. doi: 10.3390/jcdd9010019.
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COVID-19 Pandemic and Trends in Clinical Trials: A Multi-Region and Global Perspective.COVID-19大流行与临床试验趋势:多区域及全球视角
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Photobiomodulation Therapy in Head and Neck Cancer-Related Lymphedema: A Pilot Feasibility Study.光生物调节疗法治疗头颈部癌相关淋巴水肿:一项初步可行性研究。
癌症中心的支持性肿瘤学:一个新科室的发展(2017 - 2021年)
Support Care Cancer. 2023 Nov 13;31(12):692. doi: 10.1007/s00520-023-08110-w.
Integr Cancer Ther. 2021 Jan-Dec;20:15347354211037938. doi: 10.1177/15347354211037938.
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Impact of COVID-19 on clinical trials and clinical research: A systematic review.2019冠状病毒病对临床试验和临床研究的影响:一项系统综述
Nepal J Epidemiol. 2020 Sep 30;10(3):878-887. doi: 10.3126/nje.v10i3.31622. eCollection 2020 Sep.
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Self-care for head and neck cancer survivors with lymphedema and fibrosis: study protocol for a randomized controlled trial.头颈部癌症幸存者淋巴水肿和纤维化的自我护理:一项随机对照试验的研究方案
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