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Despite negative perceptions of clinical trial conduct during the coronavirus disease 2019 (COVID-19) pandemic, are decentralized clinical trial methods here to stay?尽管在2019年冠状病毒病（COVID-19）大流行期间人们对临床试验的开展存在负面看法，但去中心化临床试验方法会就此留存下来吗？
Ann Transl Med. 2023 Feb 28;11(4):159. doi: 10.21037/atm-23-5. Epub 2023 Feb 6.
2
Impact of the COVID-19 pandemic on clinical trials: a cross-sectional questionnaire study in China.2019年冠状病毒病大流行对临床试验的影响：一项在中国进行的横断面问卷调查研究
Ann Transl Med. 2022 Nov;10(21):1154. doi: 10.21037/atm-22-777.
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The impact of COVID-19 on cancer care and oncology clinical research: an experts' perspective.COVID-19 对癌症护理和肿瘤临床研究的影响：专家观点。
ESMO Open. 2022 Feb;7(1):100339. doi: 10.1016/j.esmoop.2021.100339. Epub 2021 Nov 23.
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The Impact of COVID-19 on the Conduct of Clinical Trials for Medical Products in Korea.新冠疫情对韩国医疗产品临床试验开展的影响。
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Clin Cancer Res. 2020 Jul 1;26(13):3100-3103. doi: 10.1158/1078-0432.CCR-20-1364. Epub 2020 Apr 20.
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Impact of Using A Mixed Data Collection Modality on Statistical Inferences in Decentralized Clinical Trials.混合数据采集模式对去中心化临床试验统计推断的影响。
Ther Innov Regul Sci. 2022 Sep;56(5):744-752. doi: 10.1007/s43441-022-00416-x. Epub 2022 May 24.
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A qualitative study to explore primary health care practitioners' perceptions and understanding regarding the COVID-19 pandemic in KwaZulu-Natal, South Africa.一项在南非夸祖鲁-纳塔尔省探究基层医疗保健从业者对 COVID-19 大流行的认知与理解的定性研究。
Afr J Prim Health Care Fam Med. 2021 Nov 26;13(1):e1-e11. doi: 10.4102/phcfm.v13i1.3084.
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The Impact of the COVID-19 Pandemic on Oncology Care and Clinical Trials.2019冠状病毒病大流行对肿瘤护理和临床试验的影响。
Cancers (Basel). 2021 Nov 25;13(23):5924. doi: 10.3390/cancers13235924.
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Is it possible to conduct clinical trials during a pandemic? The example of a trial of hydroxychloroquine.在大流行期间是否可以进行临床试验？羟氯喹试验的例子。
Epidemiol Prev. 2021 Jan-Apr;45(1-2):28-36. doi: 10.19191/EP21.1-2.P028.036.
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Conducting clinical trials in heart failure during (and after) the COVID-19 pandemic: an Expert Consensus Position Paper from the Heart Failure Association (HFA) of the European Society of Cardiology (ESC).在（和之后） COVID-19 大流行期间进行心力衰竭临床试验：欧洲心脏病学会（ESC）心力衰竭协会（HFA）的专家共识立场文件。
Eur Heart J. 2020 Jun 7;41(22):2109-2117. doi: 10.1093/eurheartj/ehaa461.

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1
Recommendations to promote equity, diversity and inclusion in decentralized clinical trials.促进去中心化临床试验中公平、多样性和包容性的建议。
Nat Med. 2024 Nov;30(11):3075-3084. doi: 10.1038/s41591-024-03323-w. Epub 2024 Oct 29.

本文引用的文献

1
Impact of the COVID-19 pandemic on clinical trials: a cross-sectional questionnaire study in China.2019年冠状病毒病大流行对临床试验的影响：一项在中国进行的横断面问卷调查研究
Ann Transl Med. 2022 Nov;10(21):1154. doi: 10.21037/atm-22-777.
2
Changes in Doctor-Patient Relationships in China during COVID-19: A Text Mining Analysis.新冠疫情期间中国医患关系的变化：文本挖掘分析
Int J Environ Res Public Health. 2022 Oct 18;19(20):13446. doi: 10.3390/ijerph192013446.
3
Which decentralised trial activities are reported in clinical trial protocols of drug trials initiated in 2019-2020? A cross-sectional study in ClinicalTrials.gov.在 2019-2020 年启动的药物试验的临床试验方案中，报告了哪些去中心化试验活动？ClinicalTrials.gov 中的一项横断面研究。
BMJ Open. 2022 Aug 29;12(8):e063236. doi: 10.1136/bmjopen-2022-063236.
4
Opportunities and Challenges for Decentralized Clinical Trials: European Regulators' Perspective.去中心化临床试验的机遇与挑战：欧洲监管机构视角。
Clin Pharmacol Ther. 2022 Aug;112(2):344-352. doi: 10.1002/cpt.2628. Epub 2022 May 17.
5
The Impact of the COVID-19 Pandemic on Oncology Care and Clinical Trials.2019冠状病毒病大流行对肿瘤护理和临床试验的影响。
Cancers (Basel). 2021 Nov 25;13(23):5924. doi: 10.3390/cancers13235924.
6
"Old friend and powerful cadre": Doctor-patient relationships and multi-dimensional therapeutic landscapes in China's primary hospitals.“老朋友和有影响力的干部”：中国基层医院的医患关系和多维治疗景观。
Health Place. 2021 Nov;72:102708. doi: 10.1016/j.healthplace.2021.102708. Epub 2021 Nov 3.
7
Impact of Personal Cooling on Performance, Comfort and Heat Strain of Healthcare Workers in PPE, a Study From West Africa.个人降温对穿戴个人防护装备的医护人员的性能、舒适度和热应激的影响：来自西非的一项研究。
Front Public Health. 2021 Sep 1;9:712481. doi: 10.3389/fpubh.2021.712481. eCollection 2021.
8
Impact of COVID-19 on Public Knowledge and Attitudes Toward Participating in Clinical Trials in Saudi Arabia: A Cross-Sectional Study.2019年冠状病毒病对沙特阿拉伯公众参与临床试验的认知和态度的影响：一项横断面研究
Int J Gen Med. 2021 Jul 13;14:3405-3413. doi: 10.2147/IJGM.S318753. eCollection 2021.
9
Impact of the COVID-19 Pandemic on Cancer Clinical Trials.COVID-19 大流行对癌症临床试验的影响。
Ann Surg Oncol. 2021 Nov;28(12):7311-7316. doi: 10.1245/s10434-021-10406-2. Epub 2021 Jul 8.
10
The impact of COVID-19 on the clinical trial.新型冠状病毒肺炎对临床试验的影响。
PLoS One. 2021 May 11;16(5):e0251410. doi: 10.1371/journal.pone.0251410. eCollection 2021.

Despite negative perceptions of clinical trial conduct during the coronavirus disease 2019 (COVID-19) pandemic, are decentralized clinical trial methods here to stay?

作者信息

Cooper Lisa, Jose Nadina

机构信息

Department of Health Informatics, School of Health Professions, Rutgers, The State University of New Jersey, Newark, NJ, USA.

出版信息

Ann Transl Med. 2023 Feb 28;11(4):159. doi: 10.21037/atm-23-5. Epub 2023 Feb 6.

DOI:10.21037/atm-23-5
PMID:36923074
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10009564/
Abstract
摘要