新冠肺炎期间/后开展心衰临床试验专家共识2020

2020-06-12 欧洲心力衰竭协会 Eur Heart J. 2020 Jun 7;41(22):2109-2117

由严重急性呼吸综合征冠状病毒2(SARS-CoV-2)引起的2019年冠状病毒病(COVID-19)大流行,对临床试验参与者和护理他们的研究人员的安全有重要影响,进而对试验本身也有重要影响。心力衰竭患

中文标题:

新冠肺炎期间/后开展心衰临床试验专家共识2020

英文标题:

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)

发布机构:

欧洲心力衰竭协会

发布日期:

2020-06-12

简要介绍:

由严重急性呼吸综合征冠状病毒2(SARS-CoV-2)引起的2019年冠状病毒病(COVID-19)大流行,对临床试验参与者和护理他们的研究人员的安全有重要影响,进而对试验本身也有重要影响。心力衰竭患者感染COVID-19的风险可能更大,后果也可能更严重,但如果他们的临床护理受到影响,也有可能出现不良后果。作为医生和临床试验人员,我们有责任在不影响试验完整性的前提下,确保为试验参与者提供安全有效的护理。与患者签订的社会契约也要求我们这样做。在这次COVID-19危机中,世界上不同地区的许多监管机构都发布了关于开展临床试验的指导声明。然而,国际试验可能会受益于全球专家组的专家指导,以补充当地的建议和法规,从而提高参与者的安全性和试验的完整性。因此,欧洲心脏病学会心力衰竭协会于2020年3月21日和22日与欧洲、北美、南美、澳大利亚和亚洲的临床试验专家进行了网络会议。本次专家立场书的主要目的是强调这种流行病对心衰临床试验的开展所带来的挑战,并就如何克服这些挑战提出建议,并列举一些实际案例。虽然本专家小组的重点是心衰临床试验,但这些讨论和建议可能适用于其他治疗领域的临床试验。

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    2020-09-08 ms1000000302953060

    机床

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    2020-09-01 逆行星

    谢谢

    0

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    2020-08-11 ms5000001961239662

    认真学习

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    2020-08-11 ms5000001961239662

    认真阅读

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    2020-08-11 ms5000001961239662

    谢谢

    0