Covid-19期间的临床试验

Abigail Mk
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引用次数: 1

摘要

当前的2019年新型冠状病毒病(COVID-19)大流行导致了健康风险、获得卫生保健和日常互动方面的重大变化。通过这些和其他挑战,大流行正在影响正在进行的临床试验,这些试验正在评估旨在预防或治疗COVID-19以外疾病的干预措施。在没有仔细考虑统计分析的后果的情况下,对方案规定的依从性和保留研究参与者的程序的实施进行有意义的改变,可能会损害大流行后环境中所研究干预措施的有效性和安全性的临床试验结果的普遍性[1]。
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Clinical Trials during Covid-19
The current novel coronavirus disease 2019 (COVID-19) pandemic has led to substantial changes in health risks, access to health care, and daily interactions. Through these and other challenges, the pandemic is affecting ongoing clinical trials that are evaluating interventions aimed at preventing or treating diseases other than COVID-19. Meaningful alterations to the implementation of protocol-specified procedures for adherence and retention of study participants, without careful consideration of the consequences to statistical analysis, can compromise the generalizability of clinical trial results about efficacy and safety of studied interventions in the postpandemic setting [1].
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