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反对用安慰剂对照试验来评估新冠疫苗。

"No" to placebo-controlled trials of Covid-19 vaccines.

机构信息

Dean and Chief Nephrologist, Member WHO Ethics & COVID-19 Expert Group and The Kidney Centre Postgraduate Training Institute, Karachi 75530, PAKISTAN.

The Kidney Centre Postgraduate Training Institute, Karachi 75530, PAKISTAN.

出版信息

Indian J Med Ethics. 2021 Apr-Jun;VI(2):1-7. doi: 10.20529/IJME.2021.019.

Abstract

Recently the WHO Ad Hoc Expert Group proposed that it is ethical to continue placebo-controlled Covid-19 vaccine trials in countries where vaccines are not available even if this vaccine is marketed and being used elsewhere. The reason for this proposal is the usual scientific argument claiming that these trials are the most efficient method to obtain reliable results, and individuals in these countries will continue to get the local standard of care, meaning no vaccination, and thus participants are not being left worse off. We refute this argument on two counts. First the global equity and justice issue, that the scarcity of vaccines in most countries is created by the rich nations that have hoarded vaccines. Second, the science versus research ethics issue, that there are valid scientific methods like non-inferiority trials which can give reliable results, and that applying a standard of care imposed by rich nations is both unethical and possibly exploitative. Thus, we feel that the WHO Ad Hoc Expert Group is wrong in proposing to continue placebo-controlled Covid-19 vaccine trials.

摘要

最近,世界卫生组织临时专家组提出,即使疫苗在其他地方已经上市和使用,在疫苗供应不足的国家继续进行安慰剂对照的 COVID-19 疫苗试验在伦理上是可以接受的。提出这一建议的原因是通常的科学论点,即这些试验是获得可靠结果的最有效方法,而且这些国家的个人将继续接受当地的标准治疗,这意味着不进行疫苗接种,因此参与者不会受到更严重的影响。我们从两个方面反驳了这一论点。首先是全球公平和正义问题,即大多数国家疫苗短缺是由囤积疫苗的富裕国家造成的。其次,是科学与研究伦理问题,即有有效的科学方法,如非劣效性试验,可以给出可靠的结果,而且采用富裕国家强加的标准治疗既不道德,也可能具有剥削性。因此,我们认为世界卫生组织临时专家组提出继续进行安慰剂对照的 COVID-19 疫苗试验是错误的。

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