当前的研究在很大程度上倾向于忽略“第二世界”中开发的药物测试模型,作为随机对照试验的明确替代方案。这个系统可以被描述为“社会主义政治,“考虑到影响实验药物开发和测试的国家社会主义的具体特征。“第二世界”采用的临床试验模型受到苏联的严重影响,到目前为止,这是冷战期间社会主义集团中最具影响力的参与者。基于广泛的档案研究,本文介绍了一个苏联晚期临床试验的经验案例,作为随机对照试验模型的务实替代方案。它解释了苏联当局规定的官方模式与医疗实践的混乱现实之间的分歧。它进一步概述了不同的因素,这些因素最终决定了苏联机构在当地的临床试验是如何组织的。\"因此,本文介绍了“社会主义医药政治”的“现实生活”历史,并概述了该系统在实践中面临的问题。
档案研究是在莫斯科的俄罗斯国家科学和技术文献档案馆进行的。档案文件包括科学,技术,和注册文件,如生化,药理学,以及实验药物Meldonium的临床描述,不同医院之间的信件,研究机构和苏联监管机构,以及26份已完成的临床试验报告。手动内容分析用于结果的解释。
本文介绍了一个苏联晚期临床试验的经验案例,作为随机对照试验模型的实用替代方案。它显示了与随机对照试验模型的一些关键差异。本文还强调了苏联当局正式规定的模型与1980年代末和1990年代初苏联实验药物测试的现实之间的一些差异。特别是,它记录了随机化的一些元素,双盲,以及尽管受到苏联生物伦理学的正式谴责,但在Meldonium试验中存在的安慰剂的使用。
苏联试验试验药物的模式与西方试验药物的模式在许多方面有很大不同。这种差异不仅被苏联当局正式宣布,但在大多数情况下,在实践中的临床试验都是强制执行的。同时,我们的研究表明,官方模式与当地临床实际存在重要差异.
Current research largely tends to ignore the drug-testing model that was developed in the \"Second World\" as an explicit alternative to the randomized controlled
trial. This system can be described as \"socialist pharmapolitics,\" accounting for the specific features of state socialism that influenced the development and testing of experimental drugs. The clinical trials model employed in the \"Second World\" was heavily influenced by the Soviet Union, which was by far the most influential player in the socialist bloc during the Cold War. Based on extensive archival research, this article presents an empirical case of a late Soviet clinical trial as a pragmatic alternative to the randomized controlled
trial model. It accounts for the divergences between the official model prescribed by the Soviet authorities and the messy realities of healthcare practice. It further outlines different factors that ultimately shaped how clinical trials were organized in Soviet institutions \"on the ground.\" Accordingly, this article presents a \"real-life\" history of \"socialist pharmapolitics\" and outlines the problems that this system faced in practice.
Archival research was conducted at the Russian State Archive of Scientific and Technical Documentation in Moscow. Archival files include scientific, technical, and registration documentation such as biochemical, pharmacological, and clinical descriptions of the experimental drug Meldonium, letters between various hospitals, research institutes and the Soviet regulatory body, as well as 26 reports of completed clinical trials. Manual content analysis was used for the interpretation of results.
This article presents an empirical case of a late Soviet clinical
trial as a pragmatic alternative to the randomized controlled
trial model. It demonstrates some key differences from the randomized controlled
trial model. This article also highlights some of the discrepancies between the model that was officially prescribed by the Soviet authorities and the realities of experimental drug testing in the Soviet Union in the late 1980s and early 1990s. In particular, it notes some elements of randomization, double-blinding, and the use of placebo that were present in Meldonium trials despite being formally denounced by Soviet bioethics.
The Soviet model for testing experimental drugs differed from the Western one substantially in a number of respects. This difference was not only proclaimed officially by the Soviet authorities, but was for the most part enforced in clinical trials in practice. At the same time, our research demonstrates that there were important differences between the official model and the clinical realities on the ground.