俄罗斯临床研究市场:问题与展望

I. I. Tsarikov, S. Miheenko
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引用次数: 0

摘要

全球临床试验市场的目标是协调国际合作,以解决普遍提供高质量和可获得药物的问题。考虑到数字化无处不在的特性,现阶段阻碍临床研究行业社会主体密切国际合作的障碍有:伦理和法律监管的规则和要求的碎片化,以及这种研究在公众心目中的普及存在明显的劣势。俄罗斯临床试验部门在数字志愿者/患者搜索服务的发展方面落后,这降低了在人类参与下进行大规模有效临床试验的能力。本文介绍了目前全球互联网上流行的数字志愿者/患者搜索服务的比较分析数据,以了解它们是否符合消费者的要求,并提出了改进的建议。该研究的结果是确定了现代国际临床试验市场的问题领域,以及由于立法框架的不平衡和国内促进和吸引志愿者的数字平台质量低下而落后于俄罗斯部门的因素
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Russian Clinical Research Market: Problems and Prospects
The global market for clinical trials is directed at harmonizing international cooperation to address issues of universal provision of high quality and availability of medicines. Considering the ubiquitous nature of digitalization, at the present stage there are a number of barriers that impede the close international cooperation of social agents in the clinical research industry: the fragmentation of the rules and requirements of ethical and legal regulation, as well as significant disadvantages in the popularization of such research in the public mind. The Russian clinical trials sector is lagging behind in the development of digital volunteer/patient search services, that reduces the ability to conduct large valid clinical trials with human participation. The article presents data from a comparative analysis of popular digital volunteer/patient search services currently available on the global Internet for their compliance with the requirements of a consumer request, and also suggests options for their improvement. The result of the study was the identification of problem areas of the modern market for international clinical trials, as well as factors lagging behind the Russian sector due to the imbalance of the legislative framework and the low quality of domestic digital platforms for promoting and attracting volunteers
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