Platonov P
Lund University, Lund, Sweden.
Int J Clin Pharmacol Ther. 2003 Jul;41(7):277-80. doi: 10.5414/cpp41277.
To review the current situation of clinical trials in Russia and Eastern Europe.
The volume of clinical trials in these territories is increasing. The quality of the data obtained, ethical care and compliance with Good Clinical Practice guidelines is at least as good as anywhere else. United States Food and Drug Administration inspection data indicate that sites in these countries are often superior to those elsewhere. Large-scale clinical trials conducted in these territories have been subsequently published in mainstream journals. Territory-specific attention must be paid to communications' equipment and language. However, this is countered, for example, by the fact that most clinical research associates in Russia hold degrees in medicine, that patients with previously untreated disease are more easily found than in North America or Western Europe, and the participation of large, purpose-built, healthcare institutions.
Eastern Europe and Russia are well-established locales for clinical trials. These territories offer a solution to the competition for patients among clinical trials in North America or Western Europe.
回顾俄罗斯和东欧的临床试验现状。
这些地区的临床试验数量在增加。所获得数据的质量、伦理关怀以及对《药物临床试验质量管理规范》指南的遵循程度至少与其他任何地方一样好。美国食品药品监督管理局的检查数据表明，这些国家的试验点往往优于其他地方。在这些地区开展的大规模临床试验随后已发表在主流期刊上。必须特别关注特定地区的通信设备和语言。然而，例如，俄罗斯大多数临床研究助理拥有医学学位、与北美或西欧相比更容易找到未接受过治疗的患者以及大型专门医疗机构的参与等事实，抵消了上述不利因素。
东欧和俄罗斯是成熟的临床试验地点。这些地区为北美或西欧临床试验之间的患者竞争提供了一个解决方案。
