乌克兰涉及人类受试者的研究:如何利用出现的机会?

A. Cherkas
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引用次数: 2

摘要

对乌克兰国家研究基金会拨款申请的审查显示,有证据表明,许多申请人-临床医生不了解良好临床实践(GCP)的原则,而这些原则在全球绝大多数涉及人类受试者的研究中以不同的形式实施。在这篇文章中,基于在达尼洛·哈利茨基·利沃夫国立医科大学(乌克兰)、洛马琳达大学(美国)、耶拿弗里德里希·席勒大学(德国)以及行业(赛诺菲-安万特-德国有限公司)的研究经验。作者分享了他对乌克兰在教育、培训、法规和管理缺陷方面的差距的看法,这些差距阻碍了乌克兰临床研究的更快进展。尽管问题很复杂,但如建议的那样,在机构和(或)国家一级执行相对简单的步骤可以提高研究效率,提高应用质量,并将乌克兰的临床研究提高到一个质量不同的水平
本文章由计算机程序翻译,如有差异,请以英文原文为准。
RESEARCH INVOLVING HUMAN SUBJECTS IN UKRAINE: HOW TO LEVERAGE ARISING OPPORTUNITIES?
The review of the applications for grants of the National Research Foundation of Ukraine revealed evidence that many applicants-clinicians are not aware of the principles of Good Clinical Practice (GCP) that are implemented in different forms in the vast majority of research involving human subjects across the globe. In the essay, based on the experience of researching at Danylo Halytsky Lviv National Medical University (Ukraine), Loma Linda University (USA), Friedrich Schiller University Jena (Germany), as well as industry (Sanofi-Aventis-Deutschland GmbH., Frankfurt am Main, Germany), the author shares his thoughts about the gaps in education, training, regulations and administrative flaws that prevent more rapid progress in clinical research in Ukraine. Despite the complexity of the problem, implementation of relatively simple steps at institutional and/or national levels, as suggested, can boost the efficiency of research, increase the quality of applications and move clinical research in Ukraine to a qualitatively different level
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