招募患者对境外临床试验有何影响?

IF 3.1 Q1 Arts and Humanities Life Sciences, Society and Policy Pub Date : 2020-09-21 DOI:10.1186/s40504-020-00104-4
Maryam Kermanimojarad
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引用次数: 1

摘要

由于美国、欧洲和日本的海外研发活动越来越多,研究全球化问题受到了相当大的关注。本文探讨了这一现象,并提供了一个模型来分析可能有助于全球临床试验转型的因素。通过确定临床试验的主要特征,我旨在阐明临床研究迁移过程的主要驱动因素。我回顾了相关的已发表的文章,以解决研究问题。本研究的结果挑战了将成本相关因素作为离岸临床试验主要原因的传统思维,并显示了在试验中招募人类受试者的重要性。因此,本文认为,母国的“招聘危机”作为海外研发活动的主要贡献和关键驱动因素,被以往的研究低估了。特别是,本研究为决策者提供了一个新的视角来看待围绕制药行业的发展问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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What is the impact of patient recruitment on offshoring of clinical trials?

The issue of globalization of research is receiving considerable attention due to the increasing number of offshored R&D activities from the United States, Europe, and Japan. This paper explores this phenomenon and provides a model to analyze the factors that will likely contribute to a global transformation of clinical trials. By identifying the main characteristics of clinical trials, I aim to clarify the main driver of the relocation process of clinical research. I reviewed the relevant published articles to address the research questions. The results of this study challenge the traditional thinking of cost-related factors as the major reason for offshoring cilinical trials and show the importance of the recruitment of human subjects in trials. Consequently, this paper suggests that "recruitment crisis" in home country as the main contribution and a key driver to offshore R&D activities, has been underestimated by previous studies. In particular, this study provides policy-decision makers with a new insight into the development issue surrounding the pharmaceutical industry.

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来源期刊
Life Sciences, Society and Policy
Life Sciences, Society and Policy Arts and Humanities-Philosophy
自引率
0.00%
发文量
0
审稿时长
18 weeks
期刊介绍: The purpose of Life Sciences, Society and Policy (LSSP) is to analyse social, ethical and legal dimensions of the most dynamic branches of life sciences and technologies, and to discuss ways to foster responsible innovation, sustainable development and user-driven social policies. LSSP provides an academic forum for engaged scholarship at the intersection of life sciences, philosophy, bioethics, science studies and policy research, and covers a broad area of inquiry both in emerging research areas such as genomics, bioinformatics, biophysics, molecular engineering, nanotechnology and synthetic biology, and in more applied fields such as translational medicine, food science, environmental science, climate studies, research on animals, sustainability, science education and others. The goal is to produce insights, tools and recommendations that are relevant not only for academic researchers and teachers, but also for civil society, policy makers and industry, as well as for professionals in education, health care and the media, thus contributing to better research practices, better policies, and a more sustainable global society.
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