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What is the impact of patient recruitment on offshoring of clinical trials?
Life Sciences, Society and Policy Pub Date : 2020-09-21 , DOI: 10.1186/s40504-020-00104-4
Maryam Kermanimojarad 1
Affiliation  

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.



中文翻译:

患者招募对临床试验的离岸外包有何影响?

由于来自美国、欧洲和日本的海外研发活动越来越多,研究的全球化问题正受到相当大的关注。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临床试验全球转型的因素。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。我查阅了相关已发表的文章以解决研究问题。这项研究的结果挑战了将成本相关因素作为外包临床试验的主要原因的传统思维,并表明在试验中招募人类受试者的重要性。最后,本文认为,母国的“招聘危机”作为离岸研发活动的主要贡献和关键驱动因素,被先前的研究低估了。特别是,这项研究为政策决策者提供了对围绕制药行业发展问题的新见解。

更新日期:2020-09-21
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