What is the impact of patient recruitment on offshoring of clinical trials?
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(2020) 16:10
REVIEW
Open Access
What is the impact of patient recruitment on offshoring of clinical trials? Maryam Kermanimojarad Correspondence: maryam. [email protected] Department of Public Policy and Social Change, Collegio Carlo Alberto, Turin, Italy
Abstract 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. Keywords: Offshoring, Cost-related factor, The recruitment process, Clinical trails
Introduction With access to essential medicine being one of the building blocks of the healthcare system, policy measures aimed at reducing healthcare spending growth at the international level have targeted primarily the pharmaceutical industry, over the past decade (Settanni 2017). The pharmaceutical sector is one of the most important industries overall and presents the highest research and development (R&D) intensity in the US and EU. The United States Pharmaceutical R&D expenditure has grown from 2 million USD in 1980 to 79.6 million USD in the year 2018, according to a survey of PHARMA members. Clinical trials (CT), a major part of R&D in pharmaceutical companies, have received much attention, over recent decades. However, globalization has led to the extension of clinical research outside higher-income regions, followed by a growing trend towards the offshore outsourcing of CT to “nontraditional locations’ such as Eastern Europe, China, and India (Cooper 2008; Clark and Newton 2004; Murthy et al. 2015). A considerable amount of literature has been published on cost-related factors for the internationalization of R&D activities, particularly as an explanatory factor for offshored CT. Nevertheless, © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The
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