Abstract
This chapter addresses challenges to the organization and conduct of international stem cell clinical trials in a context of regulatory pluralism. Multi-country clinical trial collaborations in stem cell medicine have the potential to speed up clinical developments and to widen access to new treatments among patients. However, the regulatory procedures through which the safety and efficacy of stem cell-based treatments are determined vary widely across countries. Internationally harmonized governance frameworks are not yet in place. In this chapter we show that this high level of regulatory variation and the absence of internationally binding standards for clinical stem cell research present important challenges to multi-country clinical trial collaborations. Four types of challenges will be highlighted. First is the need to inquire into and interact with regulatory procedures and law in multiple countries. Second, the interaction with medical authorities in multiple countries is resulting in a high level of organizational complexity. Third consists of delays, increased costs, and uncertainties that result from nonexistent, unclear, or still emerging regulatory arrangements in different countries. Fourth is that the high level of regulatory variation across countries necessitates far-reaching forms of scientific self-governance, training, and procedural adjustments in participating clinical trial sites. To illustrate this point, the chapter presents a case study of project-internal self-governance and capacity building in the context of a clinical trial infrastructure that is active across the contexts of China, Hong Kong, and the USA. The chapter concludes with a call for the creation of an international support structure that systematically addresses these problems. Five measures that may help to reduce existing difficulties will be introduced.
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Notes
- 1.
This chapter is based on three papers that I have published in 2014 and 2015. These papers are (1) Rosemann A (2015) Multi-country stem cell trials: the need for an international support structure. Stem Cell Res 14(3):396–400; (2) Rosemann A (2015) Stem cell treatments for neurodegenerative diseases: challenges from a science, business and healthcare perspectives, Neurodegener Dis Manag 5(2):85–87; and (3) Rosemann A (2014) Standardization as situation-specific achievement: regulatory diversity and the production of value in intercontinental collaborations in stem cell medicine. Soc Sci Med 122:72–80. I have rearranged information from these articles and developed them further in the context of this chapter. These articles have been published open access under a CC-BY license. I am permitted to use and reproduce segments of these texts in this chapter.
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This article has benefited from research support provided by the European Research Council (ERC: 283219) and the Economic and Social Science Research Council ESRC: ES/I018107/1). Due to ethical concerns, supporting data cannot be made openly available.
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Rosemann, A. (2017). Challenges to International Stem Cell Clinical Trials in Countries with Diverging Regulations. In: Pham, P., Rosemann, A. (eds) Safety, Ethics and Regulations. Stem Cells in Clinical Applications. Springer, Cham. https://doi.org/10.1007/978-3-319-59165-0_15
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DOI: https://doi.org/10.1007/978-3-319-59165-0_15
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