Challenges to international stem cell clinical trials in countries with diverging regulations

Rosemann, Achim (2017) Challenges to international stem cell clinical trials in countries with diverging regulations. In: Pham, Phuc Van and Rosemann, Achim (eds.) Safety, ethics and regulations. Springer, Heidelberg and New York, pp. 301-319. ISBN 9783319591643

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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.

Item Type: Book Section
Schools and Departments: School of Global Studies > Anthropology
Subjects: R Medicine > RA Public aspects of medicine > RA0001 Medicine and the state. Including medical statistics, medical economics, provisions for medical care, medical sociology > RA0399 Regulation of medical practice. Evaluation and quality control of medical care. Medical audit
R Medicine > RA Public aspects of medicine > RA0001 Medicine and the state. Including medical statistics, medical economics, provisions for medical care, medical sociology > RA0418 Medicine and society. Social medicine. Medical sociology
R Medicine > RA Public aspects of medicine > RA0418 Medicine and society. Social medicine. Medical sociology
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Depositing User: Achim Rosemann
Date Deposited: 21 Dec 2015 09:29
Last Modified: 25 Aug 2017 09:49
URI: http://sro.sussex.ac.uk/id/eprint/58892

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Project NameSussex Project NumberFunderFunder Ref
Bionetworking in Asia: Biomaterials and Cell Bank RegimesUnsetERC283219
Bionetworking in Asia: Patient Recruitment & Therapy PracticesUnsetESRCES/I018107/1