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

chapter
posted on 2023-06-08, 23:47 authored by Achim Rosemann
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.

Funding

Bionetworking in Asia: Biomaterials and Cell Bank Regimes; ERC; 283219

Bionetworking in Asia: Patient Recruitment & Therapy Practices; ESRC; ES/I018107/1

History

Publication status

  • Published

File Version

  • Accepted version

Publisher

Springer

Volume

5

Page range

301-319

Pages

327.0

Book title

Safety, ethics and regulations

Place of publication

Heidelberg and New York

ISBN

9783319591643

Department affiliated with

  • Anthropology Publications

Full text available

  • No

Peer reviewed?

  • Yes

Editors

Achim Rosemann, Phuc Van Pham

Legacy Posted Date

2015-12-21

First Compliant Deposit (FCD) Date

2017-05-26

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