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International Trials

In: Principles and Practice of Clinical Trials

Author

Listed:
  • Lynette Blacher

    (Frontier Science Amherst)

  • Linda Marillo

    (Frontier Science Amherst)

Abstract

The number of international clinical trials being activated has increased greatly over recent years. There are valid reasons for this global expansion, including a need for greater numbers of subjects enrolled in as short a time as possible, application to diverse populations, and the potential for cost reduction. However, conducting trials internationally involves its own set of challenges related to every aspect of trial conduct, from site activation to data management. Challenges are primarily related to cultural, procedural, and regulatory differences between countries. The new General Data Protection Regulation (GDPR) (eugdpr.org/) in Europe is also affecting the conduct of these trials. This chapter details these challenges, as well as offering possible mitigation strategies.

Suggested Citation

  • Lynette Blacher & Linda Marillo, 2022. "International Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 19, pages 347-368, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-52636-2_44
    DOI: 10.1007/978-3-319-52636-2_44
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