International Trials

Lynette Blacher () and Linda Marillo ()
Additional contact information
Lynette Blacher: Frontier Science Amherst
Linda Marillo: Frontier Science Amherst

Chapter 19 in Principles and Practice of Clinical Trials, 2022, pp 347-368 from Springer

Abstract: 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.

Keywords: International clinical trials; General Data Protection Regulation (GDPR); Regulatory approval; ClinicalTrials.gov (search for similar items in EconPapers)
Date: 2022
References: Add references at CitEc
Citations:

There are no downloads for this item, see the EconPapers FAQ for hints about obtaining it.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-3-319-52636-2_44

Ordering information: This item can be ordered from
http://www.springer.com/9783319526362

DOI: 10.1007/978-3-319-52636-2_44

Access Statistics for this chapter

More chapters in Springer Books from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().