Abstract
Multicenter clinical trial designs offer a unique opportunity to leverage the diversity of patient populations in multiple geographic locations, share the burden of resource acquisition, and collaborate in the development of research questions and approaches. In a time of increasing globalization and rapid technological advancement, investigators are better able to conduct such projects seamlessly, benefiting investigators, sponsors, and patient populations. Regulatory agencies have embraced this shift towards the use of multicenter clinical trials in product development and have issued statements and guidance documents promoting their utility and offering best practices. Some governmental health agencies have even formed clinical trial networks to facilitate the use of multicenter clinical trials to answer a broad range of clinical questions related to a disease or disease area. This chapter will cover design considerations, data coordination, regulatory requirements, and study monitoring of multicenter clinical trials as well as how they can be conducted with a clinical trial network.
Original language | English (US) |
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Title of host publication | Principles and Practice of Clinical Trials |
Publisher | Springer International Publishing |
Pages | 135-150 |
Number of pages | 16 |
ISBN (Electronic) | 9783319526362 |
ISBN (Print) | 9783319526355 |
DOIs | |
State | Published - Jan 1 2022 |
Keywords
- Clinical trial networks
- Cooperative group clinical trials
- Multicenter clinical trials
- Trial consortiums
ASJC Scopus subject areas
- General Medicine
- General Mathematics