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23 - Globalization of Alzheimer’s Disease Clinical Trials

from Section 3 - Alzheimer’s Disease Clinical Trials

Published online by Cambridge University Press:  03 March 2022

Jeffrey Cummings
Affiliation:
University of Nevada, Las Vegas
Jefferson Kinney
Affiliation:
University of Nevada, Las Vegas
Howard Fillit
Affiliation:
Alzheimer’s Drug Discovery Foundation
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Summary

Globalization in clinical trials for Alzheimer’s disease (AD) drug development has increased rapidly. It would substantially support persons with dementia to access novel therapeutics in a coordinated and efficient manner. In this chapter, we overview the significant drives of globalization in AD drug development: the growth of the world’s AD population, the need for a larger sample in trials to secure enrollment in the required timeframe, and the ethnographic and ethnobiological contributors. We also discuss the major issues relevant to global trials: the geographic variation across trial sites, the differences in study participants, and the lack of harmonized global regulatory mechanisms. In the end, this chapter recommends that improving site performance, enhancing infrastructure development, and promoting universal regulatory mechanism should be prioritized to maximize the contribution of globalization to the AD drug development ecosystem.

Type
Chapter
Information
Alzheimer's Disease Drug Development
Research and Development Ecosystem
, pp. 275 - 280
Publisher: Cambridge University Press
Print publication year: 2022

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