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27 - The Role of the Contract Research Organization in Alzheimer’s Disease: The Vital Link in the Clinical Drug-Development Program

from Section 3 - Alzheimer’s Disease Clinical Trials

Published online by Cambridge University Press:  03 March 2022

By
John J. Sramek ,
Henry Riordan ,
Michael F. Murphy  and
Neal R. Cutler
Edited by
Jeffrey Cummings ,
Jefferson Kinney  and
Howard Fillit
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

This chapter reviews the critical role that a contract research organization performs in developing new therapeutics for Alzheimer’s disease (AD).  Late-phase AD trials are lengthy, expensive, and require specialized expertise and experience in order to optimize signal detection.  We review the intricacies of AD protocol design, selection of optimal neuropsychiatric tests for different AD stages, rater training, imaging technologies, and use of biomarkers. Careful planning of trials involves well-thought-out investigator selection, site monitoring, and patient recruitment and retention strategies.  Examples of operational issues in large global trials are also given, including adaptations necessary due to the COVID pandemic.

Keywords

Alzheimer’s DiseaseContract Research OrganizationClinical Drug DevelopmentProtocol DesignInvestigator SitesInvestigator Site MonitoringNeuropsychiatric Rater Training
Type
Chapter
Information
Alzheimer's Disease Drug Development
Research and Development Ecosystem
 , pp. 309 - 318
Publisher: Cambridge University Press
Print publication year: 2022

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References

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