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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
- By John J. Sramek, Henry Riordan, Michael F. Murphy, Neal R. Cutler
Edited by Jeffrey Cummings, University of Nevada, Las Vegas, Jefferson Kinney, University of Nevada, Las Vegas, Howard Fillit
Book:

Alzheimer's Disease Drug Development

Published online:

03 March 2022

Print publication:

31 March 2022, pp 309-318
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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.