Impact of non‐binding FDA guidances on primary endpoint selection in Alzheimer's disease trials

Impact of non‐binding FDA guidances on primary endpoint selection in Alzheimer's disease trials

Abstract Introduction The U.S. Food and Drug Administration (FDA)'s guidances help describe the agency's current thinking on regulatory issues and serve as a means of informal policymaking that is non‐binding. This study examines the impact of two guidance documents for Alzheimer's di...

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Bibliographic Details
Main Authors: Jeffrey C. Yu, Jakub P. Hlávka, Elizabeth Joe, Frances J. Richmond, Darius N. Lakdawalla
Format: Article
Language:English
Published: Wiley 2022-01-01
Series:Alzheimer’s & Dementia: Translational Research & Clinical Interventions
Subjects:
Alzheimer's disease
Clinical Dementia Rating Sum of Boxes
clinical trials
composite endpoints
Food and Drug Administration
guidance documents
Online Access:https://doi.org/10.1002/trc2.12280

Internet

https://doi.org/10.1002/trc2.12280

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