It is a short guidance at 8 pages but does frame the issues the Agency is most interested in.
As part of the announcement the FDA notes <https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-guidance-regarding-drug-development-early-alzheimers-disease>:
"Drug developers considering the use of a surrogate endpoint as the primary measure of effect should discuss their plans with FDA early in development. The agency strongly supports and encourages continued research in understanding the role of surrogate endpoints and stresses their potential importance in the successful development of effective treatments for the earliest stages of Alzheimer's disease."
The guidance itself describes 6 stages of Alzheimer's but the focus of this guidance is only for the early stages (1-3). Under Outcomes Measures, it discusses 1) Clinical Endpoints, 2) Time-to-Events Analysis, 3) Surrogate Endpoints and 4) Considerations for Specific Stages of Early AD.
It can be downloaded here: https://www.fda.gov/media/110903/download
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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