AIDS - What is Surrogate Endpoint

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AIDS - What is Surrogate Endpoint

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1. aids surrogate endpoint

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• CD4 cell count is a weak surrogate endpoint, but has some value as an aid for screening treatments for drug development or preliminary regulatory approval


• Thus, there is interest in knowing how well CD4 cell count performs as a surrogate endpoint, particularly as immune system reconstitution might be important for comparing treatments that reduce HIV RNA levels below assay limits of detection


• The usual approach for validating a surrogate endpoint requires a difference between treatments in clinical outcome that is statistically highly significant []

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