EACs: When and Why?
Find out more with the informative white paper: A “Second Opinion” for Subjective Endpoints: The Case for an Endpoint Assessment Committee
For many of today’s trials, the primary endpoint is a subjective assessment and depends on physician-rated or even patient-reported data, which means validation to the FDA and other regulatory agencies is automatically more difficult. For registration trials with subjective endpoints, blinded independent central review (BICR) of the trial data – including both images and other data such as laboratory and pathology data, autopsy reports, and physical descriptions – can be extremely valuable and may be executed through an endpoint assessment committee (EAC).
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