What type of biomarker was measured?
As discussed above, when the study does not measure disease incidence or associated mortality, then surrogate endpoints are essential for measuring risk. Scientific conclusions cannot be drawn about the relationship between the substance and risk of the disease if the risk biomarker is not a surrogate endpoint (see discussion above in Section III.C). The agency does not intend to use such studies from which scientific conclusions cannot be drawn in its evaluation of the substance/disease relationship. • How long was the study conducted? Studies that use a surrogate endpoint should be conducted long enough to ensure that any change in the endpoint is in response to the dietary intervention. If the study is run for a short time period such that the effects of the substance cannot be evaluated, then scientific conclusions cannot be drawn about the relationship between the substance and the disease and, therefore, the agency does not intend to use such a study to evaluate the substance/dis
