In an adverse events review, what is the clinical significance of laboratory values means?
CHP: the “mean” laboratory value has no meaning or place in an AE review. Laboratory values are looked at individually. It is conceivable for a study that the “mean” was within the reference range yet some were quite a bit beyond the reference range upper limit. This is a PI decision. The only case I can conceive where means values were asked for was laziness of the person requesting the “mean”.
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- In an adverse events review, what is the clinical significance of laboratory values means?
