Figure 3 Reasons why biomarkers have failed to become surrogate endpoints.

1. Changes in the biomarker reflect the effect of treatment, but these changes are irrelevant to the pathophysiology of the disease indicated (false positive).

2. Changes in the biomarker reflect an effect of treatment on an element of the pathophysiology, but this element is clinically irrelevent (false positive).

3. Changes in the biomarker reflect clinically relevant changes in patho-physiology but do not capture the mechanistic effect of the treatment (false negative).

4. Changes in the biomarker reflect one effect of the treatment, but there are other, more relevent effects on outcome that are not captured (false negative or positive).

5. The biomarker may not correlate well with classical clinical assessors because the biomarker is more sensitive or the classical assessor is irrelevant to a subset of the patient population, a novel mechanism, or a new indication.

It is important to consider this theoretical framework while developing a biomarker or considering biomarkers in decision making. Using more than one biomarker and reviewing the consistency of the data across biomarkers may decrease the risk of making an incorrect conclusion. The classical example of this comes from the osteoporosis field, where BMD alone may provide misleading results, while BMD in combination with other biomarkers of bone metabolism (such as osteocalcin and collagen cross-links) provide a much more robust basis for decision making.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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