German Journal for Evidence and Quality in Health Care

Volume 106, Issue 3, 00-2012

pp. 161-167 (7)

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Gerd Glaeske

Summary

Surrogate markers are only acceptable in single exceptional cases to demonstrate a patient related true outcome in medical care. This is especially true in drug therapy. Although many surrogate markers are correlated with an outcome, only a few have been shown to capture the effect of a treatment on the outcome. The examples for aberrations in medical care are numerous: They include menopausal hormone therapy, the prevention of cancer or cardiovascular diseases with vitamins, the therapy of cardiac arrhythmias using a special type of drugs as well as the treatment of osteoporosis with fluoride. All these treatments caused more harm than good to the patients; and very often mortality increased. In summary, most of the surrogate markers are not worth discussing, and they should not be utilised to demonstrate patient related outcome; they may only be acceptable in rare cases and would then have to be rigorously validated to protect patients from harm.

(As supplied by publisher)

Keywords

Surrogatparameter; Surrogatendpunkte; Validierung; patientenorientierter Nutzen; Nutzen-Schaden-Relation; Onkologie; surrogate markers; surrogate end points; validation; patient oriented effectiveness; benefit-harm ratio; oncology

DOI (Digital Object Identifier):   10.1016/j.zefq.2012.03.012