surrogate marker

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surrogate marker

EBM
A parameter (e.g., diastolic blood pressure) used to assess a drug's biological activity, which may serve as indicator of efficacy of a therapeutic agent, rather than a more serious but less common clinical endpoint, such as death.

surrogate marker

Lab medicine A parameter or measured to detect a pathologic condition when a more specific test doesn't exist, is impractical or not cost-effective; surrogate testing has been used for non-A, non-B hepatitis, measuring ALT and antibodies to HBV core antigen–anti-HBc and HC

surrogate marker

An indirect indicator of a disease state or of its response to therapy. Such markers often include laboratory tests thought to represent clinical progress accurately. For example, in diabetes mellitus, the glycosylated hemoglobin level is used as a marker of glycemic control; in AIDS the level of HIV RNA is used as a marker of disease progression.
See also: marker
References in periodicals archive ?
surrogate endpoint generally also requires fewer study subjects to
In MSA and PSP, the absence of surrogate endpoints makes clinical trials even more difficult, long, and expensive.
In this way, once the steady-state and a pharmacological response, ranging between the 20-80% of maximal effect, corresponding to the linear portion of the sigmoid dose-effect curve, is reached, we can estimate the methadone optimal dose, required to achieve its "clinical surrogate endpoint", in absence of other confounder factors for U-T/ Cr ratio (e.g.
The Institute of Medicine's Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease convened a two-day forum in Washington, DC, in June 2010 to provide stakeholders an opportunity to learn about and discuss a report by the committee that evaluated biomarkers in the chronic disease setting in an attempt to make this previously non-uniform evaluation process more consistent.
However, they will not approve a drug on small effect size of a surrogate endpoint (PFS), no matter how good its safety profile.
Zevalin is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naive, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate.
The FDA has indicated that reduction of LDL-cholesterol is an acceptable surrogate endpoint for accelerated approval of mipomersen for use in patients with homozygous familial hypercholesterolemia (hoFH).
The measurement of cholesterol lowering is called a surrogate endpoint, which is different from the measurement of the hard endpoints of decreased heart disease or death.
One interesting point raised by this study is the potential value of DFS as a surrogate endpoint in studies on adjuvant treatment in gastric cancer, which may save time (and lives) for patients (as in colon cancer where DFS is predictive of OS).
The first allows approval to be based on clinical trials that, rather than using standard outcome measures such as survival or disease progression, use "a surrogate endpoint that is reasonably likely ...