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The study with the most positive conclusions (a significant benefit for treatment interruption in terms of surrogate marker responses) was GIGHAART, which used the shortest interruption time and the highest number of drugs in the new treatment regimen.
Changes in these surrogate markers are usually the study endpoints, and endpoints are the measurements by which a drug's efficacy is judged.
All of this is based on one surrogate marker imaging trial in a
patients experienced prolonged life and delayed disease progression) and this increased comfort levels about using CD4 T cell count as a surrogate marker for approval of future anti-HIV drugs.
MORE investigators selected a number of surrogate markers for increased lifetime exposure to estrogen in the osteoporotic study population and then sought to determine whether raloxifene's cancer-preventing effects were greater in those patients with the most lifetime estrogen exposure.
Without an accepted surrogate marker of some sort, immune treatments have been required to show that they can reduce clinical endpoints.
This report also indicates that almost half of respondents were unable to rate carotid intima-media thickness (CIMT) as being particularly good or bad as a surrogate marker for clinical end points.
CHICAGO -- An assay to calculate circulating tumor cells may be superior to PSA as a surrogate marker for survival in men treated for castration-refractory prostate cancer, according to a study presented at the annual meeting of the American Society of Clinical Oncology.
Low glutathione level appears to be a strong predictor of risk of death in persons with HIV [2] -- but it is not yet known if glutathione level could be a surrogate marker for drug development.
In one study, investigators used Doppler ultrasound to measure common carotid artery intimal-medial wall thickness, a surrogate marker of atherosclerosis, in 80 subjects (Am.
Whether nevus development is directly in the pathway for melanoma development or a surrogate marker for UV-induced skin damage and/or genetic susceptibility to melanoma, our results suggest that tanning avoidance should be considered as a measure for the reduction of melanoma risk in this population.
The FDA based its approval on the results of 3 surrogate marker studies.