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To explore the predictors of intermediate endpoints of cervical cancer in 500 women living in Porto Alegre.
Composite measures comprising patient reported outcomes and intermediate endpoints such as PFS may be the solution and should be investigated further.
These latter measures will provide data on the efficacy of the intervention on intermediate endpoints linked to the primary outcome of interest.
Biomarkers can also be used for early diagnosis of cancer, collecting information on the etiology of the disease, as intermediate endpoints in intervention studies and selection of optimal treatments.
We recommend that basic science and population trials be developed specifically for older hosts with intermediate endpoints of relevance to this group, including cognitive function and trajectories of frailty.
The information extracted from these data has been used in many clinical, epidemiological, and genetic investigations for patient stratification and prognostication, and to determine intermediate endpoints for clinical trials.
The Food and Drug Administration would consider assessments of a device's effect on intermediate endpoints that, when improving in a congruent fashion, are reasonably likely to predict clinical benefit.
However, future studies are necessary to establish the ability of MRI/3D-MRSI to accurately assess patients with premalignant or very early malignant changes, to validate metabolic markers as intermediate endpoints in chemoprevention trials, and to correlate metabolic endpoints with other promising intermediate biomarkers.
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This information can then be used to improve the design of prospective studies, and of clinical intervention trials that use ACF as an intermediate endpoint.
A decline in prostate-specific antigen (PSA) is widely used to monitor treatment response, but is not validated as an intermediate endpoint for overall survival (OS).
Another strategy for increasing the efficiency of breast cancer prevention trials is the validation of intermediate endpoint biomarkers [ 3] to secure validated intermediate endpoint biomarkers (VIEBs).
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