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This trial includes patients whose sentinel node is positive only by reverse-transcriptase polymerase chain reaction (RT-PCR), a technique that has not been validated as predictive of worse survival or of increased risk of nonsentinel node metastasis.
However, as very few of these genes have been validated as predictive biomarkers so far, it is mostly conventional clinical and pathological factors that are being used as prognostic indicators of clinical course.
There is increasing use of surrogate endpoints that have not been validated as predictive of improvement in duration or quality of survival (Booth et al, 2008; Kay et al, 2012) and growing recognition that RCTs underestimate and under-report harms from new cancer therapies (Seruga et al, 2011; Niraula et al, 2012).
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The EORTC and CALGB prognostic groups were validated as predictive for OS (HR 1.62; P<0.001 and HR 1.65; P<0.001, respectively).
Risk or vulnerability factors (or their reciprocals, measuring the absence of risk) and protective or resilience factors can be validated as predictive or not using the receiver operating characteristic, as a means of taking into account base rate variations between samples [ 28].
This classification has been validated as having predictive value for TBI outcome as well [ 4- 7].
The interactive thresholding technique introduced by Byng et al. [ 8], Cumulus, has been validated as being predictive of breast cancer risk in many large epidemiologic studies, and has thus gained acceptance as the gold standard for acquiring quantitative MD reads.
Volpara shows good agreement with breast magnetic resonance imaging (MRI) data [ 11] and its measures (percent and absolute dense volume) have been validated as being predictive of breast cancer risk [ 12, 13].
Biomarker 1 is considered to be a gold standard that has previously been validated as a predictive biomarker (i.e., the treatment effect of the treatment being investigated depends on the biomarker value) with biomarker 2 a cheaper potential alternative.
(Ravaud, 2011) Hypertension was once considered a potential indicator for efficacy of anti-VEGF therapy but it has not been validated as a predictive marker and a recent meta-analysis showed no association (Hurwitz et al, 2013).
122 However, thus far no genomic signature has been validated as a predictive marker for use in metastatic CRC, in part due to the retrospective, heterogeneous, and/or small nature of studies attempting to derive these signatures.
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CEO of Professional Science Editing for Scientists @ prosciediting.com