Monitoring Z-values for clinical data interpretation

Details Monitoring Z-values for clinical data interpretation Monitoring Z-values for clinical data interpretation

2007-01-12

2008-11-18

Bui, Bryan (Department: 2863)

Data processing: measuring, calibrating, or testing

Measurement system in a specific environment

Biological or biochemical

Reexamination Certificate

active

07454294

ABSTRACT:
Clinical data that are measured at a plurality of sequential time points are interpreted by monitoring the Z-value of the clinical data. The Z-value of the measured data is calculated at each of the time points. The calculated Z-values are plotted and compared against a pre-selected Z-value, which may be Z=5, in one exemplary embodiment. The clinical data are determined to have undergone a statistically significant change, compared to a baseline value BV of the data, when the calculated Z-value for the measured data is greater than or substantially equal to the pre-selected Z-value. In this way, signal detection from biomarker data may be enhanced. Also, the toxicity level of drugs that are tested in clinical trials may be determined in a more reliable fashion.

REFERENCES:
patent: 2005/0013820 (2005-01-01), Holoshitz et al.
patent: 2008/0026485 (2008-01-01), Hueber et al.

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