Monitoring Z-values for clinical data interpretation
OwnerGordon F. Kapkeinventor
Life of this patent
Estimating the term…
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.
Claims18
A method of interpreting clinical data measured at a plurality of time points, the method comprising:
- monitoring the Z-values of the data by calculating for each time point a Z-value of the data measured at that time point, and comparing the calculated Z-value against a pre-selected Z-value;
- and
- identifying a statistically significant change in the clinical data as compared to a BV (baseline value), when the calculated Z-value is greater than, or substantially equal to, the pre-selected Z-value,
- wherein the act of calculating the Z-value of the data for each time point comprising calculating the Z-value in terms of a reference change value RCV of the data, and
- wherein the reference change value RCV at a time point is given as a percentage by:
- RCV=100*[(baseline value BV)−(data measured at that time point)]/(baseline value BV).
A method of interpreting clinical data measured at a plurality of time points, the method comprising:
- monitoring Z-value of the data by calculating for each time point a Z-value of the data measured at that time point, and comparing the calculated Z-value against a pre-selected Z-value;
- and
- identifying a statistically significant change in the clinical data as compared to a baseline value BV, when the calculated Z-value is greater than, or substantially equal to, the pre-selected Z-value,
- wherein the Z-value at each time point is given by:
- Z
- =
-
- (
- RCV
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- 2
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- CV
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- =
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- 100
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- BV
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- value
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- individuals
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- CV
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- ,
- where RCV represents a reference change value defined as a difference between two test results in an individual that is statistically significant in a given proportion of the plurality of individuals,
- where CVA represents analytic precision of the data,
- where CVI represents intra-individual biological variability of the data, and
- where CVA and CVI are in percent.
A method of enhancing signal detection from biomarker data, the method comprising:
- measuring the biomarker data at each one of a plurality of sequential time points;
- calculating, for each time point, a Z-value of the data measured at that time point;
- and
- comparing the calculated Z-value against a pre-selected Z-value to determine whether magnitude of signal detected from the biomarker data is clinically significant;
- wherein the biomarker data comprise data relating to concentration within the individuals of an analyte;
- and
- wherein the act of comparing the calculated Z-value against the pre-selected Z-value comprises plotting the Z-values calculated at each time point against the concentration of the analyte.
A method of assessing toxicity level of at least one drug for a plurality of individuals, the method comprising:
- administering the drug to the individuals;
- measuring, at a plurality of sequential time points, concentration of an analyte within the individuals, wherein the concentration of the analyte is affected by the amount of the drug that is administered;
- monitoring the Z-values of the measured concentration, by calculating for each time point a Z-value of the analyte concentration as measured at that time point and comparing the calculated Z-value against a pre-selected Z-value, wherein the pre-selected Z-value is indicative of a change in the measured concentration, with respect to a baseline value BV, that signals a toxic level reached by the administered drug.
An apparatus for interpreting clinical data measured at a plurality of time points, the apparatus comprising:
- a processing system configured to the monitor Z-values of the clinical data by calculating at each time point the Z-value for the data measured at that time point, the processing system further configured to compare the calculated Z-value against a pre-selected Z-value, and to identify a statistically significant change in the clinical data compared to a baseline value BV of the data, when the calculated Z-value is substantially equal to the pre-selected Z-value.
Dependencies are inferred from the claim text.