Claim chart US 7461006

Prior-art evidence dossier

US 7461006 · 2002-08-28

Method and system for the analysis and association of patient-specific and population-based genomic data with drug safety adverse event data

Surfaced at depth 1,971 of 100,104 eligible references. Of 11 limitations, 9 are taught by this reference and 2 are taught in substance with narrower claim wording.

1(pre)

1. A computer-implemented method of evaluating outcomes, comprising:

taught by this reference

A method for assessing and analyzing one or more drugs, adverse effects and associated risks, and patient information resulting from the use of at least one drug of interest, comprising:

The reference discloses a method for assessing and analyzing drugs, adverse effects, and patient information, which constitutes a computer-implemented method of evaluating outcomes.

1(a)

identifying a patient care-related outcome of interest;

taught by this reference

adverse effects relating to drugs

The reference identifies adverse effects relating to drugs, which represents identifying a patient care-related outcome of interest.

1(b)

extracting electronic clinical data associated with historical healthcare encounters for a plurality of patients, by:

taught by this reference

collecting data from a plurality of sources comprising drug information, adverse effects relating to drugs and patient information; placing collected data into a data structure, wherein data from sources not already in a relational database structure are parsed into a relational database structure; generating a relational database for relating drug information, adverse effects and patient information; assembling said patient information, drug information and adverse effects into individual cases, wherein each said case contains patient information, information related to a drug administered to that patient and a description of an adverse drug reaction;

The reference teaches collecting and parsing patient information, drug information, and adverse drug reactions from multiple sources into individual cases in a relational database, which corresponds to extracting electronic clinical data associated with historical healthcare encounters for a plurality of patients.

1(c)

deriving at least one model based upon model variables that have a clinical and/or statistical significance to the outcome of interest the at least one model selected from:

taught by this reference

using said relational database to conduct statistical analysis across a set of cases to determine whether there is an indication of association among a drug, a reaction or group of reactions and a genotype and the distribution of that association in a population; creating a profile comprising the results of said statistical analysis that describes the behavior of the drug of interest based on patient genotype from multiple cases related to the safety of the at least one drug, wherein one or more filters is employed to select among available variables to permit recalculation of the statistical analysis;

The reference teaches conducting statistical analysis across cases to determine associations between drugs, reactions, and genotypes, and creating profiles based on variables/filters, which corresponds to deriving a model based upon model variables that have clinical/statistical significance to the outcome of interest.

1(d)

determining patient groups among the plurality of patients for which electronic clinical data is extracted, with the aid of a computer processor that executes a program, by:

taught by this reference

wherein the analysis of the data collected involves parsing a population segment data into a plurality of population segments, the population segments having differing rates of metabolism;

The reference teaches parsing population segment data into a plurality of population segments with differing rates of metabolism, which corresponds to determining patient groups among the plurality of patients.

1(e)

deriving a hypothesized etiological explanation for why one or more patient groups have different likelihoods of the outcome of interest, consequences associated with the outcome of interest or both, when compared to other defined patient groups, by comparing defined patient groups and identifying different likelihoods of the outcome of interest;

taught by this reference

predicting, in a first state, how the drug interactions or the genotype interactions increase a likelihood for one or more adverse reactions; and predicting, in a second state, how the drug interactions or the genotype interactions or decrease a likelihood for one or more adverse reactions.

The reference teaches predicting how drug or genotype interactions increase or decrease the likelihood of adverse reactions, which corresponds to deriving a hypothesized explanation for why patient groups have different likelihoods of the outcome of interest.

1(f)

identifying at least one physiological process associated with the derived hypothesized etiological explanation;

taught by this reference

wherein the drug of interest is analyzed using two or more metabolic pathways; wherein a first metabolic pathway includes the parsed population segment data relating to population segments having differing rates of metabolism; wherein a second metabolic pathway includes the parsed drug safety data relating to drug safety data based on a genomic perspective; wherein the first and the second metabolic pathways are assimilated; and wherein the first and the second metabolic pathways are correlated.

The reference identifies metabolic pathways (physiological processes) associated with the population segments and genomic perspectives used to analyze the drug safety and adverse reactions.

1(g)

outputting a clinical intervention based upon the identified physiological process;

taught by this reference

changing a variable; determining whether the variable change affects the patient's safety; determining whether the variable change affects an efficacy of the drug; and displaying one or more results of the variable change, wherein the variable change comprises changing a drug dosage for the drug of interest.

The reference teaches changing a drug dosage for the drug of interest, which is a clinical intervention based upon the identified physiological process (metabolic pathways).

1(h)

selecting the clinical intervention for a select patient group wherein the identified clinical intervention is directed to decrease the likelihood of the adverse outcome of interest or decrease the consequences of the adverse outcome of interest, or both, for the select patient group; and

substance taught, wording narrower

The reference teaches changing a drug dosage (clinical intervention) to affect patient safety and efficacy (decreasing adverse outcomes) for patients with specific genotypes or metabolic rates, but does not use the exact phrasing of selecting the clinical intervention for a select patient group to decrease the likelihood of the adverse outcome.

1(i)

verifying the effectiveness of the selected clinical intervention by:

taught by this reference

determining whether the variable change affects the patient's safety; determining whether the variable change affects an efficacy of the drug;

The reference teaches determining whether the variable change (the clinical intervention) affects the patient's safety and drug efficacy, which corresponds to verifying the effectiveness of the selected clinical intervention.

1(j)

modifying the selected clinical intervention based upon the determined likelihood of outcome of interest for the generated patient group.

substance taught, wording narrower

The reference teaches modifying the clinical intervention (changing a drug dosage) based on determining whether the change affects the patient's safety and efficacy (likelihood of outcome of interest).