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

Abstract

A method for assessing and analyzing one or more drugs, adverse effects and associated risks, and patient characteristics resulting from the use of at least drug of interest is disclosed. The method comprises the steps of selecting one or more cases for analysis, said cases describing the behavior between at least one drug of interest and a patient genotype; profiling statistically derived values from multiple cases related to the safety of the at least one drug, wherein at least one filter is employed for deriving said values; at least one data mining engine; and an output device for displaying the analytic results from the data mining engine. A system for performing the method is likewise disclosed.

1 . A computer-assisted method for identifying associations between administration of one or more drugs, adverse drug reactions reported for such drugs, and genotypes of persons having taken such drugs and having suffered such adverse reactions, comprising the steps of:
 (a) accessing, by a computer program, a relational database containing drug information, adverse drug effects reportedly suffered by patients to whom drugs have been administered, and genetic information of such patients;   (b) receiving by a computer program a user-selected variable for analysis, said variable selected from the group consisting of a drug, an adverse effect, and a patient genotype;   (c) retrieving, from said relational database, information corresponding to said selected variable;   (d) statistically analyzing, using statistical analysis software, occurrences of adverse effects associated with administration of a drug against genotypes of patients to whom the drug has been administered to find statistical correlations between adverse effects associated with the administration of a drug and a genotype; and   (e) displaying the analytic results through an output device.   
     
     
         2 . The method of  claim 1 , wherein statistically analyzing comprises correlating or proportionally comparing adverse effects and patient geneotypes. 
     
     
         3 . The method of  claim 1 , wherein the data is cleaned, wherein cleaning comprises removal of noise, spell checking, and removal of redundant entries. 
     
     
         4 . The method of  claim 1 , wherein the relational database comprises stored data which is mapped to tokens, wherein a token comprises a standardized search term. 
     
     
         5 . The method of  claim 4  wherein a token is selected from the group of reference sources consisting of MEDRA, WHO Drug Directories, FDA Orange Book, COSTART, NDCD,GPRD and WHOART. 
     
     
         6 . The method of  claim 1 , wherein steps (a)-(e) are performed in a network environment. 
     
     
         7 . (canceled) 
     
     
         8 . The method of  claim 1 , wherein the statistical analysis is performed using a correlator, a proportional analysis engine, or a comparator. 
     
     
         9 . A system for identifying associations between one or more drugs, adverse drug reactions reported for such drugs, and genotypes of persons having taken such drugs and having suffered such adverse drug reactions, comprising:
 (a) a selector for selecting one or more variables for analysis, the one or more variables selected from the group consisting of a drug, an adverse drug effect, and a patient genotype;   (b) an analysis engine for statistically analyzing, based on data stored in a relational database, occurrences of adverse effects associated with administration of a drug against genotypes of patients to whom the drug has been administered; and;   (c)   (c) an output device for displaying the analytic results from the engine.   
     
     
         10 . The system of  claim 9 , wherein said analysis engine is configured to correlate or compare adverse effects and patient genotypes. 
     
     
         11 . (canceled) 
     
     
         12 . The system of  claim 9 , wherein the relational database comprises stored data which is mapped to tokens, wherein a token comprises a standardized search term. 
     
     
         13 - 16 . (canceled)