Utility of PharmacoGenomics for Reducing Adverse Drug Effects

Study Overview
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Brief Summary
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UPGRADE aims to see whether data from Pharmacogenomic Testing (PGx) can help physicians manage patient medication regimens and assess if the testing has an effect on reducing adverse drug reactions, hospitalizations and emergency department visits. The way an individual processes a drug is in part determined by their genes, and there is known to be genetic variation between humans in the way drugs are metabolized. The study of the way genes affect a person's response to drugs is known as Pharmacogenomics.

Official Title
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Utility of PharmacoGenomics for Reducing Adverse Drug Effects

Conditions
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Genetics of Drug Metabolism

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject plans to undergo current index PGx testing at the time of enrollment or underwent current index PGx testing within the prior 1-year period, for genes known to influence metabolism of at least one target drug Subject is aged ≥18 years Subject is able and willing to provide written informed consent Subject reveals a history of at least one TDAE or an inadequate therapeutic effect from a target drug over the 12-month period preceding expected receipt of PGx test results Subject is not taking an investigational medication or in an interventional trial that would interfere with participation in the registry Exclusion Criteria: Subject is currently hospitalized Subject's medical and medication history is unavailable over the 90-day periods preceding and following the receipt of pharmacogenomic test results Subject is unable to provide an accurate history due to mental incapacity Subject is known to have undergone prior pharmacogenomic testing (exclusive of the current index PGx testing) for genes specific to the target drugs within the 2-year period preceding enrollment and these results have been previously evaluated

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Meaningful Change in Drug Regimen | The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined for each subject as: A genotype known to affect a target drug is identified by PGx testing, AND The treating physician makes at least one target drug regimen change in dose, frequency, or route of administration, or when target drug discontinuation or substitutions occur. | 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in target drug regimen over the 90-day period preceding receipt of PGx results, compared to the changes made in the 90-day period thereafter |  | 90 days | 
| Number of Target Drug-Related Adverse events (TDAE) over the 90-day period preceding receipt of PGx test results compared with the number over the 90-day period after the test |  | 90 days | 
| Target-drug related outpatient clinic visits, emergency department visits, and hospitalizations over the 90-day period prior to the receipt of PGx test results, compared to the number of visits over the 90-day period following testing. |  | 90 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacogenomics, Target Drug Related Adverse Events (TDAE)