Genetics of Drug Metabolism
Conditions
Keywords
Pharmacogenomics, Target Drug Related Adverse Events (TDAE)
Brief summary
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.
Interventions
None listed
Sponsors
Companion Dx Reference Lab, LLC
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Meaningful Change in Drug Regimen | 90 Days | 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. |
Secondary
| Measure | 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 |
Countries
United States
Contacts
Primary ContactStudy Coordinator
Outcome results
None listed