Table 3.
Factor | Questions |
---|---|
Patient or population | Is the variant likely relevant in the patient or population? |
How common is the variant? | |
Quality of evidence | What is the strength of the evidence for the use of data? |
Are clinical guidelines or FDA recommendations available? | |
Testing | Is testing available? |
Is the coverage appropriate? | |
What is the turnaround time of results? | |
Data availability | Does pharmacogenomics data already exist? |
Is the data quality sufficient to use? | |
Drug factors | How important is the gene/variant for the pharmacokinetics or pharmacodynamics of the drug? |
Does the drug have a narrow therapeutic index? | |
Is the drug a prodrug or active? | |
Will the variant decrease efficacy and/or increase toxicity? | |
Clinical factors | Are there other factors relevant to the decision, like timing of drug start or previous use of the medication? |
How do comorbid clinical conditions affect expected phenotypes? | |
Are there drug-drug interactions that affect expected phenotypes? |
FDA, Food and Drug Administration.