Criteria to establish clinical utility of predictive biomarker
| Domains . | Criteria . | Questions to be answered . | Specific comments . |
|---|---|---|---|
| Technical efficacy | 1. Analytical validity | Does the test measure the biomarker reliably? | |
| 2. Biological validity | Does the test measure a variable that is uniquely related to either the pharmacokinetics or pharmacodynamics of clopidogrel? | Does the phenotypic test measure the inhibitory effect of clopidogrel on ADP-induced platelet activation? | |
| Does the genetic test predict reduced (or increased) concentrations of active clopidogrel metabolite? | |||
| 3. Clinical validity | Does the biomarker predict clinical state reliably and accurately? | The test predicts greater or less clinical benefit or harm with clopidogrel in appropriately designed studies with a sufficient number of predicted outcomes to draw reliable, meaningful conclusions. | |
| Therapeutic efficacy | 4. Clinical utility | (A) Does measurement of the biomarker and tailoring therapy according to biomarker improve patient outcome? | If the test is predictive of less benefit or more harm, there is a strategy available that improves clinical outcome; either changing (increasing or decreasing) dose or using a different agent in patient identified as hypo- or hyper-responders by the test. |
| (B) Comparative efficacy: Does a biomarker-based strategy improve clinical outcome compared with newer therapy (prasugrel, ticagrelor, or higher-dose clopidogrel)? | When the test is used to guide patient decisions about the use of the treatment strategy that improves patient outcomes, the benefits are greater than if the test is not used. (Otherwise simply use the strategy without testing). |
| Domains . | Criteria . | Questions to be answered . | Specific comments . |
|---|---|---|---|
| Technical efficacy | 1. Analytical validity | Does the test measure the biomarker reliably? | |
| 2. Biological validity | Does the test measure a variable that is uniquely related to either the pharmacokinetics or pharmacodynamics of clopidogrel? | Does the phenotypic test measure the inhibitory effect of clopidogrel on ADP-induced platelet activation? | |
| Does the genetic test predict reduced (or increased) concentrations of active clopidogrel metabolite? | |||
| 3. Clinical validity | Does the biomarker predict clinical state reliably and accurately? | The test predicts greater or less clinical benefit or harm with clopidogrel in appropriately designed studies with a sufficient number of predicted outcomes to draw reliable, meaningful conclusions. | |
| Therapeutic efficacy | 4. Clinical utility | (A) Does measurement of the biomarker and tailoring therapy according to biomarker improve patient outcome? | If the test is predictive of less benefit or more harm, there is a strategy available that improves clinical outcome; either changing (increasing or decreasing) dose or using a different agent in patient identified as hypo- or hyper-responders by the test. |
| (B) Comparative efficacy: Does a biomarker-based strategy improve clinical outcome compared with newer therapy (prasugrel, ticagrelor, or higher-dose clopidogrel)? | When the test is used to guide patient decisions about the use of the treatment strategy that improves patient outcomes, the benefits are greater than if the test is not used. (Otherwise simply use the strategy without testing). |