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Loss of funding for the continuation of the Study
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The Study is a single-arm prospective trial of patients receiving at least one medication with a known association between genetics and drug metabolism. All patients will undergo genetic testing as determined by their treating physician. The specific genes tested will, in general, be based upon the drugs the patients are taking or those that the patient's treating physician is considering as potential substitutes for current medications.
In this data collection only trial design, the PGx test is not a protocol-specified procedure. Rather, patients are eligible if they have undergone PGx testing within the last 90 days. Thus, PGx testing will not be performed solely for inclusion in this clinical research initiative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No treatment. | Data collection only trial design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study, data collection only trial. | Other | Data collection only trial design. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of the Study is the binary occurrence of meaningful change in drug regimen. | 90-day period following receipt of PGx test results |
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Inclusion Criteria:
5. Patient has a history of at least one TDAE over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug and receiving medical coverage through a private insurance.
Exclusion Criteria:
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The Study will include male or female patients 18 years of or older who are receiving at least one medication with metabolism known to depend on genetic variation and have the PGx test already performed. The patient must also meet the inclusion/ exclusion criteria established by the protocol.
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| Name | Affiliation | Role |
|---|---|---|
| Ernie Lee, CHRS | First Vitals LLC | Study Director |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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