Reduction of Adverse Drug Events and Readmissions (RADAR-PGX)

ClinLogic

Status: Enrolling

Conditions: Pharmacogenomic Testing for Medication Management

Study type: Observational

Funder types: Industry

Identifiers

NCT02738047

10202016

Details and patient eligibility

About

Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known with genetic variation.

Full description

Pharmocogenomic. A multicenter, observational study to evaluate the use of a Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known to be influenced by genetic variation.

Enrollment: 280,000 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

Patients may be included in the Study if they meet all of the following inclusion criteria:

1. Male or female patients of 25 years of age or older who are able to give their written Informed Consent to participate in a Clinical Study based on voluntary agreement with a thorough explanation of the patient's participation will be provided to them.
2. Patient underwent PGx testing for alleles appropriate to the target drugs within the prior 120 days ("index PGx test assessment");
3. Patient was receiving at least one medication known to be associated with allelic variation at the time of the ("index PGx test assessment"), including over-the- counter medications;
4. Patient has a history of at least one TDAE over the 24-month period preceding the PGx test assessment, or has experienced inadequate efficacy from a target drug.

EXCLUSION CRITERIA

Patients will be excluded from the Study if any of the following criteria apply:

1. Patient is currently hospitalized;
2. Patient's medical and medication history is unavailable over the 120-day period preceding the PGx test assessment;
3. Patient is unable to provide an accurate history due to mental Incapacity;
4. Patient is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Study.