Using genetic testing to improve medication management and reduce adverse drug events

Pharmacogenomic Test Assessment for Medication Management in the Advancement of Medicine

This study is testing if genetic testing can help doctors choose the right medications for patients to reduce side effects and improve how well the drugs work.

Quick facts

• Study type: Observational
• Enrollment: 280000 (estimated)
• Ages: 25 Years and up
• Sex: All
• Sponsor: ClinLogic LLC (Industry-sponsored)
• Locations: 1 site (York, Pennsylvania)
• Trial ID: NCT02738047 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the effectiveness of pharmacogenomic testing in managing medication regimens for patients taking drugs influenced by genetic variations. It involves a multicenter approach to assess how genetic factors can impact drug efficacy and safety. Patients who have undergone pharmacogenomic testing within the last 120 days and have a history of adverse drug events or inadequate drug efficacy will be included in the study. The goal is to identify how personalized medication management can reduce adverse drug events and hospital readmissions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 25 and older who have undergone pharmacogenomic testing and have experienced adverse drug events or inadequate efficacy from their medications.

Not a fit: Patients who are currently hospitalized or do not meet the inclusion criteria related to pharmacogenomic testing will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to safer and more effective medication management for patients based on their genetic profiles.

How similar studies have performed: Other studies have shown promise in using pharmacogenomic testing to improve medication management, indicating a growing body of evidence supporting this approach.

Eligibility 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.

Where this trial is running

York, Pennsylvania

• MD@Home — York, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Haleh Farzanmehr, MD — Gxl
• Study coordinator: Diana Messir

Conditions Pharmacogenomic Testing for Medication Management