Pharmacogenetic Testing for Medication Management.

Medication Interactions to Detect Adverse Situations

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.

Study Overview

• Status: Withdrawn
• Conditions: Medication Management
• Intervention / Treatment: Other: Observational study, data collection only trial.

Detailed Description

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Patient underwent PGx testing for alleles appropriate to the target drugs within the prior 90 days ("index PGx test");
2. Male or female patients 18 years or older who have given their written Informed Consent to participate in a Clinical Study based on voluntary agreement a through explanation of the patient's participation is provided to them. Patients must have adequate reading and writing abilities such that they can comprehend and answer the questions on the patient- completed assessments and Informed Consent Form;
3. Patient was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test), including over-the-counter medications;

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:

1. Patient is currently hospitalized;
2. Patient's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx testing;
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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No treatment.; Data collection only trial design.	Other: Observational study, data collection only trial.; Data collection only trial design.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: First Vitals LLC
• Investigators: Study Director: Ernie Lee, CHRS, First Vitals LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: September 22, 2015
• First Submitted That Met QC Criteria: September 22, 2015
• First Posted (Estimate): September 24, 2015

Study Record Updates

• Last Update Posted (Actual): August 1, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: MIDAS