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

Pharmacogenomic Test Assessment for Medication Management in the Advancement of Medicine

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

Study Overview

• Status: Recruiting
• Conditions: Pharmacogenomic Testing for Medication Management

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 280000

Contacts and Locations

• Study Contact: Name: Diana Messir; Phone Number: 239-908-0412; Email: Diana@integritycro.com
• Study Contact Backup: Name: Diana M Messir; Phone Number: 239-908-0412; Email: Diana.M@Radar-PGxStudy.com

Study Locations

• United States
  • Pennsylvania
    • York, Pennsylvania, United States, 17402
      • Recruiting
      • MD@Home
      • Contact: Marv Inscore; Phone Number: 717-840-8686

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients who are under treatment with several drugs with any of the sequences of biochemical reactions, catalyzed by enzymes, known to be influenced by genetic variation in a patient population.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radar, Pharmocogenomic	The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each patient when: A genotype known to affect a drug the patient is taking is identified, *and*; The patient's treating physician makes at least one target drug regimen change, dose, substitution, or discontinuation. Change in drug dose, substitution, or discontinuation among patients with an identified genotype known to affect a drug the patient is taking as directed. This will be assessed by a quantitative survey.	The period of enrollment is anticipated to be 36 months with a 120- day follow-up period, for total study duration of approximately 40 months from first patient enrolled to completion of follow-up on the last patient in.

Collaborators and Investigators

• Sponsor: ClinLogic LLC
• Investigators: Principal Investigator: Haleh Farzanmehr, MD, GXL; Study Director: Haleh Farzanmehr, MD, GXL

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 28, 2016
• First Submitted That Met QC Criteria: April 8, 2016
• First Posted (Estimated): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 10202016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED