Right Drug, Right Dose, Right Time - Using Genomic Data to Individualize Treatment

Not Applicable

Completed

• Conditions: Healthy Subjects
• Interventions: Diagnostic Test: Pharmacogenomic testing

• Registration Number: NCT03803293
• Lead Sponsor: Mayo Clinic

Brief Summary

This study is being done to better understand how genetic information related to drug dosing and use can affect medical care of patients. By doing this study, the investigators are developing and improving ways to incorporate information about drug related genetic variants into the medical record.

Detailed Description

The purpose of this research is to initiate a test of the concept that sequence information can be coupled to electronic medical records (EMRs) for use in healthcare.The focus of this study is on pharmacogenomics, given the role of adverse drug reactions (ADRs) as major causes of morbidity and mortality, the increasing number of recognized variants included in FDA labels as mediators of both efficacy and toxicity, and the relative lack of stigma attached to carriers of variants in "pharmacogenes". Preemptive sequencing of patients interrogates large numbers of PGx variants and integrates clinically actionable results in a patient's electronic health record (EHR) for use by clinicians at the point-of-care. It is unknown, however, whether integration of preemptive PGx data into the EHR will significantly improve patient outcomes and reduce healthcare costs. Therefore, the Right Drug, Right Dose, Right Time Using Genomic Data to Individualize Treatment Protocol (RIGHT Protocol) study was designed to recruit a large group of patients for preemptive PGx testing, to develop the EHR infrastructure to deliver clinical decision support in real time, and to study the effects of integrating preemptive PGx testing into clinical practice on patient outcomes.

Study Timeline

• Study Start: 2012-07-13
• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-14
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11098

Inclusion Criteria

• Biobank participants who receive the majority of their care at Mayo Clinic based on EHR length and depth.

Exclusion Criteria

• Not in the Mayo Clinic Biobank. Do not receive the majority of their care at a Mayo Clinic site.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Primary cohort	Pharmacogenomic testing	All eligible Biobank participants that receive the majority of their care at Mayo Clinic based on EHR length and depth had pharmacogenomic testing done.

Primary Outcome Measures

Name	Time	Method
Study Participants - Total number of subjects identified with high risk for being prescribed a PGx drug	Baseline	Total number of subjects identified with high risk for being prescribed a PGx drug