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

Mayo Clinic

Status: Completed

Conditions: Healthy Subjects

Treatments: Diagnostic Test: Pharmacogenomic testing

Study type: Interventional

Funder types: Other

Identifiers

NCT03803293

12-003371

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11,098 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11,098 participants in 1 patient group

Primary cohort

Other group

Description:

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

Treatment:

Diagnostic Test: Pharmacogenomic testing