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

Right Drug, Right Dose, Right Time - Using Genomic Data to Individualize Treatment (The RIGHT Protocol)

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Diagnostic test: Pharmacogenomic testing

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 Type: Interventional
• Enrollment (Actual): 11098
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Primary cohort; All eligible Biobank participants that receive the majority of their care at Mayo Clinic based on EHR length and depth had pharmacogenomic testing done.	Diagnostic test: Pharmacogenomic testing; A comprehensive PGx interpretive report created by OneOme (www.oneome.com) provides information on how an individual patient's genes may affect medication response. OneOme utilizes algorithms and curated clinical PGx knowledge to generate a highly intuitive personalized report based on a patient's genomic results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Participants - Total number of subjects identified with high risk for being prescribed a PGx drug	Total number of subjects identified with high risk for being prescribed a PGx drug	Baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Suzette Bielinski, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2012
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Personalized Medicine; Pharmacogenomics; Pharmacogenomic Varients
• Other Study ID Numbers: 12-003371

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No