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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT03803293

Collaborator

(none)

11,098

Enrollment

Arm

89.6

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Diagnostic Test: Pharmacogenomic testing	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

11098 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The Mayo Clinic Biobank is an institutional resource comprised of adult community volunteers who donated biological specimens, provided risk factor data, access to EHR data, and consented to participate in additional studies. Subjects in the Mayo Clinic Biobank are the cohort that was recruited to participate in the RIGHT study.The Mayo Clinic Biobank is an institutional resource comprised of adult community volunteers who donated biological specimens, provided risk factor data, access to EHR data, and consented to participate in additional studies. Subjects in the Mayo Clinic Biobank are the cohort that was recruited to participate in the RIGHT study.

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 13, 2012

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Suzette Bielinski, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Suzette J. Bielinski, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT03803293

Other Study ID Numbers:

12-003371

First Posted:

Jan 14, 2019

Last Update Posted:

Oct 7, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Suzette J. Bielinski, Principal Investigator, Mayo Clinic

Pharmacogenomics

Personalized Medicine

Pharmacogenomic Varients

Study Results

No Results Posted as of Oct 7, 2021