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OpenTrials
Completed

NCT Number: NCT03803293

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmacogenomic testing

Diagnostic Test

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.

Primary outcomes

  1. Study Participants - Total number of subjects identified with high risk for being prescribed a PGx drug

    Time frame: Baseline

    Total number of subjects identified with high risk for being prescribed a PGx drug

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Jan 14, 2019
Registry last updated
Oct 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.