<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03803293</url>
  </required_header>
  <id_info>
    <org_study_id>12-003371</org_study_id>
    <nct_id>NCT03803293</nct_id>
  </id_info>
  <brief_title>Right Drug, Right Dose, Right Time - Using Genomic Data to Individualize Treatment</brief_title>
  <official_title>Right Drug, Right Dose, Right Time - Using Genomic Data to Individualize Treatment (The RIGHT Protocol)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to better understand how genetic information related to drug dosing&#xD;
      and use can affect medical care of patients. By doing this study, the investigators are&#xD;
      developing and improving ways to incorporate information about drug related genetic variants&#xD;
      into the medical record.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research is to initiate a test of the concept that sequence information&#xD;
      can be coupled to electronic medical records (EMRs) for use in healthcare.The focus of this&#xD;
      study is on pharmacogenomics, given the role of adverse drug reactions (ADRs) as major causes&#xD;
      of morbidity and mortality, the increasing number of recognized variants included in FDA&#xD;
      labels as mediators of both efficacy and toxicity, and the relative lack of stigma attached&#xD;
      to carriers of variants in &quot;pharmacogenes&quot;. Preemptive sequencing of patients interrogates&#xD;
      large numbers of PGx variants and integrates clinically actionable results in a patient's&#xD;
      electronic health record (EHR) for use by clinicians at the point-of-care. It is unknown,&#xD;
      however, whether integration of preemptive PGx data into the EHR will significantly improve&#xD;
      patient outcomes and reduce healthcare costs. Therefore, the Right Drug, Right Dose, Right&#xD;
      Time Using Genomic Data to Individualize Treatment Protocol (RIGHT Protocol) study was&#xD;
      designed to recruit a large group of patients for preemptive PGx testing, to develop the EHR&#xD;
      infrastructure to deliver clinical decision support in real time, and to study the effects of&#xD;
      integrating preemptive PGx testing into clinical practice on patient outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2012</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Study Participants - Total number of subjects identified with high risk for being prescribed a PGx drug</measure>
    <time_frame>Baseline</time_frame>
    <description>Total number of subjects identified with high risk for being prescribed a PGx drug</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11098</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Primary cohort</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pharmacogenomic testing</intervention_name>
    <description>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.</description>
    <arm_group_label>Primary cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biobank participants who receive the majority of their care at Mayo Clinic based on&#xD;
             EHR length and depth.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not in the Mayo Clinic Biobank. Do not receive the majority of their care at a Mayo&#xD;
             Clinic site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suzette Bielinski, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>October 6, 2021</last_update_submitted>
  <last_update_submitted_qc>October 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Suzette J. Bielinski</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Pharmacogenomics</keyword>
  <keyword>Personalized Medicine</keyword>
  <keyword>Pharmacogenomic Varients</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03803293
org study id: 12-003371
nct id: NCT03803293
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
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.
primary purpose: Basic Science
masking: None (Open Label)
measure: Study Participants - Total number of subjects identified with high risk for being prescribed a PGx drug
time frame: Baseline
description: Total number of subjects identified with high risk for being prescribed a PGx drug
arm group label: Primary cohort
arm group type: Other
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.
intervention type: Diagnostic Test
intervention name: Pharmacogenomic testing
description: 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 group label: Primary cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Suzette Bielinski, PhD
role: Principal Investigator
affiliation: Mayo Clinic
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Suzette J. Bielinski
investigator title: Principal Investigator
sharing ipd: No