Clinical trial NCT03803293: Right Drug, Right Dose, Right Time - Using Genomic Data to Individualize Treatment
Official title: Right Drug, Right Dose, Right Time - Using Genomic Data to Individualize Treatment (The RIGHT Protocol)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: Pharmacogenomics
Personalized Medicine
Pharmacogenomic Varients
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 11098
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Study Participants - Total number of subjects identified with high risk for being prescribed a PGx drug
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Suzette Bielinski, PhD
role: PRINCIPAL_INVESTIGATOR
References: