A Phase 2 interventional study of PGx panel test in Pharmacogenomic Drug Interaction, Side Effect of Drug and Ineffective Drug Action, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-14.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Prevention
The purpose of this study is to determine whether the implementation of pre-emptive pharmacogenomic (PGx) testing of a panel of clinically relevant PGx markers, to guide the dose and drug selection for 39 commonly prescribed drugs, will result in an overall reduction in the number of clinically relevant drug-genotype associated ADRs which are causally related to the initial drug of inclusion (referred to as 'index drug').
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
Exclusion Criteria:
Diagnostic Test: PGx panel test
Diagnostic Test: PGx panel test
In this prospective, non-randomized, step-wedge design controlled clinical study (PREPARE-MAYO Rochester, Mayo Clinic Health System), pre-emptive genotyping of a panel of clinically relevant PGx-markers, for which CPIC guidelines are available.
Adverse Drug Reaction (ADR)
The count of participants who experience any of the following ADR's: muscle aches, falling, tripping, fainting, palpations, emotional changes, or physical changes
Time frame: 48 weeks
PREPARE-MAYO Clinicians' and pharmacists' Questionnaire.
The 29-item PREPARE-MAYO Clinicians' and pharmacists' Questionnaire measures the Experience and Attitude, Knowledge, Knowledge testing and Needs assessment of clinicians and pharmacists. Each item is scored from 1 (disagree) to 4 (agree). Total possible scores range from 29 to 116, with lower scores indicating less knowledge and higher scores indicating more knowledge.
Time frame: 48 weeks
Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health Questionnaire
The 10-item PROMIS Global Health measures general, physical, mental and social health. Each item is scored from 1 (poor health) to 5 (excellent health). Total possible scores range from 10 to 50, with lower scores indicating worse state of health and higher scores indicating greater state of health.
Time frame: 48 weeks
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginniing 9 to 36 months following publication provided the investigator who proposes the use of the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data sharing use /sharing agreement with Mayo Clinic and the PI.
Supporting information: Study protocol, Sap, Icf
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