Pharmacogenetic Testing for Optimizing Drug Therapy

(ToPP-UP Trial)

Overseen By Joshua N Terrell, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Previous pharmacogenetic testing, Transplant, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how genetic testing can personalize medication plans for better health outcomes. Participants will receive genetic testing results either immediately or after 12 months. It suits adults with at least three prescriptions who have recently changed their medication. Conditions such as anxiety, heart problems, or chronic pain might benefit from personalized drug plans. This trial offers a chance to see how genetics can improve everyday treatment for various health issues through panel-based pharmacogenetic genotyping. As an unphased trial, it provides a unique opportunity to contribute to groundbreaking research that could enhance personalized medicine for future patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It seems likely that you can continue your medications since the study involves optimizing drug therapy based on genetic testing.

What prior data suggests that panel-based pharmacogenetic genotyping is safe?

Research shows that genetic testing can help select the best medications, making treatments safer. Studies have found that using genetic information can prevent adverse drug reactions and enhance treatment effectiveness. This testing identifies genetic differences that may influence responses to certain medications.

The process is safe because it uses genetic information to inform drug choices without altering genes or the body, making it generally well-tolerated. However, like any medical test, there are some risks, such as concerns about the privacy of genetic data. Overall, the goal is to improve medication effectiveness based on an individual's unique genetic makeup. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how pharmacogenetic testing can personalize and optimize drug therapy. Unlike traditional methods that often use a one-size-fits-all approach, this testing analyzes genetic markers to predict how individuals will respond to specific medications. This can potentially reduce adverse drug reactions and improve treatment efficacy. The trial compares immediate access to genetic results with a delayed approach, aiming to demonstrate the impact of timely genetic information on healthcare decisions.

What evidence suggests that panel-based pharmacogenetic genotyping is effective for optimizing drug therapy?

Research shows that genetic information can help customize drug treatments for individuals. This trial will compare two approaches: immediate panel-based pharmacogenetic genotyping and delayed panel-based pharmacogenetic genotyping. Studies have found that this method can reduce negative reactions to medications and improve their effectiveness. For example, a study with older adults showed that knowing their genetic details helped predict their response to certain drugs. Another review found that 92.5% of people had genetic differences affecting their reaction to some medications. Overall, this method aims to make drug therapy safer and more effective by considering each person's unique genetic makeup. ^{3 6 7 8 9}

Who Is on the Research Team?

Julio Duarte, PharmD, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for adults over 18 who take at least three prescription drugs and have had a medication change in the last 8 months due to various conditions like depression, heart issues, or chronic pain. It's not for those with past pharmacogenetic testing, organ transplants, kidney dialysis, or less than a year to live.

Inclusion Criteria

I've had a medication change or new diagnosis treatable with medication in the last 8 months.

I am older than 18 years.

I am currently taking three or more prescribed medications.

Exclusion Criteria

I am on chronic kidney dialysis.

I have had a stem cell or liver transplant from a donor.

I have had genetic testing for medication response.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Immediate panel-based pharmacogenetic genotyping

Subjects assigned to the immediate pharmacogenetic genotyping group will be tested and have their results both entered into their electronic health record as well as provided to them

2-4 weeks

1 visit (in-person)

Delayed panel-based pharmacogenetic genotyping

Subjects assigned to delayed panel-based pharmacogenetic genotyping will be tested, but their results will not be released until after their participation in the study has ended

12 months

1 visit (in-person)

Follow-up

Participants are monitored for changes in patient treatment satisfaction between baseline and 12 months after enrollment

12-14 months

What Are the Treatments Tested in This Trial?

Interventions

• Panel-based pharmacogenetic genotyping

Trial Overview

The study tests preemptive pharmacogenetic genotyping—a way to personalize drug therapy based on genetics—to see if it improves patient outcomes. It focuses on underserved groups including racial minorities to ensure broad benefits.

How Is the Trial Designed?

Group I: Immediate panel-based pharmacogenetic genotyping Experimental Treatment 1 Intervention

Subjects assigned to the immediate pharmacogenetic genotyping group will be tested and have their results both entered into their electronic health record as well as provided to them within 2-4 weeks from enrollment.

Group II: Delayed panel-based pharmacogenetic genotyping Experimental Treatment 1 Intervention

Subjects assigned to delayed panel-based pharmacogenetic genotyping will be tested, but their results will not be released until after their participation in the study has ended (12 months after enrollment).

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Human Genome Research Institute (NHGRI)

Collaborator

Trials

273

Recruited

299,000+

Published Research Related to This Trial

Pharmacogenomics helps explain why different people respond very differently to medications due to genetic variations in drug-metabolizing enzymes, transporters, and receptors.

By understanding these genetic differences, we can improve drug discovery and personalize treatments, potentially reducing the high rates of adverse drug reactions that contribute to significant health risks in the USA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in pharmacogenetics and pharmacogenomics. Vesell, ES.[2019]

Serious adverse drug reactions are a leading cause of death in the USA and contribute significantly to healthcare costs, highlighting the need for better risk management in drug prescriptions.

Pharmacogenomic testing, which identifies genetic factors that affect drug response, is becoming increasingly important, with regulatory agencies pushing for mandatory testing for certain medications to prevent adverse reactions and improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacogenomics of adverse drug reactions: practical applications and perspectives. Becquemont, L.[2013]

In a study involving 135 patients, pharmacogenetic (PGx) testing using a 16-gene panel identified at least one actionable variant in every participant, demonstrating its comprehensive utility in guiding medication choices.

PGx-guided recommendations led to changes in treatment for 32.4% of patients based on specific drug-gene interactions, highlighting the potential for personalized medicine to improve therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Relevance of a 16-Gene Pharmacogenetic Panel Test for Medication Management in a Cohort of 135 Patients. Niedrig, DF., Rahmany, A., Heib, K., et al.[2021]

A staggering 99% of veterans using VHA pharmacy services are projected to carry at least one actionable pharmacogenetic variant, indicating a high potential for personalized medicine to improve drug prescribing.

Over half of the veterans (54.8%) received at least one level A drug that could be influenced by these genetic variants, suggesting that pharmacogenetic testing could significantly impact treatment decisions for commonly prescribed medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Projected Prevalence of Actionable Pharmacogenetic Variants and Level A Drugs Prescribed Among US Veterans Health Administration Pharmacy Users. Chanfreau-Coffinier, C., Hull, LE., Lynch, JA., et al.[2020]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10373039/

Analysis of a panel-based pharmacogenomics testing ...

The goal of PGx is to use a patient's genetic information to guide medication therapy to help reduce adverse drug events and optimize drug efficacy (through ...

2.

mdpi.com

mdpi.com/1999-4923/16/8/1079

A Pharmacogenetic Panel-Based Prediction of the Clinical ...

The carrier status of the actionable drug–gene pair is predictive for the clinical outcomes in elderly patients with CAD and polypharmacy.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1535947624000276

Personalized Drug Therapy: Innovative Concept Guided ...

Pharmacogenomics studies how genes impact an individual's response to specific drugs and can predict adverse reactions and an increased risk of subtherapeutic ...

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annualreviews.org

annualreviews.org/content/journals/10.1146/annurev-pharmtox-061724-080935?crawler=true&mimetype=application/pdf

Pharmacogenetic Panel Testing: A Review of Current ...

Abstract. Pharmacogenetics (PGx) aims to optimize drug treatment outcomes by us- ing a patient's genetic profile for individualized drug and ...

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Implementation of pre‐emptive testing of a pharmacogenomic ...

Consistent with data from the literature, the genotyping results showed that 92.5% of the patients were carriers of at least one actionable ...

6.

nature.com

nature.com/articles/s41431-025-01950-6

Pharmacogenomics in drug therapy: global regulatory ...

PGx testing, particularly for high-risk alleles associated with medications, is critical for optimizing medication safety and efficacy. Evidence ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3785311/

Optimizing drug outcomes through pharmacogenetics

Routine integration of genotype data into drug decision-making could improve patient safety, particularly if many relevant genetic variants can be assayed ...

8.

ajmc.com

ajmc.com/view/pharmacogenomics-for-improved-outcomes-and-decreased-costs-in-health-care

Pharmacogenomics for Improved Outcomes and ...

Pharmacogenomics (PGx) involves the study of patients' unique genes to predict their individual response to drugs.

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bps.ac.uk

bps.ac.uk/getmedia/b43a3dca-1bbf-4bff-9379-20bef9349a8c/Personalised-prescribing-full-report.pdf.aspx

Using pharmacogenomics to improve patient outcomes

The centralised genomic laboratories are well placed to offer and coordinate panel-based pharmacogenomic testing as their consolidated resources and expertise.