Personalized Medication Management for Multiple Medications Safety

Overseen By Cancer Trial Intake, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Liver transplant, Kidney transplant, others

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

Compensation: Varies

Number of Visits: Unknown

1300 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether a consultation with a Personalized Therapeutics Clinic, or PTC, will help participants lower the risk for side effects (drug-drug interactions and drug-gene interactions) when taking many medications and help providers improve prescribing decisions for participants. A PTC is a clinical that will test your genes to gather information about your health that may help guide prescribing advice and offer you new information about your prescriptions. Doctors leading this study will look for variations (differences) in your genes that may suggest that you are at greater risk of having side effects or a greater chance of benefiting from certain medications. Individuals in this study will participate for roughly 9 months.

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 the study focuses on managing and adjusting your medications based on genetic testing rather than stopping them.

What data supports the effectiveness of the Personalized Therapeutics Clinic (PTC) treatment for medication management?

Research shows that using a Genomic Prescribing System (GPS) in a clinical setting helps doctors make better medication decisions by providing genetic information about patients. This approach has been successfully implemented, with high physician adoption and routine use of the results, suggesting it can improve medication safety and effectiveness. ^{1 2 3 4 5}

Is personalized medication management generally safe for humans?

Personalized medication management, which uses genetic information to guide drug prescriptions, aims to improve safety by reducing adverse drug reactions (harmful effects from medications). Research suggests that using genetic data can help prevent these reactions, making it a promising approach for safer medication use. ^{2 6 7 8 9}

How is the Personalized Therapeutics Clinic (PTC) treatment different from other treatments for managing multiple medications?

The Personalized Therapeutics Clinic (PTC) treatment is unique because it uses pharmacogenomics (the study of how genes affect a person's response to drugs) to tailor medication plans based on an individual's genetic makeup. This approach aims to improve drug effectiveness and reduce side effects, especially in patients taking multiple medications. ^{10 11 12 13 14}

Research Team

Mark Ratain, MD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for adults over 18 at the University of Chicago Medical Center who take 5 or more medications, including those with specific drug interactions or genetic factors affecting medication response. It's not for those with liver/kidney transplants, in other gene studies, or unable to consent.

Inclusion Criteria

Adult participants cared for by a participating provider at University of Chicago Medical Center

I am taking 5 or more medications, including one that requires genetic testing.

I am 18 years old or older.

Exclusion Criteria

I am being considered for or have had a liver or kidney transplant.

Participation in another pharmacogenomic study

Participants who have previously received genotyping from another source

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive consultations at the Personalized Therapeutics Clinic (PTC) to assess drug-drug and drug-gene interactions and receive recommendations based on their profiles

9 months

Regular educational visits with clinic staff

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including emergency department visits, hospitalizations, and adverse events

9 months

Treatment Details

Interventions

• Personalized Therapeutics Clinic (PTC)

Trial Overview The study tests if a Personalized Therapeutics Clinic (PTC) can reduce side effects by analyzing participants' genes and current medications. The PTC aims to improve prescribing decisions based on drug-drug and drug-gene interactions over a period of roughly 9 months.

Participant Groups

Group I: Group 3: Prescribing Not Based on ANY Profile Information (Drug-Drug or Drug-Gene Interactions) Experimental Treatment 1 Intervention

Group three consists of subjects who will not participate in the Personalized Therapeutics Clinic or receive recommendations. These subjects will not have any recommendations from regarding their drug-drug interaction or drug-gene profiles. Both drug-drug interaction and drug-gene profiles will be kept hidden from all of their treating providers-regardless of whether the providers directing their care have agreed to participate in this research. Subjects in this group will not learn about their drug-drug interaction or drug-gene profiles during educational visits with clinic staff. Participants will randomly (like by a flip of the coin) assigned to a group.

Group II: Group 2: Prescribing Based ONLY on Information From Drug-Drug Interaction Profiles Experimental Treatment 1 Intervention

Group two consists of subjects who will participate in the Personalized Therapeutics Clinic where study doctors will make recommendations based on information only found in the subject's drug-drug interaction profile. Subjects in this group will also learn about their drug-drug interaction and drug-gene profiles during educational visits with clinic staff. Participants will randomly (like by a flip of the coin) assigned to a group.

Group III: Group 1: Prescribing Based on Information From Both Drug-Drug and Drug-Gene Profiles Experimental Treatment 2 Interventions

Group one consists of subjects who will participate in the Personalized Therapeutics Clinic where in which study doctors will make recommendations based on information found in both the subject's drug-drug interaction and drug-gene profiles. These recommendations will be given to participating providers. These recommendations will be communicated to healthcare providers who are directing the subject's care. These providers may work in hospitals, primary care, oncology, geriatrics, and mental and behavioral health. Each provider will have separately agreed to participate in this study. Subjects in this group will also learn about their drug-drug interaction and drug-gene profiles during educational visits with clinic staff. Participants will randomly (like by a flip of the coin) assigned to a group.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

The 1,200 Patients Project successfully implemented preemptive pharmacogenomic testing for 812 patients, achieving a 90% participation rate, which indicates strong patient interest in personalized medicine.

Results from the genomic prescribing system showed that physicians accessed pharmacogenomic information in 86% of visits, with 57% of medications receiving a 'green light' (favorable), demonstrating high physician adoption and relevance of the testing results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoption of a clinical pharmacogenomics implementation program during outpatient care--initial results of the University of Chicago "1,200 Patients Project". O'Donnell, PH., Danahey, K., Jacobs, M., et al.[2022]

Pharmacogenomics plays a crucial role in personalized medicine by helping to tailor drug treatments to individual patients based on their genetic makeup, which can enhance therapeutic efficacy and reduce the risk of drug toxicity.

Despite the advancements in pharmacogenomics, its integration into clinical practice has been slow, but recent findings suggest that there are promising opportunities for immediate application, particularly in improving drug safety and targeted cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacogenomics steps toward personalized medicine. Xie, HG., Frueh, FW.[2019]

The first pharmacogenomics test approved by the FDA assesses the CYP2D6 and CYP2C19 genotypes, which can help tailor medication choices and dosages for patients, potentially improving treatment outcomes.

An interdisciplinary approach in pharmacogenomics and personalized medicine is essential for effectively integrating genomic information into clinical practice, moving towards more precise drug prescriptions based on individual genetic profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving pharmacotherapy outcomes by pharmacogenomics: from expectation to reality? Vizirianakis, IS.[2013]

Pharmacogenetics aims to optimize drug therapy by tailoring treatments to individual patients, improving both efficacy and safety, especially in oncology.

Therapeutic drug monitoring (TDM) combined with pharmacogenetic testing can help predict how a patient metabolizes drugs, allowing for personalized dosing to reduce the risk of treatment failure or toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical application, limits and perspectives of pharmacogenetic and pharmacokinetic analysis of anticancer drugs]. Chantry, AS., Quaranta, S., Ciccolini, J., et al.[2022]

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]

Adverse drug reactions lead to over 2 million hospitalizations and 100,000 deaths annually in the U.S., highlighting the urgent need for personalized medicine approaches like pharmacogenetics and pharmacogenomics to improve drug safety and efficacy.

Understanding genetic differences in drug metabolism can help tailor treatments to individuals, potentially reducing adverse reactions and improving public health, although challenges such as privacy concerns and the need for education in the clinical community remain significant barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacogenetics and the concept of individualized medicine. Shastry, BS.[2021]

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]

In a study of 52,942 patients over five years, 64.8% were prescribed at least one medication that could be influenced by genetic variants, highlighting the commonality of pharmacogenetic prescribing opportunities.

Implementing a preemptive genotyping program could potentially prevent 383 adverse events linked to specific medications, suggesting that this approach may enhance patient safety compared to traditional reactive methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing drug outcomes through pharmacogenetics: a case for preemptive genotyping. Schildcrout, JS., Denny, JC., Bowton, E., et al.[2022]

Pharmacogenomics can help predict adverse drug reactions (ADRs) by identifying genetic variations that affect how individuals respond to medications, addressing a significant issue in drug safety.

The review highlights successful examples of pharmacogenomics influencing clinical practice and discusses future areas where it could improve drug safety, while also acknowledging the challenges in implementing these tests in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The emerging era of pharmacogenomics: current successes, future potential, and challenges. Lee, JW., Aminkeng, F., Bhavsar, AP., et al.[2021]

Precision medicine, which uses genetic information to guide drug therapy, can enhance drug efficacy and reduce adverse events, especially in patients taking multiple medications (polypharmacy).

The authors implemented a five-step precision medicine protocol over ten years, demonstrating its effectiveness in tailoring treatments based on individual patient characteristics and pharmacogenetic test results, particularly for those with complex medical histories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten Years of Experience Support Pharmacogenetic Testing to Guide Individualized Drug Therapy. Peña-Martín, MC., García-Berrocal, B., Sánchez-Martín, A., et al.[2022]

Pharmacogenomics (PGx) is changing how medications are prescribed by allowing doctors to tailor drug prescriptions based on individual genetic factors, which can enhance treatment effectiveness and reduce side effects.

In Switzerland, doctors can use validated PGx tests for five specific drugs, indicating a move towards personalized medicine, but this requires proper sharing of PGx data and support for clinicians in making informed prescribing decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacogenomics : a toolbox to improve drug prescription]. Jaccard, E., Redin, C., Girardin, F., et al.[2020]

Over 90% of individuals have pharmacogenomic (PGx) variants that can inform medication choices, leading to improved treatment efficacy and reduced adverse drug reactions (ADRs).

The University of Minnesota successfully implemented a PGx testing program that includes a multiplex PCR assay for 20 genes, enhancing the ability of clinicians to use genetic information for personalized medicine through a user-friendly software tool for translating genetic data into actionable treatment recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Implementation of In-House Pharmacogenomic Testing Program at a Major Academic Health System. Mroz, P., Michel, S., Allen, JD., et al.[2021]

Pharmacogenomics helps understand how different patients respond to drugs based on their genetic profiles, which can lead to more effective and safer treatments tailored to individual needs.

The review highlights the importance of two types of biomarkers—prognostic and predictive—that can classify patients into subgroups, allowing for personalized treatment recommendations based on their specific responses to therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacogenomic biomarkers for personalized medicine. Chen, JJ., Lin, WJ., Chen, HC.[2015]

The study developed a protocol to use preemptive pharmacogenomics (PGx) data integrated into electronic medical records (EMR) to guide personalized statin therapy, targeting patients most likely to benefit from this approach.

Out of 2000 participants invited from the Mayo Clinic Biobank, 1013 provided blood samples for PGx testing, which included genotyping and sequencing of relevant genes, indicating a significant interest in personalized medicine and the potential for improved treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preemptive genotyping for personalized medicine: design of the right drug, right dose, right time-using genomic data to individualize treatment protocol. Bielinski, SJ., Olson, JE., Pathak, J., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adoption of a clinical pharmacogenomics implementation program during outpatient care--initial results of the University of Chicago "1,200 Patients Project". [2022]

2. England pubmed.ncbi.nlm.nih.gov

Pharmacogenomics steps toward personalized medicine. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Improving pharmacotherapy outcomes by pharmacogenomics: from expectation to reality? [2013]

4. France pubmed.ncbi.nlm.nih.gov

[Clinical application, limits and perspectives of pharmacogenetic and pharmacokinetic analysis of anticancer drugs]. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Relevance of a 16-Gene Pharmacogenetic Panel Test for Medication Management in a Cohort of 135 Patients. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Pharmacogenetics and the concept of individualized medicine. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Advances in pharmacogenetics and pharmacogenomics. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Optimizing drug outcomes through pharmacogenetics: a case for preemptive genotyping. [2022]

9. Denmark pubmed.ncbi.nlm.nih.gov

The emerging era of pharmacogenomics: current successes, future potential, and challenges. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Ten Years of Experience Support Pharmacogenetic Testing to Guide Individualized Drug Therapy. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

[Pharmacogenomics : a toolbox to improve drug prescription]. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Development and Implementation of In-House Pharmacogenomic Testing Program at a Major Academic Health System. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Pharmacogenomic biomarkers for personalized medicine. [2015]

14. England pubmed.ncbi.nlm.nih.gov

Preemptive genotyping for personalized medicine: design of the right drug, right dose, right time-using genomic data to individualize treatment protocol. [2021]