Personalized Medication Management for Multiple Medications Safety
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Chicago
Disqualifiers: Liver transplant, Kidney transplant, others
No Placebo Group
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.
12345Is 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.
26789How 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.
1011121314Eligibility 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
+1 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Group I: Group 3: Prescribing Not Based on ANY Profile Information (Drug-Drug or Drug-Gene Interactions)Experimental Treatment1 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 ProfilesExperimental Treatment1 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 ProfilesExperimental Treatment2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Chicago MedicineChicago, IL
Loading ...
Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
References
Adoption of a clinical pharmacogenomics implementation program during outpatient care--initial results of the University of Chicago "1,200 Patients Project". [2022]Pharmacogenomic testing is viewed as an integral part of precision medicine. To achieve this, we originated The 1,200 Patients Project which offers broad, preemptive pharmacogenomic testing to patients at our institution. We analyzed enrollment, genotype, and encounter-level data from the first year of implementation to assess utility of providing pharmacogenomic results. Results were delivered via a genomic prescribing system (GPS) in the form of traffic lights: green (favorable), yellow (caution), and red (high risk). Additional supporting information was provided as a virtual pharmacogenomic consult, including citation to relevant publications. Currently, 812 patients have participated, representing 90% of those approached; 608 have been successfully genotyped across a custom array. A total of 268 clinic encounters have occurred at which results were accessible via the GPS. At 86% of visits, physicians accessed the GPS, receiving 367 result signals for medications patients were taking: 57% green lights, 41% yellow lights, and 1.4% red lights. Physician click frequencies to obtain clinical details about alerts varied according to color severity (100% of red were clicked, 72% yellow, 20% green). For 85% of visits, clinical pharmacogenomic information was available for at least one drug the patient was taking, suggesting relevance of the delivered information. We successfully implemented an individualized health care model of preemptive pharmacogenomic testing, delivering results along with pharmacogenomic decision support. Patient interest was robust, physician adoption of information was high, and results were routinely utilized. Ongoing examination of a larger number of clinic encounters and inclusion of more physicians and patients is warranted.
Pharmacogenomics steps toward personalized medicine. [2019]The goal of personalized medicine is to maximize the likelihood of therapeutic efficacy and to minimize the risk of drug toxicity for an individual patient. One of the major contributors to this concept is pharmacogenomics. Marked interindividual genetic variation contributes significantly to both susceptibility to diseases, and response to drugs. Even though pharmacogenomics is not a new science, the translation of pharmacogenomics into clinical practice (i.e., personalized medicine) has not taken place at the same pace as science is delivering new results. It is felt that a large number of recent pharmacogenomic findings allow bold steps to be taken toward personalized medicine. This review collates a variety of examples that have great potential for immediate and effective introduction into clinical practice. In addition, other exploratory examples with a particular focus on drug safety and targeted cancer therapy are summarized.
Improving pharmacotherapy outcomes by pharmacogenomics: from expectation to reality? [2013]The genomic era is now a reality and the extraction of genomic information with a practical value in healthcare represents the next challenge following the completion of the Human Genome Project. To this end, the first pharmacogenomics test approved by the US Food & Drug Administration for assessing cytochrome P450 (CYP)2D6 and CYP2C19 genotype in the implementation of pharmacotherapy decisions in patients, is expected to improve pharmaceutical care outcomes, at least for drugs that are substrates or inhibitors of these enzymes. Furthermore, the progress already achieved and the experience gained in the fields of pharmacogenomics and personalized medicine has clearly demonstrated that an interdisciplinary approach could better serve the target of improving pharmacotherapy outcomes in routine clinical practice. Such an approach will obviously move drug prescription towards pharmacotyping, a stage where the drug selection and dosage process carried out by medical practitioners for any given patient will be advanced by genomic knowledge and information.
[Clinical application, limits and perspectives of pharmacogenetic and pharmacokinetic analysis of anticancer drugs]. [2022]Despite significant progress in the discovery and design of drugs, the interindividual variability to the standard dose of a given drug remains a serious problem in clinical practice. In the future, the aim of pharmacogenetic is to provide new strategies for optimizing drug therapy, both in terms of efficacy and safety. The clinical validation of an increasing number of pharmacogenetic tests, as well as the development of new highly efficient technologies should further promote pharmacogenetics in clinical practice and lead to the optimization and individualization, before treatment, of drug therapy. Therapeutic drug monitoring is a valid tool to determine the pharmacokinetic of a drug and individualized drug therapy, adjusting patient's dose requirement through the measurement and interpretation of drug concentrations. Thus, phenotyping and genotyping tests are now available that determine or predict the metabolic status of an individual and enable the evaluation of risk of drug failure or toxicity. Based on clinical applications, this review focuses on interest of pharmacogenetics, in combination with anticancer agents TDM, on the individualization of treatments used in oncology.
Clinical Relevance of a 16-Gene Pharmacogenetic Panel Test for Medication Management in a Cohort of 135 Patients. [2021]There is a growing number of evidence-based indications for pharmacogenetic (PGx) testing. We aimed to evaluate clinical relevance of a 16-gene panel test for PGx-guided pharmacotherapy. In an observational cohort study, we included subjects tested with a PGx panel for variants of ABCB1, COMT, CYP1A2, CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP2C19, CYP2D6, CYP4F2, DPYD, OPRM1, POR, SLCO1B1, TPMT and VKORC1. PGx-guided pharmacotherapy management was supported by the PGx expert system SONOGEN XP. The primary study outcome was PGx-based changes and recommendations regarding current and potential future medication. PGx-testing was triggered by specific drug-gene pairs in 102 subjects, and by screening in 33. Based on PharmGKB expert guidelines we identified at least one "actionable" variant in all 135 (100%) tested patients. Drugs that triggered PGx-testing were clopidogrel in 60, tamoxifen in 15, polypsychopharmacotherapy in 9, opioids in 7, and other in 11 patients. Among those, PGx variants resulted in clinical recommendations to change PGx-triggering drugs in 33 (32.4%), and other current pharmacotherapy in 23 (22.5%). Additional costs of panel vs. single gene tests are moderate, and the efficiency of PGx panel testing challenges traditional cost-benefit calculations for single drug-gene pairs. However, PGx-guided pharmacotherapy requires specialized expert consultations with interdisciplinary collaborations.
Pharmacogenetics and the concept of individualized medicine. [2021]Adverse drug reaction in patients causes more than 2 million hospitalizations including 100,000 deaths per year in the United States. This adverse drug reaction could be due to multiple factors such as disease determinants, environmental and genetic factors. In order to improve the efficacy and safety and to understand the disposition and clinical consequences of drugs, two rapidly developing fields--pharmacogenetics (focus is on single genes) and pharmacogenomics (focus is on many genes)--have undertaken studies on the genetic personalization of drug response. This is because many drug responses appear to be genetically determined and the relationship between genotype and drug response may have a very valuable diagnostic value. Identification and characterization of a large number of genetic polymorphisms (biomarkers) in drug metabolizing enzymes and drug transporters in an ethnically diverse group of individuals may provide substantial knowledge about the mechanisms of inter-individual differences in drug response. However, progress in understanding complex diseases, its negative psychosocial consequences, violation of privacy or discrimination, associated cost and availability and its complexity (extensive geographic variations in genes) may become potential barriers in incorporating this pharmacogenetic data in risk assessment and treatment decisions. In addition, it requires increased enthusiasm and education in the clinical community and an understanding of pharmacogenetics itself by the lay public. Although individualized medications remain as a challenge for the future, the pharmacogenetic approach in drug development should be still continued. If it becomes a reality, it delivers benefits to improve public health and allow genetically subgroup diseases thereby avoiding adverse drug reactions (by knowing in advance who should be treated with what drug and how).
Advances in pharmacogenetics and pharmacogenomics. [2019]Large differences among normal human subjects in the efficacy and safety of many therapeutic agents are caused by genetically controlled polymorphisms of drug-metabolizing enzymes, drug transporters, and drug receptors. Development of pharmacogenomics as a new field has accelerated progress in pharmacogenetics by elucidating at the level of the human genome the inherited basis for those large interindividual variations. Examples discussed in this review illustrate how this approach can be used not only to guide new drug discovery but also to individualize therapy. Adverse drug reactions, often attributable to large differences among subjects in drug response, constitute a leading cause of death in the USA. Such high morbidity and mortality could be reduced by application of the principles of pharmacogenetics and pharmacogenomics, defined broadly as the study of genetically caused variability in drug response.
Optimizing drug outcomes through pharmacogenetics: a case for preemptive genotyping. [2022]Routine integration of genotype data into drug decision making could improve patient safety, particularly if many relevant genetic variants can be assayed simultaneously before prescribing the target drug. The frequency of opportunities for pharmacogenetic prescribing and the potential adverse events (AEs) mitigated are unknown. We examined the frequency with which 56 medications with known outcomes influenced by variant alleles were prescribed in a cohort of 52,942 medical home patients at Vanderbilt University Medical Center (VUMC). Within a 5-year window, we estimated that 64.8% (95% confidence interval (CI): 64.4-65.2%) of individuals were exposed to at least one medication with an established pharmacogenetic association. Using previously published results for six medications with severe, well-characterized, genetically linked AEs, we estimated that 383 events (95% CI, 212-552) could have been prevented with an effective preemptive genotyping program. Our results suggest that multiplexed, preemptive genotyping may represent an efficient alternative approach to current single-use ("reactive") methods and may also improve safety.
The emerging era of pharmacogenomics: current successes, future potential, and challenges. [2021]The vast range of genetic diversity contributes to a wonderful array of human traits and characteristics. Unfortunately, a consequence of this genetic diversity is large variability in drug response between people, meaning that no single medication is safe and effective in everyone. The debilitating and sometimes deadly consequences of adverse drug reactions (ADRs) are a major and unmet problem of modern medicine. Pharmacogenomics can uncover associations between genetic variation and drug safety and has the potential to predict ADRs in individual patients. Here we review pharmacogenomic successes leading to changes in clinical practice, as well as clinical areas probably to be impacted by pharmacogenomics in the near future. We also discuss some of the challenges, and potential solutions, that remain for the implementation of pharmacogenomic testing into clinical practice for the significant improvement of drug safety.
Ten Years of Experience Support Pharmacogenetic Testing to Guide Individualized Drug Therapy. [2022]Precision medicine utilizing the genetic information of genes involved in the metabolism and disposition of drugs can not only improve drug efficacy but also prevent or minimize adverse events. Polypharmacy is common among multimorbid patients and is associated with increased adverse events. One of the main objectives in health care is safe and efficacious drug therapy, which is directly correlated to the individual response to treatment. Precision medicine can increase drug safety in many scenarios, including polypharmacy. In this report, we share our experience utilizing precision medicine over the past ten years. Based on our experience using pharmacogenetic (PGx)-informed prescribing, we implemented a five-step precision medicine protocol (5SPM) that includes the assessment of the biological-clinical characteristics of the patient, current and past prescription history, and the patient's PGx test results. To illustrate our approach, we present cases highlighting the clinical relevance of precision medicine with a focus on patients with a complex history and polypharmacy.
[Pharmacogenomics : a toolbox to improve drug prescription]. [2020]As a result of advances in pharmacogenomics (PGx), the paradigm that a single dose of a drug is extrapolated to an entire population is set to change. Personalising drug prescriptions according to individual genomic determinants would make it possible to increase the effectiveness and tolerance of treatments. In Switzerland, any doctor can prescribe validated PGx tests for five actionable drugs : abacavir, carbamazepine, thiopurines [azathioprine], fluoropyrimidines [5-FU, capecitabine] and irinotecan. Such an approach presupposes that PGx data are shared with trained clinicians and that prescribing aids can guide them.
Development and Implementation of In-House Pharmacogenomic Testing Program at a Major Academic Health System. [2021]Pharmacogenomics (PGx) studies how a person's genes affect the response to medications and is quickly becoming a significant part of precision medicine. The clinical application of PGx principles has consistently been cited as a major opportunity for improving therapeutic outcomes. Several recent studies have demonstrated that most individuals (> 90%) harbor PGx variants that would be clinically actionable if prescribed a medication relevant to that gene. In multiple well-conducted studies, the results of PGx testing have been shown to guide therapy choice and dosing modifications which improve treatment efficacy and reduce the incidence of adverse drug reactions (ADRs). Although the value of PGx testing is evident, its successful implementation in a clinical setting presents a number of challenges to molecular diagnostic laboratories, healthcare systems, providers and patients. Different molecular methods can be applied to identify PGx variants and the design of the assay is therefore extremely important. Once the genotyping results are available the biggest technical challenge lies in turning this complex genetic information into phenotypes and actionable recommendations that a busy clinician can effectively utilize to provide better medical care, in a cost-effective, efficient and reliable manner. In this paper we describe a successful and highly collaborative implementation of the PGx testing program at the University of Minnesota and MHealth Fairview Molecular Diagnostic Laboratory and selected Pharmacies and Clinics. We offer detailed descriptions of the necessary components of the pharmacogenomic testing implementation, the development and technical validation of the in-house SNP based multiplex PCR based assay targeting 20 genes and 48 SNPs as well as a separate CYP2D6 copy number assay along with the process of PGx report design, results of the provider and pharmacists usability studies, and the development of the software tool for genotype-phenotype translation and gene-phenotype-drug CPIC-based recommendations. Finally, we outline the process of developing the clinical workflow that connects the providers with the PGx experts within the Molecular Diagnostic Laboratory and the Pharmacy.
Pharmacogenomic biomarkers for personalized medicine. [2015]Pharmacogenomics examines how the benefits and adverse effects of a drug vary among patients in a target population by analyzing genomic profiles of individual patients. Personalized medicine prescribes specific therapeutics that best suit an individual patient. Much current research focuses on developing genomic biomarkers to identify patients, to identify which patients would benefit from a treatment, have an adverse response, or no response at all, prior to treatment according to relevant differences in risk factors, disease types and/or responses to therapy. This review describes the use of the two personalized medicine biomarkers, prognostic and predictive, to classify patients into subgroups for treatment recommendation.
Preemptive genotyping for personalized medicine: design of the right drug, right dose, right time-using genomic data to individualize treatment protocol. [2021]To report the design and implementation of the Right Drug, Right Dose, Right Time-Using Genomic Data to Individualize Treatment protocol that was developed to test the concept that prescribers can deliver genome-guided therapy at the point of care by using preemptive pharmacogenomics (PGx) data and clinical decision support (CDS) integrated into the electronic medical record (EMR).