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Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System

Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04249375
Enrollment
150
Registered
2020-01-30
Start date
2020-02-20
Completion date
2028-03-01
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Drug Reaction (ADR)

Keywords

Pharmacogenomics, Pediatrics, Adverse Drug Reactions

Brief summary

This project addresses the problem of adverse drug reactions in the three most frequently prescribed therapeutic classes of drugs in children: antibiotics, analgesics, and mental health medications. We will conduct pilot testing of a pharmacogenomic testing panel and study how the tests and generated test results are utilized and understood by physicians, pharmacists, patients and their families.

Detailed description

The specific objectives are to: 1. Implement a pilot pharmacogenomics program to test medication safety and effectiveness of antibiotics, analgesics and mental health medication to enhance prescribing decision-making. 2. Develop data collection forms to collect necessary patient information from the prescribing physicians. 3. Develop pharmacogenomics reports to return results to physicians, pharmacists, patients and their families. 4. Determine how the tests and results are perceived and utilized by physicians, pharmacists, patients and their families.

Interventions

None listed

Sponsors

University of British Columbia
Lead SponsorOTHER
Genome British Columbia
CollaboratorINDUSTRY
Genome Canada
CollaboratorOTHER
Dynacare Laboratories, Inc.
CollaboratorUNKNOWN

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Participants will be enrolled if they can benefit from pharmacogenomic testing. This means their physician is considering the use of a drug that is part of the panels (analgesics, antibiotics, and mental health medication) or they are already using one.

Exclusion criteria

* Patients who do not speak or understand English.

Design outcomes

Primary

MeasureTime frameDescription
150 participants on analgesics, anti-infectives and psychotropics will be given pharmacogenomic recommendations for the risk of gene related adverse events prior to or during treatment.June 2020We will be able to determine the barriers and facilitators of the implementation of the pharmacogenomic service in a health care facility. This will be done by using standardized questionnaires after each pharmacogenomic report is issued. The prescriber and the patient will both answer questions about the utility of the genetic results, the format of the report and the clarity of the content. Results will be recorded and summarized every 25 patients in order to improve the service and the recommendations through the study.

Countries

Canada

Contacts

CONTACTBruce Carleton, PharmD.
bcarleton@popi.ubc.ca604-875-2179

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026