Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System

November 28, 2023 updated by: Bruce Carleton, University of British Columbia

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Recruiting
        • Children's and Women's Health Centre of British Columbia
        • Contact:
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Recruiting
        • Children's Hospital of Eastern Ontario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any individual who is currently on an analgesic, antibiotic and/or mental health medication that is part of the panels.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: June 2020

We 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.
June 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Genome British Columbia
Genome Canada
Dynacare Laboratories, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2020

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

January 29, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H18-01383

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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