National Active Surveillance Network and Pharmacogenomics of Adverse Drug Reactions in Children

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of British Columbia

About this trial

The purpose of the study is (1) to identify and collect samples from children and adults who take drugs and have adverse drug reactions AND children and adults who take drugs and do not experience any adverse drug effects; (2) to determine if genetic differences between the two groups contribute to causing the adverse drug reactions; and (3) to develop patient specific drug dosing guidelines to prevent future adverse drug reactions. We also wish to compare the use of prescription drugs, medical and hospital services and vital statistics between BC participants who experience adverse drug reactions and those who do not.

Study hypothesis: Genetic differences may contribute to patients' response to drugs and may be responsible for adverse drug reactions.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children under 19 years who have taken drugs.

Biological parents of children who have had an ADR.

Patients/parents who speak and understand English (except in Quebec).

Adults (for validation of findings in children)

Disqualifiers

None

Trial population

Children under 19 years who have taken drugs and adults to replicate findings in children

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Determine the role of genetic and clinical factors in adverse drug reactions to develop risk mitigation strategies.

Time frame
December 2018

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

Genome Canada

Collaborator

Genome British Columbia

Collaborator

Child and Family Research Institute

Collaborator

Western University, Canada

Collaborator

Provincial Health Services Authority British Columbia

Collaborator

Health Canada

Collaborator

Canada Gene Cure

Collaborator

Eli Lilly and Company

Collaborator

Pfizer

Collaborator

Merck Sharp & Dohme LLC

Collaborator

Canadian Society of Clinical Pharmacology

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

Canada Foundation for Innovation

Collaborator

British Columbia Clinical Genomics Network

Collaborator