The PHOENIX Trial
Trial Synopsis
The Pre-Emptive Pharmacogenomics (PHOENIX) study is a two-group parallel randomised study designed to test the effectiveness of the PGx intervention to reduce adverse drug reactions (side effects) and treatment failures in hospitalised participants, and to obtain initial evidence regarding cost-effectiveness (can it save money).
Primary Outcome
The primary outcome is the occurrence of at least one clinically relevant side effect that is related to the medication with a known link to a pharmacogene. Here, we will compare the clinically relevant side effect from the patients in the intervention arm and the standard care arm.
What is a pharmacogenomics test?
For our trial, we will collect a sample of your genetic information (DNA) by swabbing the inside of your cheek. This sample will allow us to examine specific parts of your DNA to understand how you might respond to certain medications.
The pharmacogenomic test produces a report on the parts of your DNA that can affect how we respond to drugs and the associated published guidelines on what that means for the doctor thinking about prescribing these drugs.
This allows the clinical team to make an informed decision about your medication management.
No Change
Stop Drug
Change Dose
Different Drug
Trial Stages
1. Intervention
Following participant recruitment and consent, participants are assigned at random to either the intervention arm or the standard care arm.
Intervention arm: Participants will have a pharmacogenomics test straight away and the doctor can consider the results when they are prescribing the medication.
Standard of care arm: Patients will receive their normal care of 6 months before a pharmacogenomics test will be carried out.
2. The pharmacogenomics test
A swab is taken that loosens cells from the inside of a participant's cheek. From these cells, we can extract the genetic information, or DNA.
The pharmacogenomic testing will use the DNA to check a comprehensive panel of pharmacogenomic variants, which have been published in Clinical Pharmacogenetics Implementation Consortium (CPIC) and the Dutch Pharmacogenetics Working Group (DPWG) guidelines, for that participant.
3. The pharmacogenomic report
A report is derived from the test and will link to relevant, current, published CPIC and DPWG guidelines to the information about the pharmacogenomic variant found in the DNA.
4. Analysis
Incidence of clinically relevant side effects within 6 months of randomisation will be compared between intervention and control participants.