For Public

• What is Pharmacogenomics?
  Pharmacogenomics is the study of how our genes (genetic information) influence our responses to medications. The term "pharmacogenomics" combines "pharmacology" (the study of the uses and effects of medications) and "genomics" (the study of genes and their functions).
  We can test for genetic differences that might put an individual at risk of severe side-effects or mean that they are likely to receive no benefit from a specific medicine. The pharmacogenomic test can help doctors and patients avoid unsuitable medications, consider a different dose, or choose a better-tolerated medicine.
  It is estimated that almost everyone in the population (>95%) carries at least one gene variation that affects our response to certain medicines.
• What are Pharmacogenes?
  • Genes are short segments of DNA that carry the instructions for making proteins. Some of these proteins are needed for medicines to work.
  • Pharmacogenes are specific genes that determines on how we respond to medication
• What is a pharmacogenetic test?
  • A pharmacogenomic test is obtained from a cheek swab which is not painful.
  • A pharmacogenomic test informs the doctor to make medication changes if required.
  • Please bear in mind that a pharmacogenomic test should not be confused with other commercially available DNA tests. A pharmacogenomic test DOES NOT provide information about undiagnosed conditions, your risk of developing disease (e.g., breast cancer or Alzheimer's disease), inherited traits (e.g., eye colour), paternity/maternity, or forensic information. A pharmacogenomic test looks only at specific parts of a person's genes (the pharmacogenes) to assess how that person is likely to respond to specific medicines.
• Why are we doing the PHOENIX trial?
  The goal of our trial is to understand if checking a person’s genes at the start of their treatment can help doctors choose the most effective medicines. We believe that matching medicines to a person’s unique genetic information can reduce the risk of severe side-effects, make the medicines prescribed for each person more effective, and may improve quality of life.
  Understanding the impact of pharmacogenomic testing will help us assess the benefits for individual patients, and how pharmacogenomic testing could be done in NHS Scotland, including potential cost savings.
  No recent research studies that show that pharmacogenomic testing improve prescribing of medications which can save money for NHS.
  This is why we are doing the PHOENIX trial.

  
• What will happen to me if I take part?
  • Understand the study procedures: Your participation is voluntary. You will first be asked to read another version of this information sheet that contains more details about the study including how data is used.
  • Informed Consent: If you are happy with the information you have read about the study and wish to take part you will be asked to sign a consent form.
  • Provide Information: Information will be collected about you (age, sex, ethnicity) and your health (other medical conditions and the medicines you take, allergies or intolerances).
  • Cheek Swab: You will be asked to give a cheek swab sample.
  • Study Procedures: To check if using the test in a group of participants improves medicine safety or quality of life, we need to compare to a group of participants who have not yet had the test. You will be allocated to one of these groups at random, like the toss of a coin. Both groups will have the DNA test performed during the study, one early and the other after three months. You will not know which group you are in unless the doctor looking after you needs to change your medications.
  • Follow-up Blood Test: If the medication that you have been started on requires a blood test this will be done at 4 weeks.
  • Follow-up Questionnaires: You will be asked to fill out surveys about medicines side-effects and how often you take or miss doses each month for three months. You will be asked about your quality of life every month for three months.
  • 
• Explain just the trial design in simple terms.
  • Who can take part? If you are aged 18 years or older, are admitted to hospital and start on a new drug that has been known to be affected by your genetic information (DNA).
  • Laboratory (Pharmacogenomics) test: The PHOENIX trial, by taking a swab from the inside of your cheek, can look at your DNA for information that may tell us about how you might respond to certain drugs.
  • What does that mean? This test produces a report about the parts of your DNA that can affect how you are likely to respond to certain medicines.
    This means that your doctor may be able to make changes to your medicine which could reduce side-effects, make the medicine safer and more effective or chose a different medicine
• Explain the Two Groups in the Trial that are being compared.
  • Once you have given your sample you will be put into one of two groups at random, like the toss of a coin. The two possible groups are:
  • Intervention Arm: The result of the cheek swab will be provided to the clinical team looking after you within 10 days. The research team will inform the clinical team looking after you if a medication change is recommended. The clinical team looking after you will decide if a medication change should be made and will inform your GP.
  • Standard of Care Arm: DNA will be extracted from your cheek swab sample and stored. It will be tested at 3 months and the research team will inform the clinical team looking after you if a medication change is recommended. The clinical team will inform your GP, if a medication change should be made.
  • You will not be informed which group you are in. You will only know which group you have been allocated to if the result from the pharmacogenomic test indicates that a medication change should be considered which will be acted upon by your clinical team within 10 days (intervention arm) or at 3 months (standard care arm).
• What are the medicines assessed in this trial?
  • The PHOENIX trial tests genes that may have an impact on around 60 drugs. These drugs are used in a variety of conditions and belong to one of the following broad groups

  • Drug Category
    Drugs used to control irregular heartbeats
    Antibiotics
    Anti-sickness medicines
    Drugs to treat reflux or protect the stomach
    Drugs used to treat movement disorders
    Drugs for Gout
    Drugs for HIV
    Blood Thinners
    Drugs used for mental health conditions
    Drugs for cholesterol control
    Drugs used to suppress the immune system
    Anti-cancer drugs
    Drugs used to stop seizures
    Beta Blockers
    Painkillers
    Antifungals
    Drugs used to treat urinary incontinence

• What will happen to the samples that I have provided in the study?
  • The cheek swab collected as part of this trial will be sent off, labelled with the unique sample ID, to MyDNA’s lab facility called GENEbyGENE in Houston, Texas USA. Please be assured that your identifiable data will be removed before sending, and only necessary information will be given which will include the current medications that you are on, gender, and age. The sample ID will be linked to your unique trial ID to allow us to track your sample. The laboratory will extract the genetic information and run the test to look at the pharmacogenomic information.
  • The blood samples that you provide are routine blood samples used to monitor for any adverse effects of the medicine that you have recently started in routine care. We will measure test specific to your prescribed medicines. The result of the blood sample will be reviewed using your hospital number by the research team. If there are any follow up tests required, you and your GP will be informed.
  • If you have consented for your DNA sample to be shipped back to the UK, your sample will stored in a pseudonymised manner in the BHF Glasgow Cardiovascular Research Centre, University of Glasgow for 10 years. Only the research team will have access to your samples which may be used for future ethically approved studies. If you have not consented to this, your sample will be destroyed.
• What will happen to the data that I have provided in the study?
  • Only the research team will have access to your health care records within NHSGGC to allow the follow up on your healthcare information that is relevant to the trial, this includes: medical history, current medications, healthcare encounters and blood results.
  • Each participant who is enrolled into the trial will be given a unique trial ID. Only the appropriately qualified members of the research team will have access to identifiable information. All other members of the research team will only be able to see pseudonymised data.
  • Pseudonymised data means that your personal identifiers (such as your name or CHI) have been replaced with a unique set of letters and numbers (this is known as your unique trial ID), but you could be re-identified by a key (that links the unique trial ID back to your name and/or CHI). For the purposes of this trial, we will store the key separately from the trial data and it will only be used for the purposes of follow up by the WOS Safe Haven, as explained above.
  • Your pseudonymised data will be held on a secure electronic data capture platform called CASTOR (in Europe) and stored in the cloud. This is approved by NHSGGC. Your pseudonymised data will then be transferred to myDNA laboratory, GenebyGene, (to link with your DNA samples in the US) as well as myDNA Life (myDNA in Melbourne Australia) to generate the corresponding pharmacogenomic report. Your pseudonymised data will also be transferred quarterly over the life of the trial to the University of Glasgow and provided to Robertson Centre for Biostatistics Clinical Trials Unit (University of Glasgow) for analysis.
  • Your data privacy and security will be maintained throughout the trial, the CASTOR electronic form will hold your unique trial ID and pseudonymised data. Your email address will also be collected if you have provided consent to allow the clinical research team to send health surveys. Your email, postal address or telephone number will be used to send health surveys and reminders if they have not been completed. The contact details that you have provided will be used by the clinical research team only during the trial period, for example a member of the research team may phone you to remind you about the follow up surveys. If you have consented to be contacted about future research, you may be contacted after the trial regarding relevant future research opportunities. The whole research team will be responsible for data collection ensuring the standard operating procedures, clinical governance procedures are followed and trained when it comes to entering your data.
  • Your pharmacogenomic report will be uploaded to the Nucleus portal (part of myDNA) to be accessed by the trial team, a copy will be added to CASTOR electronic form and transferred to the Robertson Centre for Biostatistics Clinical Trials Unit (University of Glasgow). Your pharmacogenomic report will not be included in your healthcare records. Your clinical team will be able to view a summary of the report’s recommendations and will decide to make any medication changes based on this at a single point during the trial. The full pharmacogenomic report will be held securely in the clinical trial platform system and in paper form in an NHS office. These will only be accessible by the research team.
  • Following data analysis, the Robertson Centre for Biostatistics Clinical Trial Unit, University of Glasgow and WOS Safe Haven Data will archive the anonymised data will be archived for 10 years.
• What are the possible disadvantages and risks of taking part?
  • It is possible that during the course of the trial, you may be prescribed a new medication by your GP or hospital team who will not have access to the full pharmacogenomic test result. The information obtained from the pharmacogenomic test will only be used to make a decision once within the trial, either around 10 days after recruitment for those in the intervention arm, or after 6 months for those in the standard care arm. The result will not be included in your hospital/healthcare records and will not be used for any future prescribing decisions. This approach has been taken as pharmacogenetic testing is not conducted routinely in the standard NHS lab and we must follow NHS guidelines to keep participants safe during the trial. If pharmacogenomic testing is made routinely available based on our research, if you consent to future contact, we will get in touch with you to consider having the test done again.
  • Occasionally, the cheek swab taken is not suitable for genetic testing or there can be an issue with the laboratory equipment. If this happens then we will ask you to provide another sample. We will post the cheek swab kit to you for a repeat test, with instructions and a self-addressed envelope for return.
  • When blood samples are taken at approximately 4 weeks, sometimes bruising may occur at the area where the needle is placed, if this does occur the bruising usually subsides over 1-14 days.
• What are the possible benefits of taking part?
  • For many participants there is little to no benefit in taking part. For others, changes made to medicines may reduce the chances of side-effects. It should be noted that not all medication side-effects are due to genetics, and so some side-effects may not be prevented by involvement in the PHOENIX trial.
• What will happen if I do not want to carry on with the study?
  • You can decide to withdraw from the trial at any time, for any reason, without explanation.
  • You can advise us if you wish for the research team to destroy any samples that have been collected or withdraw you from follow up.
  • You can advise the clinical research team for data that have been collected to be destroyed.
  • In certain circumstances, following review of your pharmacogenetic test report, the medication change by your clinician may have already occurred and this cannot be erased or undone.
• What happens at the end of the trial?
  • Following completion of your 3 month health survey, you will be informed which group you have been randomised to.
  • Over 12 months, the research team will follow up your health through the West of Scotland (WOS) Safe Haven. WOS Safe Haven securely stores routinely collected NHS data from individuals in NHS Greater Glasgow and Clyde including blood results, hospital admissions, outpatient clinic attendances and prescribed medicines. The research team, with your permission, will send your unique hospital identification number (Community Health Index - CHI) to the Safe Haven team who will gather your data which is relevant to the trial. This data will be returned to the researchers at the end of the trial, when the research team receives this information, it will be linked only to your unique trial ID rather than your personal identifying information.
  • After all the patients have been recruited and have completed their follow-up, the trial will close to recruitment and the data collected will be analysed by independent statisticians.
  • The results will be published in peer-reviewed journals and presented at major conferences and meetings.
  • The results will inform the next steps in the route to getting pharmacogenomics adopted and implemented in the NHS.
• Who is organising and funding this trial?
  • The trial is funded by the University of Glasgow Living Laboratory and myDNA Life Australia Pty Ltd and is being co-sponsored by NHSGGC and the University of Glasgow.
• Has this trial been approved by an Ethics Committee?
  • The Scotland A Research Ethics Committee (24/SS/0064), which has responsibility for scrutinising all proposals for medical research on humans, has examined the proposal and has raised no objections from the point of view of research ethics.

• Download Full Participant Information Sheet (PIS)
• Download Short Participant Information Sheet (PIS)
• Our trial aims to be inclusive as possible and recruit participants who do not have capacity. If you are a NOK/Welfare Guardian/ Power of Attorney here is the PIS.Download Legal RepresentativeParticipant Information Sheet (PIS)

For Clinicians

Summary of patient activity flow in the PHOENIX Trial

• Screening
  Eligibility: A patient admitted to hospital prescribed a new drug that has a known pharmacogene.
  NHS GGC Safe Haven and QEUH HEPMA team will review prescriptions of all newly admitted patients in the QEUH to identify potential participants for recruitment to the trial. Outpatients will be identified by the treating clinician to the trial team. Patients may self-identify to the trial team.
• Recruitment
  A member of the trial team will approach the potential participant in the ward or outpatient clinic after consulting with the participant's clinical team. The potential participant will be invited to join the study and receive the relevant participant information material. Consent will be obtained.
• Sample Collection
  With consent the participant's buccal swab sample will be collected in accordance with the Manual of Procedures (MOP).
• PGx Report
  The pharmacogenomic test produces a report about the pharmacogenomics variants for an individual along with the associated published guidelines on these variants.
  This allows the clinical team to make an informed decision about a patients’ medication management tailored to their genetic profile.
  The trial physician will share the PGx results with the participant’s clinical team by arranging a brief meeting to review the report. As this is a research study, the PGx report is for single-use only and will not be added to the participant’s medical records. The treating physician will decide whether to act on the recommendations, based on the participant’s clinical condition and their professional judgement. This decision will be documented in the electronic Case Report Form (eCRF). If a medication change is made, the clinical trial team will be responsible for all associated documentation, including informing the patient and their GP.
• PHOENIX Drugs and Genes

  Medication-Gene Relationships
• Follow-up
  • Quality of life using the EQ-5D-5L questionnaire monthly for 6 months.
  • Adverse drug event questionnaire monthly for 3 months.
  • Blood sample as appropriate at approximately 4 weeks depending on the index drug.
• How You Can Support the Study
  • Mention the study briefly to eligible patients during ward rounds or handovers – a simple endorsement from you can make a big difference.
  • Reassure patients that:
    • Participation is entirely voluntary
    • The test is quick and non-invasive (just a cheek swab)
    • Their usual care will continue without any changes
  • Leave the rest to us – our research team will speak with the patient, take consent, and manage all study-related activities.
  • Coming soon: We’ll be hosting short educational sessions to share more about the trial and early insights from implementation.
  • Interested in collaborating? We are keen to explore partnerships in outpatient clinics to broaden the impact of PGx-guided prescribing.

Patient and Public Involvement and Engagement (PPIE) Insights

Our patient and public involvement group has helped shape the trial at every stage. They supported our approach to PGx testing and consent, and helped refine our patient materials. We thank them for their valuable contributions.

PPIE Report

Download PPIE Report

Study Design

Trial Design

Trial Progress

As of May 2025, over 125 participants have been recruited across 24 specialties. The first patient visit took place in April 2025. The trial continues to expand, with monthly updates on recruitment and key milestones.

Graphical recruitment data and summaries coming soon.

FAQs

• help_outlineWill this test tell me about disease risk?
  No, it only informs medication response.
• help_outlineWill my DNA be stored?
  Only if you consent. Otherwise, it will be destroyed after testing.
• help_outlineCan I leave the trial?
  Yes, at any time without affecting your care.
• help_outlineIs the test safe?
  Yes, it only uses a cheek swab and does not involve drugs or radiation.

Resources

• Full PHOENIX Trial Protocol (PDF)
• Patient Summary Leaflet (PDF)
• List of Drugs with PGx Implications

Contact Us

If you have any questions about the trial or want to get involved:

• Email: ggc.qeuhpharmacogenetics@nhs.scot
• Phone: +44 77XXXXXX
• Address: Queen Elizabeth University Hospital, 1345 Govan Rd, Glasgow G51 4TF