PHOENIX is a pragmatic pilot, parallel-group, individually randomised controlled trial evaluating pre-emptive pharmacogenomic (PGx) panel testing in acute NHS secondary care settings within NHS Greater Glasgow and Clyde hospitals and the NHS Golden Jubilee National Hospital. Adults newly prescribed an eligible PGx-relevant index drug are randomised 1:1 to PGx-guided care or to standard care with delayed PGx testing. The protocol includes blinded outcome adjudication and linkage-based outcome ascertainment.
Multigene PGx panel testing has the potential to reduce adverse drug reactions (ADRs), treatment failures, and downstream healthcare use by aligning prescribing with germline genetic variation. Prior work, including the PREPARE trial, reported roughly a 30% reduction in clinically relevant ADRs with pre-emptive multigene panels, but methodological limitations (open-label design, patient-reported endpoints and subsequent critiques) limit generalisability to NHS decision-making. Whether panel-based PGx delivers measurable benefit in acute NHS secondary care—where prescribing is often time-critical, patient populations tend to be older and multimorbid, and outcomes can be adjudicated using linked records—remains uncertain. PHOENIX is designed to address this evidence gap.
PHOENIX is conducted as a pragmatic pilot RCT with individual randomisation and blinded outcome adjudication. Recruitment sites are hospitals within NHS Greater Glasgow and Clyde and the NHS Golden Jubilee National Hospital. The study uses a data-driven screening approach that integrates electronic prescribing, community prescribing linkage and record review to identify adults newly prescribed an eligible index drug.
Eligible participants are adults who are newly prescribed a PGx-relevant index drug. Identification is performed through an integrated screening system accessing electronic prescribing data, linked community prescribing records and manual record review. Once identified and consented, participants are randomised to either the intervention or control arm. Further eligibility criteria and detailed inclusion/exclusion lists were not reported in the source summary.
Participants randomised to the intervention arm provide a buccal swab for DNA. Genotyping is performed in a Clinical Laboratory Improvement Amendments/College of American Pathologists (CLIA/CAP)-accredited laboratory. A report based on Clinical Pharmacogenetics Implementation Consortium (CPIC) and Dutch Pharmacogenetics Working Group (DPWG) recommendations is returned to inform care, typically within approximately 10 days. The returned results are for research use only. Participants randomised to standard care receive delayed PGx testing.
The primary outcome is index-drug-related ADR or treatment failure occurring within 3 months of the index prescription. Outcomes are adjudicated using Common Terminology Criteria for Adverse Events (CTCAE) version 6 alongside validated causality assessment tools. Deterministic linkage through the West of Scotland Safe Haven supports outcome ascertainment.
Secondary outcomes include ADR severity, hospitalisations, mortality, uptake of actionable prescribing changes, biomarker levels, health-related quality of life measured with the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), and broader healthcare utilisation metrics.
The trial aims to recruit between 2,000 and 4,000 participants. Recruitment is constrained by a fixed operational end date of 30 September 2026. The source summary does not report a formal sample size calculation, power assumptions, or disease-specific subgroup targets.
The primary analysis population is intention-to-treat. The primary statistical model is logistic regression adjusted for stratification factors. Additionally, a within-trial cost-utility analysis will estimate cost per quality-adjusted life year (QALY) to inform economic decision-making. Details of covariates, handling of missing data, planned subgroup analyses or sensitivity analyses were not reported in the provided summary.
The study has research ethics approval from Scotland A Research Ethics Committee (reference 24/SS/0064; IRAS 344412; NHS R&I INGN24MG113). Co-sponsors are NHS Greater Glasgow and Clyde and the University of Glasgow. Trial registration is NCT06907784. Findings will be disseminated via peer-reviewed publication, conference presentations, patient and public involvement channels, co-produced lay summaries and the trial website.