Implementation of Pre-emptive Pharmacogenomics Testing in Singapore-based Private Hospital Institutions (PPT Study)

In collaboration with Raffles Medical Group, we will be recruiting 500 patients and following them for the next 3-12 months to see whether pharmacogenomics information provided in the Raffles' Electronic Health Records (EHR) will be used by physicians to personalize patients' prescriptions.

Study Overview

• Status: Recruiting
• Conditions: Pre-emptive Pharmacogenomics
• Intervention / Treatment: Diagnostic test: Pharmacogenomics Testing

Detailed Description

Pre-emptive genotyping provides relevant genomic data to physicians to facilitate prescribing and to facilitate checking of prescriptions by pharmacists to ensure drug safety and efficacy. This essential information should be incorporated into electronic healthcare systems and should be readily available. The effectiveness of pre-emptive genotyping to reduce adverse drug reactions (ADRs) is unknown in Singapore. Hence, this study is designed to evaluate whether it is feasible to implement large scale pre-emptive genotyping program at a hospital in Singapore and aim to integrate genomic medicine into clinical practice to improve drug safety and efficacy.

This study involves the testing of feasibility of pharmacogenomic genotyping in hospitals whereby our pharmacogenomics panel tests for 5 genes (CYP2D6, CYP2C9, CYP2C19, SLCO1B1 and HLA-B*58:01) which influences patient's response to more than 165 medications. Reports will be generated for all drugs that have been reported to be in CPIC Level A/B of association with the genes/haplotypes. The patients who are given these tests for free are recommended due to having experienced at least one of the diseases in our list or is at a risk of developing them.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 188770
    • Recruiting
    • Raffles Hospital
    • Contact: Beatrix Lee; Phone Number: 6311 2222; Email: remc@rafflesmedical.com
    • Principal Investigator: Shih Kiat Chng, Dr
    • Principal Investigator: Angeline Wee, Dr
    • Sub-Investigator: Astrid Irwanto, Dr
    • Sub-Investigator: Alexandre Chan, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

500 patients visiting Raffles Hospital in Singapore

Description

Inclusion Criteria:

• Patients who experienced at least one of the following diseases, or is at risk of developing them:

  1. Diabetes Mellitus
  2. Hypertension
  3. Hyperlipidaemia
  4. Ischaemic Heart Disease
  5. Stroke
  6. Osteoarthritis
  7. Rheumatoid Arthritis
  8. Gout
  9. Anxiety

  10. Major Depression

      Exclusion Criteria:

• Below ages 21 and above ages 65

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RMG Patients	Diagnostic test: Pharmacogenomics Testing; To test if pharmacogenomics information (produced from testing) included by us in the Raffles' Electronic Health Records (EHR) will be used by physicians to personalize patients' prescriptions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Turnaround time of genotype result, compared to expected		6 months
Overall satisfaction of patient	Via survey upon recruitment	0 months
Overall satisfaction of patient	Via survey at month 3 of the study	3 month
Overall satisfaction of patient	Via survey at month 12 of the study	12 months
Overall satisfaction of site principal investigators	Via survey done at month 6 of the study	6 months
Overall satisfaction of prescribing physicians	Via survey done at month 12 of the study	12 months
Prevalence of clinically actionable genotypes	The number of patients receiving recommendations that includes a certain follow up action which includes monitoring, change of dosing or change of prescription.	12 months
Recommendation acceptance rate	Defined by: (1) Number of physicians who are interested to consider pharmacogenomics information to guide prescription, measured by click-through rate of Pharmacogenomics Access Button; (2) Number of changes made to the medications post-PGx testing; (3) Data obtained from satisfaction survey for prescribing physicians	12 months

Collaborators and Investigators

• Sponsor: Nalagenetics Pte Ltd
• Investigators: Principal Investigator: Melvin Wong, Dr, Raffles Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Anticipated): March 3, 2023
• Study Completion (Anticipated): March 3, 2024

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 14, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 2, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: SG-RMG-01-20190401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No