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临床试验/NCT05504135
NCT05504135已完成不适用

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

Nalagenetics Pte Ltd1 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2022年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
222
试验地点
1
主要终点
Overall satisfaction of patient

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who experienced at least one of the following diseases, or is at risk of developing them:
  • Diabetes Mellitus
  • Hypertension
  • Hyperlipidaemia
  • Ischaemic Heart Disease
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Major Depression

排除标准

  • Below ages 21 and above ages 65

结局指标

主要结局

Overall satisfaction of patient

时间窗: 12 months

Via survey at month 12 of the study

Turnaround time of genotype result, compared to expected

时间窗: 6 months

Overall satisfaction of site principal investigators

时间窗: 6 months

Via survey done at month 6 of the study

Overall satisfaction of prescribing physicians

时间窗: 12 months

Via survey done at month 12 of the study

Prevalence of clinically actionable genotypes

时间窗: 12 months

The number of patients receiving recommendations that includes a certain follow up action which includes monitoring, change of dosing or change of prescription.

Recommendation acceptance rate

时间窗: 12 months

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

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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