Pharmacogenomics Registry to Assess Clinical Utility
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 340,778
- 主要终点
- Meaningful Change
研究概览
简要总结
The PREACT Registry aims to see whether data from Pharmacogenomic Testing (PGx) can help healthcare providers manage patient medication regimens and assess if the testing has an effect on reducing medication side effects, hospitalizations and emergency department visits.
The way an individual processes a drug is in part determined by their genes, and there is known to be genetic variation between humans in the way drugs are metabolized. The study of the way genes affect a person's response to drugs is known as "Pharmacogenomics."
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pharmacogenomic testing has been performed within 12-months prior to eligibility assessment for genes known to influence metabolism of at least one target drug
- •Subject is 2 years of age or older
- •Subject is not taking an investigational medication or in a clinical trial that would interfere with participation in the registry
排除标准
- •Subject's medical and medication history is unavailable over the 90-day period preceding the receipt of pharmacogenomic test results
- •Subject (or subject's parent/guardian) is unable to provide an accurate history due to mental incapacity, in the Investigator's opinion.
结局指标
主要结局
Meaningful Change
时间窗: 90 day
Binary occurrence of meaningful change in drug regimen, defined for each subject as: * A genotype known to affect a target drug is identified by pharmacogenomic testing, and * The treating physician makes at least one target drug regimen change in dose, frequency, route of administration, drug discontinuation, addition or substitution.
次要结局
- Number of target drug adverse events (TDAE)(90 day retrospective; 90 day prospective)
- Target drug related emergency department visits(90 day retrospective; 90 day prospective)
- Target drug related hospitalizations(90 day retrospective; 90 day prospective)
- Changes in target drug regimen(90 days retrospective; 90 days prospective)