Pharmacogenetics, Therapeutic Drug Monitoring (TDM) and Active Pharmacovigilance as Innovative Tools Aimed at the Optimisation/ Appropriateness of Drug Therapy and the Minimisation of the Risks of ADRs in Clinical Practice: a Multidisciplinary Approach Exportable at National Level
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Patients treated with study drugs tested with pharmacogenetic and TDM analysis
研究概览
简要总结
The primary goal of this observational study is to evaluate the feasibility of implementing a multidisciplinary approach based on pharmacogenetics, TDM (Therapeutic Drug Monitoring) and MedReview into the clinical practice in order to optimize the appropriateness of drugs prescription and to minimise the risk of Adverse Drug Reactions (ADRs) in adult cancer patients and in pediatric patients affected by chronic inflammatory diseases. This approach of active pharmacovigilance will also allow a better definition of the causality assessment of ADRs through the direct implementation of data quality in the reporting forms. The study may therefore constitute an example of an approach for both the prevention of ADRs and the optimization of drug use, and for the integration of pharmacogenetics, TDM, and the MedReview data into the National Pharmacovigilance Reports for an improved and innovative evaluation of adverse events, aiming at the implementation of this approach in the regional context.
详细描述
Primary aim of the study:
To implement the use of pharmacogenetics, TDM, and MedReview at the regional level supporting their utility through an observational approach to assess the effects of these innovative methods, already active in IRCCS, for the optimization of appropriate drug use and minimization of ADR risk in adult and pediatric oncology patients, as well as pediatric patients with chronic inflammatory diseases. Specifically, the aim is to evaluate the incidence of ADRs in patients treated based on pharmacogenetics, TDM, and MedReview compared to historical cases treated according to the standard of care before the implementation of the proposed innovative methodologies.
Secondary aims of the study:
- To evaluate the "Causality Assessment" between ADR and drug based on the enhanced data quality deriving from the integration of pharmacogenetics, TDM and MedReview into the Pharmacovigilance report.
- To propose the systematic integration of the results related to pharmacogenetics, TDM, and MedReview within the existing fields of the current ADR reporting form. This aims to develop a proposal for updating AIFA procedures related to the inclusion of this type of evidence-based information in the National Pharmacovigilance Network (RNF), with a potential update of the reporting form.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are candidates for therapy with:
- •Abemaciclib,
- •Palbociclib,
- •Ribociclib,
- •Letrozole,
- •Tamoxifen,
- •Olaparib,
- •Niraparib,
- •Rucaparib,
- •Imatinib,
- •Sunitinib,
- •Sorafenib,
- •Regorafenib,
- •Lenvatinib,
- •Irinotecan,
- •Capecitabine,
- •5-Fluorouracil,
- •Infliximab,
- •Cyclophosphamide,
- •Methotrexate,
- •Adalimumab,
- •6-Mercaptopurine/Azathioprine
排除标准
- 未提供
研究组 & 干预措施
Adult patients
Adult cancer patients
干预措施: Pharmacogenetics, TDM and MedReview (Other)
Pediatric patients
Pediatric patients with chronic inflammatory diseases
干预措施: Pharmacogenetics, TDM and MedReview (Other)
结局指标
主要结局
Patients treated with study drugs tested with pharmacogenetic and TDM analysis
时间窗: Up to 2 years
Percentage of patients treated with study drugs tested with pharmacogenetic and TDM analysis on total patients treated
MedReview reports
时间窗: Up to 2 years
Number of MedReview reports
ADRs in patients treated on the basis of pharmacogenetics, TDM and MedReview
时间窗: Up to 2 years
Incidence of ADRs in the study cohorts
Comparison of ADRs in patients treated on the basis of pharmacogenetics, TDM and MedReview and retrospective data
时间窗: Up to 2 years
Difference in incidence of ADRs in the prospective cohort will be tested against historical data with binomial test
次要结局
- Integration of pharmacogenetics, TDM and MedReview information in the existing tool for the evaluation of "Causality assessment" between ADR and specific drug(Up to 2 years)
- Proposal for updating the pharmacovigilance reporting forms including Pharmacogenetics, TDM and MedReview information in the National Network of Pharmacovigilance(Up to 2 years)
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 v3(Up to 2 years)
- Costs of ADRs management(Up to 2 years)
- Concordance between plasmatic concentration measured with conventional methods and with new methods such as Dried Blood Spot (DBS)(Up to 2 years)
- Correlation between pharmacogenetic profile and drug exposure (TDM)(Up to 2 years)
- Correlation between ADRs, TDM and pharmacogenetics analyses(Up to 2 years)