Pharmacogenetics, Therapeutic Drug Monitoring (TDM) and Active Pharmacovigilance as Innovative Tools Aimed at the Optimisation/ Appropriateness of Drug Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-10

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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:

1. 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.
2. 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.

Conditions

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Adverse Drug Reaction (ADR)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult patients

Adult cancer patients

Pharmacogenetics, TDM and MedReview

Intervention Type OTHER

Patients will undergo pharmacogenetics, TDM and MedReview analyses according to the study protocol

Pediatric patients

Pediatric patients with chronic inflammatory diseases

Pharmacogenetics, TDM and MedReview

Intervention Type OTHER

Patients will undergo pharmacogenetics, TDM and MedReview analyses according to the study protocol

Interventions

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Pharmacogenetics, TDM and MedReview

Patients will undergo pharmacogenetics, TDM and MedReview analyses according to the study protocol

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No