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

Direzione centrale salute, politiche sociali e disabilità

Status: Enrolling

Conditions: Adverse Drug Reaction (ADR)

Treatments: Other: Pharmacogenetics, TDM and MedReview

Study type: Observational

Funder types: Other

Identifiers

NCT06822959

CRO-2022-14

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 450 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

450 participants in 2 patient groups

Adult patients

Description:

Adult cancer patients

Treatment:

Other: Pharmacogenetics, TDM and MedReview

Pediatric patients

Description:

Pediatric patients with chronic inflammatory diseases

Treatment:

Other: Pharmacogenetics, TDM and MedReview