Active Pharmacovigilance of Anti-cancer Medicines

Recruiting

• Conditions: Drugs; Pharmacovigilance; Oncology

• Registration Number: NCT05825794
• Lead Sponsor: IRCCS Burlo Garofolo

Brief Summary

Pharmacovigilance (PV), defined by the World Health Organization (WHO) as the "science and activities related to the detection, evaluation, understanding and prevention of adverse effects or any other drug-related problem", aims to improve patient safety and quality of life. There are several objectives of PV, starting with the collection and management of safety data, to promote the safe and effective use of medicines. PV also aims to provide information on drug safety to health professionals and patients, and it contributes to updating drug labels. Finally, it is active in risk management, risk minimization and the prevention of adverse effects and other drug-related problems. As defined by WHO, an adverse event (AE) is "any untoward medical occurrence that may be present during treatment with a medicine, but which does not necessarily have a causal relationship with this treatment". When there is a causal relationship with the treatment, an AE is classified as an adverse drug reaction (ADR). The collection and reporting of AEs is a process that starts from the drug development phase and proceeds continuously throughout the life cycle of the drug, and it aims to assess the benefits-to-toxicity ratios (in other words, the safety and efficacy) of all medicines. Reports of ADRs must accurately describe the case and be meaningful to health professionals worldwide. The aim of this project is to evaluate the impact of an active prescription surveillance of anti-cancer drugs carried out by the clinical pharmacist in pediatrics and young adults.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-28
• Study First Submitted: 2023-03-29
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-11
• Last Update Submitted: 2023-04-11
• Study First Posted: 2023-04-24
• Last Update Posted: 2023-04-24
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients aged <25 years;
• receiving cytotoxic, targeted-therapy, immunotherapy drugs for the treatment of solid and hematologic cancers
• giving consent to study participation

Exclusion Criteria

• presence of cognitive problems

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the number of grade 3-5 ADRs reported during the active surveillance period with the number of grade 3-5 ADRs reported in the previous years	Through study completion, an average of 3 years	Period of equal length will be compared
To quantify the number of grade 3-5 ADRs reported during the active surveillance period	Through study completion, an average of 3 years	ADRs grades will be standardized using the Common Terminology Criteria for Adverse Events (CTCAE) v4.3.

Trial Locations

Locations (1)

IRCCS materno infantile Burlo Garofolo; 🇮🇹 Trieste, Italy