Clinical trial NCT05825794: Active Pharmacovigilance of Anti-cancer Medicines
Official title: Active Pharmacovigilance of Anti-cancer Medicines in Pediatric and Young Adult Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oncology
Drugs
Pharmacovigilance
Keywords: Oncology
Drugs
Active pharmacovigilance
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 50
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric and young adult patients requiring the administration of anticancer drugs

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.


Eligibility criteria: 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

Primary outcomes:
measure: To quantify the number of grade 3-5 ADRs reported during the active surveillance period
timeFrame: Through study completion, an average of 3 years
measure: 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
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS materno infantile Burlo Garofolo
Study officials:
affiliation: IRCCS materno infantile Burlo Garofolo
name: Marta Trojniak, PharmD
role: PRINCIPAL_INVESTIGATOR
References: