NCT05825794

Active Pharmacovigilance of Anti-cancer Medicines

Active Pharmacovigilance of Anti-cancer Medicines in Pediatric and Young Adult Patients.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: IRCCS Burlo Garofolo · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: —

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.

Conditions

• Oncology
• Drugs
• Pharmacovigilance

Timeline

• Start date: 2021-10-28
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2023-04-24
• Last updated: 2023-04-24

Locations

1 site across 1 country: Italy