Active Pharmacovigilance of Anti-cancer Medicines

Oncology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05825794
• Other study ID #: AIFA FVG 2019
• Status: Recruiting
• Start date: October 28, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: IRCCS Burlo Garofolo
• Contact: Marta Paulina Trojniak, PharmD
• Phone: +390403785111
• Email: martapaulina.trojniak[@]burlo.trieste.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: N/A to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Drugs
• Neoplasms
• Oncology
• Pharmacovigilance

Locations

Country	Name	City	State
Italy	IRCCS materno infantile Burlo Garofolo	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To quantify the number of grade 3-5 ADRs reported during the active surveillance period	ADRs grades will be standardized using the Common Terminology Criteria for Adverse Events (CTCAE) v4.3.	Through study completion, an average of 3 years
Primary	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	Period of equal length will be compared	Through study completion, an average of 3 years