Active Pharmacovigilance of Anti-cancer Medicines

NCT05825794 | Unknown

• 1 other identifier: AIFA FVG 2019
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology; Drugs; Pharmacovigilance

Keywords

Oncology; Drugs; Active pharmacovigilance

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric and young adult patients requiring the administration of anticancer drugs

You may qualify if:

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

You may not qualify if:

• presence of cognitive problems

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

IRCCS materno infantile Burlo Garofolo

Trieste, 34137, Italy

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Marta Trojniak, PharmD

  IRCCS materno infantile Burlo Garofolo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Paulina Trojniak, PharmD

CONTACT

+390403785111; martapaulina.trojniak@burlo.trieste.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 24, 2023
• Study Start: October 28, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

IT (1)