To hear about similar clinical trials, please enter your email below
Trial Title:
Active Pharmacovigilance of Anti-cancer Medicines
NCT ID:
NCT05825794
Condition:
Oncology
Drugs
Pharmacovigilance
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Oncology
Drugs
Active pharmacovigilance
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
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.
Criteria for eligibility:
Study pop:
Pediatric and young adult patients requiring the administration of anticancer drugs
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
N/A
Maximum age:
25 Years
Locations:
Facility:
Name:
IRCCS materno infantile Burlo Garofolo
Address:
City:
Trieste
Zip:
34137
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Marta Trojniak
Phone:
+390403785111
Email:
marta.trojniak@burlo.trieste.it
Start date:
October 28, 2021
Completion date:
December 31, 2023
Lead sponsor:
Agency:
IRCCS Burlo Garofolo
Agency class:
Other
Source:
IRCCS Burlo Garofolo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05825794
