Paediatric clinical trials: regulatory framework, challenges and ethical issues

Postgraduate Thesis uoadl:2936308 108 Read counter

Unit:
Κατεύθυνση Κλινικές Μελέτες: Σχεδιασμός και Εκτέλεση
Library of the School of Health Sciences
Deposit date:
2021-02-23
Year:
2021
Author:
Skordili Dimitra-Evangelia
Supervisors info:
Ευστάθιος Καστρίτης, αναπληρωτής Καθηγητής Ιατρικής Σχολής ΕΚΠΑ
Μαγδαλινή Μήγκου, Ακαδημαϊκός Υπότροφος, Ιατρική Σχολή, ΕΚΠΑ
Θεόδωρος Σεργεντάνης, Ακαδημαϊκός Υπότροφος, Ιατρική Σχολή, ΕΚΠΑ
Original Title:
Παιδιατρικές κλινικές μελέτες: ρυθμιστικό πλαίσιο, προκλήσεις και ηθικά ζητήματα
Languages:
Greek
Translated title:
Paediatric clinical trials: regulatory framework, challenges and ethical issues
Summary:
The first chapter analyzes the regulatory framework of pediatric clinical trials. The milestone that signed the beginning of the modern paediatric clinical research, with care in defining the proper requirements and ethical issues related to this vulnerable population, was represented by the introduction of international regulations on paediatric subjects. These regulations have been defined independently in the most developed countries, but in accordance to unified guidelines suggested by the ICH.
The second chapter deals with ethical issues and the challenges of pediatric clinical trials. Ethics are an integral part of research, from the conception of an idea to the publication of its results. Pediatric clinical research has multiple ethical implications that represent a large part of the difficult process of performing pediatric clinical trials. These effects are the focus of all the regulations that have been implemented on this issue and are under constant improvement and implementation as there are still some gray areas. Moreover, in this chapter, I tried to give the reader a more detailed overview of what obstacles can be encountered during the conduction of a paediatric clinical trial and suggested feasible ways to deal with them, hoping that this under-developed branch of the pharmaceutical research may grow further and lead to the successful labelling of new treatments for the paediatric population.
The third chapter examines the epidemiology, natural history, complications and management of acute otitis media in the pediatric population and a clinical trial entitled: "a placebo-controlled trial of antimicrobial treatment for acute otitis media" is analyzed in order to examine the efficacy of antimicrobial treatment in children with acute otitis media.
Main subject category:
Health Sciences
Keywords:
Paediatric, Clinical trials, Regulatory framework, Challenges, Ethical issues
Index:
No
Number of index pages:
0
Contains images:
Yes
Number of references:
139
Number of pages:
85
File:
File access is restricted only to the intranet of UoA.

Skordili Dimitra Evangelia Master.pdf
2 MB
File access is restricted only to the intranet of UoA.