Decentralizirani model kao alat za unaprjeđenje kliničkih ispitivanja

professional thesis

• Author: Maja Barać
• Mentor: Srećko Marušić (mentor)
• Committee member: Iva Mucalo (predsjednik povjerenstva)
• Committee member: Srećko Marušić (član povjerenstva)
• Committee member: Maja Ortner Hadžiabdić (član povjerenstva)
• Granter: University of Zagreb; Faculty of Pharmacy and Biochemistry; Zagreb
• Defense date and country: 2023-10-13, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Pharmacy; Pharmacy

Abstract

Cilj istraživanja
Cilj ovog specijalističkog rada je istražiti utjecaj prilagodbe modela kliničkih ispitivanja s
tradicionalnog na decentralizirani/hibridni model s obzirom na regrutaciju ispitanika,
potpisivanje informiranog pristanka, opskrbu ispitivanim lijekom, kontrolu i nadzor ispitanika
(monitoring), ali i izravan utjecaj takva modela na sponzore (naručitelje ispitivanja), ugovorne
istraživačke organizacije koje pomažu sponzorima u provođenju kliničkih ispitivanja te na
sigurnost i zaštitu samih ispitanika.
Materijali i metode
U izradi rada koristiti će se pregled stručne literature na temu decentraliziranih kliničkih
ispitivanja s posebnim naglaskom na promjenu modela kliničkih ispitivanja tijekom pandemije
virusa COVID-19 te rata u Ukrajini, lokalnih pravilnika i EU direktiva, federalnih zakona SADa te ICH smjernica.
Rezultati
Istraživanje je prikazalo zastupljenost decentraliziranih kliničkih ispitivanja po terapijskim
područjima, sponzorima i ugovornim istraživačkim organizacijama te po zemljama, kao i
komparaciju između tradicionalnog i decentraliziranog modela kliničkih ispitivanja s obzirom
na financijske aspekte, kvalitetu i robusnost podataka iz kliničkih ispitivanja te zaštitu prava
ispitanika (etički aspekti).
Zaključak
Na temelju rezultata istraživanja zaključuje se da je decentralizirani model kliničkih ispitivanja
financijski isplativiji za sponzora od tradicionalnog modela, da je više usmjeren ka potrebama
ispitanika te da kvaliteta i robusnost podataka iz decentraliziranog kliničkog ispitivanja mogu
parirati onima iz tradicionalnog modela kliničkih ispitivanja.

Abstract (english)

The aim of the investigation
The aim of this review is to investigate the impact of the adaptation of the clinical trial model
from the traditional to the decentralized/hybrid model in regards with recruitment of subjects,
signing of informed consent, supply of study drug, control and supervision of subjects
(monitoring), but also the direct impact of this model on trial sponsors and contract research
organizations that assist sponsors in conducting clinical trials, and the safety and protection of
the subjects themselves.
Materials and methods
In the preparation of the paper, a review of the professional literature on the topic of decentralized
clinical trials will be used, with a special emphasis on the change in the model of clinical trials
during the COVID-19 virus pandemic, local ordinances and EU directives, US federal laws and
ICH guidelines.
Results
The research showed the representation of decentralized clinical trials as well as a comparison
between traditional and decentralized models of clinical trials with regard to financial aspects,
quality and robustness of data from clinical trials, protection of the rights of subjects (ethical
aspects).
Conclusion
Based on the results of the research, it is concluded that the decentralized model of clinical
trials is financially more profitable for the sponsor than the traditional model, that it is more
focused on the needs of the subjects, and that the quality and robustness of the data from the
decentralized clinical trial can match those from the traditional model of clinical trials.

• Keywords: klinička ispitivanja; decentralizirana klinička ispitivanja
• Keywords (english): clinical trials; decentralized clinical trials
• Language: croatian
• URN:NBN: urn:nbn:hr:163:938598
• Study programme: Title: Clinical pharmacy; Study programme type: university; Study level: postgraduate specialist; Academic / professional title: sveučilišni/a magistar/sveučilišna magistra kliničke farmacije (sveučilišni/a magistar/sveučilišna magistra kliničke farmacije)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2024-01-30 12:30:05