Tytuł:

Ethical aspects of using methodological and organisational accelerators in clinical trials

Autor:

Klaś, Katarzyna

Temat i słowa kluczowe:

bioethics ; ethics of clinical trials ; accelerating clinical trials ; COVID-19 pandemie ; oneology

Abstrakt:

The main objective of this thesis was to analyse the ethical aspects of using methodological and organisational accelerators in clinical trials. In this context, methodological and organisational accelerators refer to new Solutions in the design and methodology of clinical trials, as well as institutional and regulatory improyements. Their purpose is to enable faster, morę optimised, patient-centred clinical trials. The thesis consists of four publications: two empirical analyses based on clinical trial registry data, one systematic review with meta-analysis, and one normative ethical analysis. The research was conducted in two stages. The first stage involved analysing selected ethical aspects of clinical trials testing methods of treating and preyenting diseases caused by the SARS-CoV-2 virus. The second stage involved analysing selected ethical aspects of new clinical research models in oneology. The ethical issues discussed relate to overarching principles of the ethical conduct of clinical trials, such as avoiding research waste and ensuring scientific and social yalue, as well as the principle of proportionality of risk and benefit.

Miejsce wydania:

Kraków

Stopień studiów:

2 - studia doktoranckie

Dyscyplina:

choroby zakaźne ; onkologia ; farmakologia

Instytucja nadająca tytuł:

Rada Dyscypliny Nauki o zdrowiu

Promotor:

Waligóra, Marcin

Data:

2025

Data wydania:

2025

Typ:

Praca doktorska

Sygnatura:

ZB-143793

Język:

pol; eng

Prawa dostępu:

nieograniczony