Title:

Ethical aspects of using methodological and organisational accelerators in clinical trials

Author:

Klaś, Katarzyna

Subject:

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

Abstract:

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.

Place of publishing:

Kraków

Level of degree:

2 - studia doktoranckie

Degree discipline:

choroby zakaźne ; onkologia ; farmakologia

Degree grantor:

Rada Dyscypliny Nauki o zdrowiu

Promoter:

Waligóra, Marcin

Date:

2025

Date issued:

2025

Type:

Praca doktorska

Call number:

ZB-143793

Language:

pol; eng

Access rights:

nieograniczony