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Alternative title:

Selected aspects of conducting clinical trials in Poland from the perspective of an oncology center (review paper)

ORCID:

0000-0001-5940-4112

Subject and Keywords:

clinical trials   GCP   quality of life   patient-reported outcomes

Abstract:

Clinical trials are a very important area of operation of medical institutions in Poland. The aim of the considerations undertaken in this study was to identify and characterize the aspects of conducting clinical trials from the perspective of an oncology center. The goal was achieved through literature studies, presentation and analysis of secondary research results and their interpretation. Critical analysis of the literature covering articles in national and international journals as well as reports of wellknown institutions published in the first two decades of the 21st century. The area of interest includes economic, health and social determinants that do not exhaust the topic. Among the economic aspects, human resources, technical, infrastructure and financial resources were identified. As part of health and social determinants, one should take into account epidemiological data which show that every year the number of people falling ill with cancer increases and also information about the patient’s quality of life. The intention of the article is to indicate those conditions for conducting clinical trials that have the greatest impact on the need, safety and quality of their realization in an oncology center. The factors were discussed from the perspective of the participants in the process, i.e. sponsor, research center, investigators, patients and the government.

Place of publishing:

Wrocław

Publisher:

E-Wydawnictwo. Prawnicza i Ekonomiczna Biblioteka Cyfrowa. Wydział Prawa, Administracji i Ekonomii Uniwersytetu Wrocławskiego

Date issued:

2020

Detailed Type:

e-książka

Identifier:

ISBN: 978-83-66601-24-6 (druk)   ISBN: 978-83-66601-25-3 (online)

DOI:

10.34616/23.20.128

Language:

pol   eng

Relation:

(E-Monografie ; No. 170)

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Access rights:

The use of this material is allowed only with accordance of applicable rules of fair use or other exceptions provided by law, and any broader use requires the permission of the authorized entity

License:

Making materials available on the basis of the agreement with the owner of the property copyrights

Rights holder:

Copyright by Wydział Prawa, Administracji i Ekonomii Uniwersytetu Wrocławskiego

Autor opisu:

WR U/PAdal